Top 5 Challenges in Clinical Trial Study Start-up and Pipeline Management

Study start-up and pipeline management are fraught with challenges that can hinder progress and efficiency. These complex processes involve meticulous planning, coordination, and execution from all parts of a research site organization, leaving ample opportunity for delays. Despite advances in technology and methodologies, research teams continue to face significant challenges that can extend timelines and increase costs. In this blog, we’ll explore the top five challenges in clinical trial study start-up and pipeline management and discuss how Devana Solutions’ PROPEL platform can help overcome these obstacles, ensuring streamlined and successful trial execution. 

Challenge 1: Site Selection and Activation 

Identifying and activating the right clinical trial sites is crucial, yet this process often presents a significant bottleneck for larger networks. The selection process involves evaluating sites for their patient population, infrastructure, previous performance, and capacity to conduct the trial efficiently. To stay competitive, networks want to distribute the right opportunities to the right sites, while sites want to be the first to respond to new opportunities with accurate, timely data. Anything that slows this process can be a problem in securing new trials from CROs and sponsors.  

Solution: PROPEL’s data-driven site selection tools help networks quickly identify optimal sites based on data already in the system, including historical performance, past recruitment efforts, investigator capabilities, and physical equipment. The platform also facilitates seamless communication and support during the activation phase, ensuring sites are ready to start trials promptly and have all the information they need. If responses from either side, or even external contacts such as CROs and sponsors, ever slow down or stop – PROPEL provides automated alerts to keep everyone on track. 

Challenge 2: Patient Recruitment and Retention 

Recruiting and retaining the appropriate number of participants within the required timelines is consistently a top challenge for research sites. Many trials fail to meet their enrollment targets, leading to delays and increased costs. 

Solution: Developing a comprehensive patient recruitment strategy that includes targeted outreach, education campaigns, and leveraging digital platforms can improve recruitment rates. Ensuring a positive patient experience and providing support throughout the trial can improve retention. PROPEL can help track methodologies from past trials, informing future decisions. And by integrating PROPEL with your CTMS, central teams can track real-time recruitment statuses throughout the entire life of a trial – all in one place.  

Challenge 3: Budget Management and Financial Planning 

Budget overruns and financial mismanagement are common issues in clinical trials. Inaccurate budgeting can lead to insufficient funding, impacting trial progress and outcomes. Tracking potential new incoming trials is also key, as knowing how much you have coming down your pipeline can help inform better decision making. 

Solution: PROPEL offers robust budgeting tools that provide real-time insights into financial status and even allows for projections of potential trials. By integrating project management features with budgeting capabilities and business development tools, PROPEL enables organizations to manage expenses more effectively, anticipate future financial needs, and maintain flexibility to adjust for unexpected costs. 

Challenge 4: Study Start-up Milestones 

Consistently advancing trials through study start-up can be difficult with many potential pitfalls and opportunities for delay. Additionally, navigating the regulatory landscape can be one of the most daunting aspects of any clinical trial, with numerous sets of regulation depending on indication and trial type. Staying compliant with these varying requirements while also managing to progress trials at a steady rate is critical to growing your organization. 

Solution: PROPEL centralizes and standardizes study start-up, tracking progress across all sites and measuring milestone completion metrics. Automated tasks and alerts are generated when tasks such as feasibility or PSV/SIV scheduling hit a snag, making sure delays are measured, visible, and readily addressed. PROPEL also provides powerful document management and automates many aspects of study start-up, including compliance workflows, providing real-time visibility into approval statuses. By streamlining the entire study start-up process, PROPEL helps ensure timely submissions and reduces the risk of tasks or entire trials falling behind. 

Challenge 5: Data Collection and Management  

Having real-time insight into how trials are progressing at various sites is key to growing your research organization. Ensuring the integrity and quality of data collected during a clinical trial is also vital, particularly to prove past successes to new CROs and sponsors. Inconsistent or lacking data collection methods can impact decision making and, ultimately, an organization’s bottom line.  

Solution: PROPEL makes it easy to track and monitor trial opportunities from CROs and sponsors, resulting in robust pipeline management where you can gain insights into potential trends and help forecast for future trials. As trials move through the system, PROPEL automatically captures metrics such as site responses, turnaround timing, milestone progress, and more. Powerful dashboards and reports make it easy to share insights and historic data both internally and externally with CROs and sponsors, helping win more opportunities based on your organization’s past accomplishments.   

Conclusion 

The challenges faced by clinical research organizations in study start-up and pipeline management are significant, but they are not insurmountable. By understanding these challenges and implementing strategic solutions with PROPEL’s comprehensive platform, research teams can enhance efficiency, reduce timelines, and ensure the successful execution of clinical trials. Embracing technological advancements, fostering strong collaborations, and maintaining a proactive approach to problem-solving are key to overcoming these hurdles and advancing clinical research. 

Devana Solutions  

A RealTime Software Solutions Company, Devana Solutionsis an innovative cloud-based clinical trial software provider that supports real-time collaboration between central research operations professionals and decentralized clinicians serving patients in diverse communities. Devana Solutions even bridges the technology access and data divide by seamlessly and securely connecting decentralized researchers to other mission-critical clinical trials systems.  

Let us show you in more detail what Better Data, Better Decisions, Better Outcomes could do for your clinical trial processes.Book a demo with Devana Solutions today to learn about our cloud-based data analytics clinical trial software for the clinical trials industry that integrates seamlessly with CTMS and other key systems to keep success in the crosshairs.  

Understanding the Current Site Sector Consolidation Trend

The clinical research industry is undergoing a profound transformation, driven by market consolidation and technological innovation. To adapt, clinical research sites are embracing innovation, increased collaboration, and strategic positioning to thrive. The site consolidation trend shows no sign of abating. In this blog post, we caught up with Barry Lake, co-founder at Devana Solutions, a RealTime Software Solutions Company. We wanted to better understand the driving forces behind the site consolidation trend and uncover key investment areas for sites aspiring to accelerate their growth and enhance their appeal to sponsors and investors. 

About our in-house industry expert, Barry Lake, Co-Founder and President of Devana Solutions: Before co-founding Devana Solutions, Barry Lake gained hands-on experience in site operations at a clinical research site in Charleston, South Carolina. In addition to managing his own site, he was part of a management team that established an early “network” of high-performing, independent yet affiliated sites that shared marketing and sales resources. He witnessed the emergence of strategic acquisitions and site consolidations, notably in 2015 when PPD acquired Synexus’s approximately 100+ sites and ICON acquired PMG Research’s 12 U.S. sites. In 2019, ICON further expanded by combining PMG’s U.S. footprint with MeDiNova’s European sites, forming the Accellacare Global Site Network, now comprising approximately 112 sites. 

Interview with Barry Lake

Q: Can you share your background and how it influenced your journey in the clinical trials industry? 

Barry Lake: Before co-founding Devana Solutions, I gained experience in site operations at a clinical research site in Charleston, South Carolina. This first-hand experience of the pain points of running a site, coupled with witnessing the emergence of strategic acquisitions and site consolidations, inspired me to pioneer the Devana Solution platform. Launched in 2016, Devana built a category-defining product that addresses the challenge with study start-up, pipeline management and business intelligence for sites, sponsors, and CROs. 

 

Q: Can you share your observations on the current trends shaping the clinical research landscape, particularly regarding site success and market consolidation? 

Barry Lake: Absolutely. We have been witnessing a significant shift in the clinical research industry, characterized by the consolidation of site networks. Strategic acquisitions and private equity investments are driving this trend, leading to the emergence of larger, integrated site networks. This consolidation presents both opportunities and challenges for sites as they maneuver through the complexities of modern clinical trials.  

Organizations transitioning from “boutique” businesses to sustainable enterprises are leveraging capital to increase their scale and value. Successful execution necessitates securing sufficient capital to sustain competitive advantage and drive growth. In the site sector consolidation, winners emerge by executing profitably and strategically accessing capital. 

If an organization makes the commitment to move beyond being a boutique business towards building truly sustainable enterprise value through a leading position therapeutically or through scale across a geographic footprint, over time, the leadership will face relentless and ever-increasing pressures stemming from their own commercial success. The good news for these site organizations is they will certainly be much more valuable in private equity’s eyes, assuming their leadership is open to leveraging more capital to increase their scale. Successful execution inevitably requires increasingly larger tranches of capital for any organization to sustain a balance sheet that enables them to maintain a competitive advantage and continue scaling and increasing their enterprise value over the long term.  

In other words, when an industry sector consolidates fueled by the efficient deployment of a massive amount of capital at scale (the role of the financial sector in every industry) it envelopes both types of companies in the sector: the losers and the winners. The losers in the clinical trial site sector will be those site organizations that cannot evolve into becoming one of leaders either by not performing profitably or, if they do, in fact, become profitable their ownership fails to seek sufficient capital to shore up their balance sheet and drive their growing dominance.  

I foresee that those organizations that fail to access more capital when they need it will be outmaneuvered over the long run by more savvy competitors with stronger balance sheets. As a result, the site organizations on the wrong side of market forces will either go out of business if they are unprofitable or, if they don’t seek more capital to shore up their balance sheet, be forced to eventually sell at a depressed value to a competitor or industry aggregators. 

The ultimate winners in this consolidation battle will be those site organizations who execute profitably and then attract and, are willing to accept, additional capital on reasonable terms at numerous inflection points along their growth journey. 

 

Q: How does essential site-based technology contribute to site success in this site consolidation market? 

Barry Lake: Technology can be a game-changer for clinical research sites looking to succeed in today’s competitive environment. Electronic solutions that replace error-prone paper-based processes, like Devana, enhance transparency, streamline workflows, and facilitate integration with the industry’s top CTMS providers including RealTime, CRIO and Clinical Conductor. Devana improves site business operations, accelerates study startup processes, and fosters efficiency across the entire clinical trial journey, from study start-up, execution to closeout. By leveraging advanced eClinical technology, sites can improve data accuracy, accountability, and position themselves as leaders within larger site networks. 

 

Q: What are some key strategies that clinical research sites can employ to capitalize on growth opportunities? 

Barry Lake: Strategic positioning is essential for clinical research sites. By focusing on areas of expertise, building strong relationships with sponsors and CROs, and investing in eClinical technology solutions built for clinical trials, sites can enhance their value proposition and attract increased investments. Additionally, collaboration and networking within larger site networks can open doors to new opportunities for growth and expansion. 

 

Q: What role does Devana play in shaping the future of clinical trials? 

Barry Lake: The private equity fueled site sector consolidation has continued to accelerate at a rapid pace heading in 2024 and Devana remains at the forefront of innovative eClinical solutions purpose-built to help sites scale faster. Devana delivers crucial transparency to site leadership and operating managers, shedding light on the upstream pipeline of trial opportunities and automating study startup workflows. In fact, on average, sites that have adopted Devana report 76% reduced contract budget and turnaround time, 14 hours saved in study activation, and 40% increased revenue. 

And the platform continues to shape the future of clinical trials through strategic partnerships like seamless integrations with industry-leading CTMS providers and cutting-edge new features such as our Query Feature, which allows central team members to query all sites within their network based on a given trial’s specific criteria for capabilities, equipment, and more. They can send new trial opportunities directly within PROPEL and receive real-time site responses and turnaround timing metrics in return. 

Today, we partner with many of the industry’s largest site networks to drive efficiency, compliance, and patient engagement. That’s why Devana is humbled to call virtually every major site network a partner-client. In fact, eight of the top 10 site networks in the world have already adopted Devana. The exponential growth of our site network clients spotlights the tangible benefits of leveraging advanced eClinical technology across the entire clinical trials journey.  

Final Thoughts

The momentum behind the site sector consolidation trend is undeniable and continues to gain traction. Whether it’s backing a single large site as a platform investment or spearheading a network roll-up strategy, private equity sponsors are actively seeking opportunities to deploy capital and drive site consolidation efforts.  

At RealTime Software Solutions, our team predicts that the consolidation trend will continue to play out similarly across the site sector as it did from the 1990’s through the early 2020’s in the CRO sector. The site consolidation wave will continue until the site space is largely dominated by only a handful of major global site organizations in much the same manner as just a handful of major global CROs control almost 80% of the pharmaceutical sponsors outsourcing spend on clinical trials that run through CROs. As such, it’s crucial for independent site owners to position themselves as market leaders in their respective fields, recognizing that acquisition by larger networks is inevitable for long-term success. By staying ahead of the curve and strategically investing in growth areas, sites can still emerge as industry leaders. 

Decoding How Sponsors Evaluate Research Sites for Clinical Trials

When selecting clinical research sites for their trials, sponsors look for a blend of capabilities, resources, and a proven track record that promises the best outcomes for their studies. With sponsors seeking top-performing sites that align with their trial objectives, the ability to showcase expertise, efficiency, and reliability is the key component to success. This selection process is crucial as the chosen sites directly impact the efficiency, compliance, and ultimately the outcome of clinical trials.  

In this blog, we’ll explore the key factors that sponsors consider when evaluating potential clinical research sites. From the expertise of the staff and the facility’s infrastructure to patient recruitment strategies and regulatory compliance, understanding what sponsors are looking for can help clinical sites not only meet but exceed these expectations. Whether you’re a seasoned investigator or a site looking to attract more trials, this insight into sponsor priorities will provide valuable guidance on how clinical research sites can use purpose-built technology, like PROPEL, built by Devana Solutions, to demonstrate that they are a high-performing site that stands out in a competitive field. 

Site Experience and Expertise 

One of the primary considerations for sponsors during site selection is experience and expertise. Sponsors prefer sites with a proven track record of successfully conducting similar trials, demonstrated by a history of patient recruitment, retention, and data quality. Additionally, sites and Physician Investigators (PIs) having expertise in specific therapeutic areas or specialized procedures relevant to the trial protocol is also highly valued.   

By centralizing data management, PROPEL is a pioneering platform that enables sites to efficiently track and report on key performance metrics. This consolidation of data within a single system streamlines operations, offering unprecedented visibility into trial progress and site performance. With its powerful analytics and reporting capabilities, PROPEL enables research sites to transparently showcase their past and current performance metrics to sponsors. From patient recruitment statistics in a given indication to site activation timelines, PROPEL generates customizable reports highlighting a site’s efficiency and effectiveness.  With PROPEL, sites can effectively monitor their performance, identify areas for improvement, and demonstrate their capabilities to sponsors with unparalleled precision and efficiency. Sponsors appreciate sites that can provide transparent and timely performance data, as it allows them to make informed decisions when selecting partners for their trials. Moreover, this transparency enhances the site’s reputation and ultimately strengthens the overall partnership between sites and sponsors. 

Patient Population and Recruitment Potential 

Patient retention and recruitment is another pivotal factor for success in clinical trials. Access to diverse patient pools is particularly important. Clinical research sites are assessed by sponsors based on their access to the target patient population and their innovative strategies for patient recruitment. 

In recent years, there has been a growing mandate to improve diversity in clinical trial populations. This push is driven by the recognition that diverse populations may respond differently to treatments, which has significant implications for the generalizability of trial results. In fact, regulatory bodies like the FDA in the United States have issued guidelines that encourage the inclusion of varied demographic groups in clinical trials to ensure that the findings are applicable to a broader population. These guidelines recommend that trial designs consider factors such as age, gender, and racial and ethnic backgrounds. Sites that have established relationships with patient communities often have an advantage. These relationships facilitate trust and communication, which are crucial for encouraging participation and ensuring participants remain engaged throughout the trial.   

Sponsors value sites that can leverage past and real-time data analytics to drive continuous improvement and ensure the success of their trials. PROPEL’s advanced analytics capabilities provide clinical research sites with invaluable insights into trial performance. By analyzing site metrics, patient recruitment trends, and operational efficiency indicators, sites can make data-driven decisions that optimize trial strategies and resource allocation. Additionally, sites can track which patient recruitment methods have worked the best in the past to inform future decisions. Plus, PROPEL’s seamless integrations with the leading CTMS providers allows for a full-cycle view of past trial performance and patient recruitment.  

Site Facility and Resources 

The physical infrastructure and resources available at a site are carefully evaluated by sponsors. This includes the availability of state-of-the-art facilities for patient visits, laboratory capabilities for sample processing, and access to necessary equipment and technology. Adequate staffing, including trained research personnel and support staff, is essential for efficient trial conduct.  

Using comprehensive site profiles, PROPEL makes it easy to see all the key capabilities, equipment, and staff members in one place. For larger site networks, PROPEL enables central teams to query all their sites and filter by specific criteria, including equipment and therapeutic specialties. This makes it easy for research site organizations of all sizes to respond quickly to sponsors about how their available resources match up to the trial opportunity.

Regulatory Compliance and Quality Assurance 

Sponsors are increasingly vigilant about regulatory compliance, given its impact on the integrity and validity of trial results. Sites that can demonstrate that they prioritize and manage regulatory aspects effectively are often more attractive to sponsors. This includes compliance with Good Clinical Practice (GCP) guidelines, adherence to protocol requirements, and timely reporting of adverse events. Sites with robust quality assurance processes and a culture of continuous improvement tend to be favored by sponsors.  

PROPEL simplifies regulatory compliance for sites, offering a comprehensive platform for tracking all necessary regulatory documents. The platform includes automated compliance workflows, which significantly reduces the potential for human error and improves the efficiency of compliance processes. Furthermore, PROPEL provides detailed audit trails for sites to consistently verify and document their compliance status throughout the clinical trial process. Altogether, PROPEL helps sites demonstrate their commitment to maintaining high-quality standards. 

Budget and Contract Negotiation 

While not the sole determining factor, budget considerations play another significant role in site selection. Sponsors evaluate potential sites based on their proposed budgets, which include personnel costs, overhead expenses, and any additional services required. Additionally, a site’s negotiation skills and their ability to offer flexible contract terms can also influence site selection decisions.  

PROPEL further optimizes trial management by centralizing tasks and automating many routine workflows, thereby improving efficiency, reducing the administrative burden, saving time and money, and minimizing errors. The platform’s ability to capture real-time data allows research sites to document these efficiencies and cost savings through detailed reports and key performance indicators (KPIs). This capability helps sites distinguish themselves in a competitive field.  Sponsors are drawn to sites that can demonstrate streamlined operations, as it signifies a commitment to excellence and a focus on delivering high-quality data within stipulated timelines. 

Communication and Collaboration 

Effective communication and collaboration between sponsors and clinical research sites are essential for the smooth conduct of clinical trials. Sponsors further evaluate sites based on their responsiveness, transparency, and willingness to collaborate on trial-related activities. Sites that demonstrate proactive communication and a commitment to addressing sponsor concerns are more likely to be selected as effective collaboration is a cornerstone of successful clinical trials.   

PROPEL is purpose-built to facilitate seamless communication and collaboration among site teams, sponsors, CROs, and other stakeholders. Real-time sharing of information, progress updates, and feedback fosters a collaborative environment that instills confidence in sponsors. Sites that leverage PROPEL to enhance collaboration and data-sharing are more likely to stand out to sponsors seeking reliable partners. 

Stand Out with PROPEL 

Selecting the right clinical research sites is a critical step in the success of clinical trials. Sponsors carefully evaluate sites based on various factors, including experience, patient recruitment potential, facilities, and more. Devana Solutions’ one-of-a-kind PROPEL platform empowers sites to elevate their performance and stand out to sponsors. By streamlining and automating operations, enhancing collaboration, enabling data-driven decision-making, ensuring regulatory compliance, and providing transparent performance metrics, PROPEL equips sites with the tools they need to showcase their expertise and reliability. As sponsors seek out top performing sites to partner with, PROPEL emerges as a key differentiator that enables research sites to shine and win more trial opportunities from sponsors and CROs.  

Devana Solutions  

A RealTime Software Solutions Company, Devana Solutionsis an innovative cloud-based clinical trial software provider that supports real-time collaboration between central research operations professionals and decentralized clinicians serving patients in diverse communities. Devana Solutions even bridges the technology access and data divide by seamlessly and securely connecting decentralized researchers to other mission-critical clinical trials systems.   

Let us show you in more detail what Better Data, Better Decisions, Better Outcomes could do for your clinical trial processes.Book a demo with Devana Solutions today to learn about our cloud-based data analytics clinical trial software for the clinical trials industry that integrates seamlessly with CTMS and other key systems to keep success in the crosshairs.  

Read More: Case Study – Accellacare (ICON’s Global Site Network) & Oncacare (specialized oncology site network) 

Advancing Clinical Trial Site Management: Strategies for Improved Performance

One common frustration in the initiation phase of clinical trials is the frequent occurrence of delays. In an analysis published by Nature, nearly a quarter of all trials experienced setbacks due to strategic issues, commercial barriers, and operational challenges. The financial repercussions of such setbacks are significant, with drug developers facing potential losses ranging from $600,000 to $8 million per day. While this statistic is commonly seen as the cost of doing business, effective site management empowered by the right technology can help save time and money throughout the life of a clinical trial. 

Devana Solutions’ PROPEL platform provides a cutting-edge solution designed to transform site management and empower central and site-based teams alike with tools for accelerating study startup, improving site turnaround times, and more. PROPEL fosters a strong connection between both teams, allowing for interactions during study startup and beyond, from collaborating on contracts and budgets for a given trial to determining equipment needs for upcoming studies. Based on internal analysis, clients have saved up to 14.25 hours per study activation and a 76% reduced contract and budget turnaround time thanks to PROPEL’s unique streamlined workflows and improved trial management tools. 

Establish Centralized Operations 

It is crucial for clinical research sites to have a central and reliable source of information for all aspects of a clinical trial. From study startup to regulatory document management, PROPEL consolidates critical functions into a single, user-friendly platform and serves as the centralized hub and project management tool for both central and site-based teams.  

PROPEL Trial Record.

With consolidated operations, research organizations can more easily develop standardized processes across all sites and teams – saving time and money. PROPEL’s advanced study startup and project management tools allow trials to progress quickly, with automated alerts keeping everyone on task. PROPEL’s comprehensive site and contact profiles also help with site management and oversight, storing all related documents and information for a given site, investigator, office staff member, vendor, and more. Users are notified of expiring certifications and can easily share updates to keep profiles current. 

But PROPEL doesn’t stop at sites and operations teams – it connects every functional group in the organization, including business development, feasibility, finance, regulatory, leadership, and more, – keeping everyone on the same page using a secure, shared platform. This streamlining of operations enhances efficiency, reduces the risk of errors, and ensures that sites can focus on what matters most – helping patients and advancing clinical trials. 

Boost Collaboration 

Effective and timely collaboration is the heartbeat of successful clinical trials. PROPEL facilitates seamless communication among research sites, central team members, leadership, sponsors, CROs, and other stakeholders. Its integrated features such as threaded chat conversations enable real-time sharing of information, documents, progress updates, and feedback – fostering a collaborative environment that accelerates decision-making and enhances the overall efficiency of individual sites. All correspondence is also logged for future reference and reporting.   

When it comes to selecting a site for a trial, PROPEL allows central teams to query all sites in their network, filter key capabilities and equipment, and send opportunities directly within the platform. Sites are notified upon receiving a new trial opportunity, allowing them to review the specifics, determine the best investigator, and instantly provide feedback to central teams – all using the same system. There’s no need to sift through emails or physical files because all the necessary information is located within PROPEL. As sites respond to opportunities, the system tracks all responses and turnaround timing metrics.  

Once a trial begins, research professionals can quickly share protocols, contracts, and other supporting trial documentation and updates with each other, no matter their location. Both site and central team members can also update milestones as trials progress – speeding study startup and improving visibility across the organization. 

Implement Data-Driven Decision-Making 

PROPEL Site Activity Dashboard.

For leadership teams, PROPEL goes beyond simple data management by offering powerful analytic tools. Organizations can leverage PROPEL’s custom dashboards and reports to gain actionable insights into trends such as patient recruitment, site performance, and more. This empowers central team members to make data-driven decisions on the fly, allowing them to react quickly to changes and new information as they optimize resource allocation, improve recruitment strategies, and enhance overall trial outcomes. 

Final Thoughts 

Standing out to CROs and sponsors is a critical feat for sites looking to grow their business and win more trial opportunities. In general, CROs and sponsors are looking for sites and networks with past experience in a given indication, good patient recruitment and retention rates, and overall quick turnaround times. PROPEL helps sites capture this data automatically as trials progress through the systems and displays it in the form of powerful dashboards and reports, making your data easy to share with both internal and external stakeholders. Quickly see which indications you’ve had the most success in, turnaround timing metrics for site activities, and real-time patient enrollment numbers at any time – all evidence for how well your site could perform on a new trial opportunity, giving you better leverage for winning new studies and negotiating terms.  

PROPEL offers a first-of-its-kind solution to mitigate delays, optimize resource allocation, and accelerate the pace of clinical research. A centralized platform strengthens operational excellence across clinical research site organizations to enhance collaboration and empower data-driven insights. PROPEL provides easy access and visibility into trial and site metrics across your network – helping to bridge data gaps, reduce delays, and ultimately, secure and complete more trial opportunities. 

Devana Solutions  

A RealTime Software Solutions Company, Devana Solutionsis an innovative cloud-based clinical trial software provider that supports real-time collaboration between central research operations professionals and decentralized clinicians serving patients in diverse communities. Devana Solutions even bridges the technology access and data divide by seamlessly and securely connecting decentralized researchers to other mission-critical clinical trial systems.   

Let us show you in more detail what Better Data, Better Decisions, Better Outcomes could do for your clinical trial processes.Book a demo with Devana Solutions today to learn about our cloud-based data analytics clinical trial software for the clinical trials industry that integrates seamlessly with CTMS and other key systems to keep success in the crosshairs.  

Transitioning from Paper to Electronic Workflows in Clinical Trials with PROPEL

Clinical trials play a pivotal role in advancing medical research and bringing new treatments to patients. Traditionally, trials have been conducted using paper-based methods for startup activities and beyond, such as negotiating Confidentiality Disclosure Agreements (CDAs) and managing regulatory processes, but the landscape is rapidly evolving. In recent years, there has been a growing momentum towards digitizing and modernizing clinical trials overall – including electronic documents.  

Embracing electronic documents and tools such as Devana Solutions’ category-defining PROPEL platform can help increase an organization’s efficiency, accuracy, compliance, and more throughout the entire clinical trial process. PROPEL is a business process improvement platform that touches all things clinical trials – from pipeline management and streamlined study startup through to historical trial metrics – including document management, providing one source of truth for all your clinical trial data that can be easily shared with internal and external shareholders alike.  

Why Transition 

There are many compelling reasons as to why the clinical trials industry should consider moving away from paper and embracing digital solutions, including: 

  1. Efficiency and Speed: One of the primary advantages of transitioning to digital platforms and electronic documents is the significant improvement in efficiency and speed. Paper-based processes are inherently slow and prone to errors, leading to delays in data collection and analysis. PROPEL enables real-time data entry, instant updates, automatic alerts and reminders, and streamlined communication among stakeholders, reducing the overall duration of clinical trials. 
  2. Data Accuracy and Quality: Accuracy and quality of data are paramount in clinical trials. Paper-based methods are susceptible to transcription errors, missing data, and inconsistencies. PROPEL offers built-in validation checks, automated data entry, and centralized databases that enhance the accuracy and integrity of trial data. This not only ensures reliable results but also contributes to more robust regulatory submissions. 
  3. Cost Savings: While there may be initial costs associated with implementing digital solutions, the long-term benefits often outweigh them. PROPEL eliminates the need for paper storage, duplicate data entry, and extensive monitoring efforts, leading to substantial cost savings over the course of a clinical trial. All trial-related data and files are stored in a single, secure place, saving time and money when it comes to making changes, sharing updates, searching for historical information, and more. 
  4. Regulatory Compliance: The regulatory landscape governing clinical trials is evolving, and regulatory agencies are increasingly recognizing the benefits of digital solutions. When progressing trials through the startup process and beyond, PROPEL helps to track all regulatory stages, ensuring research site organizations stay prepared for regulatory expectations, contributing to smoother interactions with health authorities. 
  5. Flexibility and Adaptability: Digital platforms provide the flexibility to adapt to evolving trial requirements and protocol changes. Unlike paper, which can be rigid and difficult to modify, PROPEL allows for quick updates and amendments. This adaptability is crucial in the dynamic landscape of clinical research, where trial protocols may need adjustments based on emerging data or regulatory feedback. 
  6. Scalability: As operations grow and expand, having digitized document management is key. Whether you’re looking to add a new investigator or an entirely new site, onboarding is made faster and easier with agile technology. PROPEL enables users to securely share documents between stakeholders regardless of their physical location, helps establish standardized processes across different locations for improved efficiency, and allows central teams to monitor real-time activities across all sites. 

Make the Leap 

The shift from paper to digital in clinical trials represents a transformative leap towards a more efficient, accurate, and adaptable approach to medical research. While challenges and barriers may exist, the benefits of adopting digital solutions like PROPEL far outweigh the status quo. Embracing the future of clinical trials means embracing technology that can revolutionize the way we bring new therapies to patients, ultimately improving healthcare outcomes for all. 

Devana Solutions  

A RealTime Software Solutions Company, Devana Solutionsis an innovative cloud-based clinical trial software provider that supports real-time collaboration between central research operations professionals and decentralized clinicians serving patients in diverse communities. Devana Solutions even bridges the technology access and data divide by seamlessly and securely connecting decentralized researchers to other mission-critical clinical trials systems.  

Let us show you in more detail what Better Data, Better Decisions, Better Outcomes could do for your clinical trial processes.Book a demo with Devana Solutions today to learn about our cloud-based data analytics clinical trial software for the clinical trials industry that integrates seamlessly with CTMS and other key systems to keep success in the crosshairs.  

Why Your Clinical Research Site Needs More Than a CTMS

Clinical trials require precise management across various domains such as patient recruitment, data collection, regulatory compliance, and stakeholder communication. While Clinical Trial Management Systems (CTMS) have been pivotal in organizing and simplifying many of these aspects for clinical research sites, the complexity of modern clinical research often necessitates a broader array of solutions.  

CTMS platforms are instrumental in managing the logistics of clinical trials. Its primary functions include organizing and tracking study milestones, managing patient recruitment and data, ensuring compliance with regulatory standards, and handling site management and financial aspects of the trials. These systems are crucial for maintaining an organized workflow and ensuring that all trial aspects are conducted according to protocol and within regulatory bounds. However, the landscape of clinical research is continuously evolving, driven by technological advancements, increasing data volumes, and more stringent regulatory requirements. As a result, clinical trials are becoming more complex and diversified, often involving multifaceted data sources, varying patient demographics, and innovative study designs. Accordingly, relying solely on CTMS may fall short of meeting the diverse and expanding needs of modern trials.  

Beyond enrollment and the more limited scope of a CTMS, Devana Solutions’ PROPEL cloud-based platform expands the power of your data and trial administration. From pipeline management and pre-award milestones through to trial completion, PROPEL enables you to standardize, streamline, and automate all of your clinical trial processes. 

Enhanced Data Analytics 

PROPEL indications dashboard

PROPEL Indications Dashboard.

Clinical trials generate vast amounts of data, and leveraging this data effectively can be a game-changer. While a CTMS is proficient at managing enrollment and select operational data, PROPEL adds a layer of advanced analytic capabilities on top. PROPEL’s seamless integrations with the leading CTMS providers eliminate duplicate data entry and offer more robust reporting. See all your data for the entire clinical trial process in one place. From opportunities still in the pipeline to trials in pre- and post-award stages, easily break down your data by trial, site, indication, sponsor, and more – all in real time. 

In combining PROPEL’s analytics with a CTMS, research organizations gain valuable insights into site and overall performance, allowing for data-driven decisions that optimize trial design, recruitment strategies, and resource allocation. Plus, PROPEL’s powerful collaboration features allow you to seamlessly incorporate site feedback and updates into decisions, ultimately improving overall patient experience and trial outcomes. 

Adaptive Trial Management 

In clinical trial management, there is an increasing focus on adaptive trial designs and real-time adjustments. An adaptive design adds flexibility, allowing for certain modifications to be made after a trial is underway. The FDA released guidance on such trial designs in 2019. PROPEL’s agile project management tools and focus on site engagement complement a CTMS by providing a dynamic approach to trial management. With automated study startup workflows, PROPEL allows organizations to standardize and accelerate processes – saving time and money while also providing full visibility into current and next steps.  

Once a trial begins at a site, tracking progress and staying in touch is made easier with PROPEL – allowing both sides to update milestones, share key documents, and respond to questions. As a trial moves through the system, PROPEL captures turnaround timing metrics and performance insights which can be used to identify patterns and make quick adjustments on the fly.  

By integrating PROPEL with a CTMS and empowering sites, research organizations can adapt to emerging challenges, optimize resources, and make informed decisions on site selection and management, ensuring the success of adaptive trial designs. 

Beyond CTMS 

While a CTMS remains an indispensable tool for managing the operational aspects of clinical trials, its potential is maximized when integrated with complementary solutions like PROPEL. Working together, your CTMS and PROPEL provide a holistic view of your entire clinical trial process from start to finish. Manage trials, contacts, documents, and more – all in one place. And PROPEL’s open API also allows you to integrate other tools your team uses such as Outlook, Pardot, and beyond to help manage your customers and win future awards.  

An approach that combines patient-centric technologies, data analytics, regulatory compliance tools, and adaptive trial management systems empowers researchers to navigate the complexities of modern clinical research successfully. By embracing a comprehensive ecosystem of integrated solutions, the clinical trial community can enhance efficiency, improve patient outcomes, and accelerate the development of innovative treatments. 

Devana Solutions 

A RealTime Software Solutions Company, Devana Solutionsis an innovative cloud-based clinical trial software provider that supports real-time collaboration between central research operations professionals and decentralized clinicians serving patients in diverse communities. Devana Solutions even bridges the technology access and data divide by seamlessly and securely connecting decentralized researchers to other mission-critical clinical trials systems.  

Let us show you in more detail what Better Data, Better Decisions, Better Outcomes could do for your clinical trial processes.Book a demo with Devana Solutions today to learn about our cloud-based data analytics clinical trial software for the clinical trials industry that integrates seamlessly with CTMS and other key systems to keep success in the crosshairs.  

2023 Year in Review

As December winds down, we can officially say that 2023 has been a year of transformative growth and innovation at Devana Solutions! We’ve seen major updates and enhancements in our product offerings, and experienced exciting developments in our business structure. 2023 has been a landmark year, setting new milestones and paving the way for even greater successes to come. 

Products 

This year, we made a dedicated effort to bring several new interface and usability updates across PROPEL and LYNK. Our category-defining software is now more user-friendly and accessible than ever! 

Some of the exciting new features released this year include: 

  • Surveys 
  • Notes 
  • Revenue forecasting 
  • Trial management hub 

 In addition to these new items, we also enhanced several existing features and functions of the platform such as trial tracking, document management, historical enrollment metrics, and more. We plan to continue bringing even more features and refinements to PROPEL and LYNK in the future, so look forward to regular updates throughout 2024. 

Client-Partners 

Customer satisfaction is core to our mission, and we are committed to providing the best-in-class customer experiences. This year, Devana welcomed many new partner-clients to the platform while also experiencing steady growth with existing customers. We are proud to support our partner-clients as they continue to grow and expand their business and site networks across the industry. Such aggressive, sustained growth is only possible with a powerful platform like PROPEL, which provides comprehensive trial management and data analytics for site organizations of all shapes and sizes. We are honored to support them in our shared mission of bringing new and better therapies to patients all over the world.  

Giving Back 

Alongside our continued partnerships with clients, Devana is also pleased to have continued our support of Greater Gift in 2023. As part of their mission to increase awareness of clinical trials and celebrate those who participate in them, Greater Gift works with other non-profit organizations to pay forward the contributions of individuals involved with clinical research to children in need. This year, Devana ramped up our support of Greater Gift with a new process of making a donation for each new client who completes onboarding with PROPEL. With this method, we now support Greater Gift all year long in addition to our annual donation around the holidays honoring of all our current partner-clients. 

Strategic Partnerships 

Last, but certainly not least, we want to highlight our partnership evolution with RealTime Software Solutions. Since Devana’s acquisition by RealTime in July, both companies have been hard at work integrating our teams, products, and services. Our companies are aligned in our commitment to customer service and innovation. We are dedicated to delivering powerful solutions that empower the clinical research industry and further streamline the development of life-changing treatments. We’re thrilled to set a new standard for end-to-end site platforms.  

What Lies Ahead 

As we close the chapter on an extraordinary 2023 and look ahead to 2024, we’re filled with anticipation for the continued evolution of our services, products, and partnerships, all aimed at empowering the clinical research industry. Thank you for being a part of our 2023 journey. Here’s to a new year filled with more milestones, achievements, and shared successes! 

Devana Solutions  

Devana Solutions is an innovative cloud-based clinical trial software company that supports real-time collaboration between central research operations professionals and decentralized clinicians serving patients in diverse communities. Devana Solutions even bridges the technology access and data divide by seamlessly and securely connecting decentralized researchers to other mission-critical clinical trials systems.  

Let us show you in more detail what Better Data, Better Decisions, Better Outcomes could do for your clinical trial processes. Book a demo with Devana Solutions today to learn about our cloud-based data analytics clinical trial software for the clinical trials industry that integrates seamlessly with CTMS and other key systems to keep success in the crosshairs.  

Expedite Your Study Startup – A Site Checklist

Study startup and site activation are key to the clinical trial process, but often suffer from delays. It can be a time-consuming undertaking and requires multiple teams and moving parts to successfully begin a trial at the best sites for the protocol. In fact, a recent ACRP survey revealed that study startup was ranked among the top challenges facing clinical research sites. 

While sponsors handle much of the initial study startup process such as protocol development, PROPEL is designed to help site organizations accelerate the aspects that they control. Custom-made for clinical trials, PROPEL offers study startup automation and organized workflows to accelerate the clinical trial process for sites and site networks.  

Sites that have adopted PROPEL see almost 15 hours of time saved per study activation and 40% increased revenue. To assist sites and site networks in meeting targets, we’ve prepared a checklist that simplifies each step with tips to reduce potential delays and accelerate the study startup process. 

Fast-Track Study Startup

PROPEL manages and optimizes every part of the site side of study startup. And with PROPEL, unlike paper or a CTMS, both pre- and post-award milestones can be tracked in the system by central teams or individual sites as trials progress.  

1. Site Selection

Successful trials depend on sourcing the right-fit sites for study opportunities. Sponsors prioritize the identification of site locations with abundant resources, including staff expertise, facilities, and accessibility to the target subject population. 

PRO TIP: To eliminate time spent on identifying sites with the relevant experience and resources, PROPEL’s query feature limits your search to only those sites matching the trial’s specific qualifications and capabilities. Opportunities and site responses are also centralized and tracked all in a single platform, simplifying oversight. 

2. Confidential Disclosure Agreements (CDA)

CDAs are essential to ensuring the protection of sensitive information shared during the early stage of a clinical trial. A sponsor may choose to forward a protocol to the Principal Investigator (PI) for their consideration regarding trial participation. To protect confidential information within the protocol, the sponsor may issue a CDA.  

PRO TIP: Using PROPEL, sites can organize CDAs by attaching them directly to a trial. This allows for easy access and reference. With the inclusion of Master CDAs by the sponsor or CRO, the process becomes even more efficient, enabling quick retrieval and comparison of key information.  

PROPEL also tracks CDA status and completion by site, providing a comprehensive overview of the progress at each research site. This capability allows for effective monitoring of the CDA execution process, ensuring that all necessary parties have completed the required steps.   

3. Feasibility

Sites are tasked with filling out and returning site feasibility questionnaires to aid in the selection process and uncover potential participation opportunities in new studies.  

PRO TIP: PROPEL organizes this process by directly linking feasibility questionnaires to a trial and tracking completion by site. And with PROPEL’s Survey Feature, central teams can also create their own custom surveys and questionnaires, from feasibility and CSAT, to PI onboarding and equipment management. Surveys can be as general or specific as you want and for just about any use case.  

4. Pre-Selection Visit (PSV)

A PSV is a meeting with a sponsor representative to assess if your site is capable and equipped to conduct a specific trial. During this critical step, sites that do not meet the necessary requirements for conducting the trial will be excluded.  

PRO TIP: PROPEL enables sites to monitor PSV progress from requested to completed. For transparency and increased collaboration, users can share updates or missing items with the broader team for more support.  

5. Award Letter

The next stage in the startup process centers around managing awards, particularly if you’re running a site network. An award letter triggers another series of intricate processes that includes reviewing or establishing accounts and providing documentation of deliverables stipulated in award documents.   

PRO TIP: PROPEL uniquely streamlines this process, organizing which sites have been green lit for a study, and which are still working through pre-award milestones.    

6. Contracts & Budgets

Contracts and budgets must be established prior to the initiation of a study at your clinical research site. Beyond managing the various contracts, including CDAs and Clinical Trial Agreements (CTAs), sites are tasked with developing a comprehensive budget outlining all expenses related to conducting a clinical trial. These tasks ensure compliance with regulatory requirements and promote responsible fiscal management for both the PI and the site.  

PRO TIP: Rather than relying on traditional methods for managing this task, PROPEL is an innovative task manager that tracks the contract and budget progress, uploads relevant documents, and communicates updates and revisions. Leveraging PROPEL, sites can experience a reduction of up to 76% in contract and budget turnaround time.   

7. Regulatory

Gathering and sharing essential documents during study startup is another stage where teams commonly face challenges that slow down the process.  

PRO TIP: PROPEL effectively manages crucial regulatory milestones including Institutional Review Board (IRB) submissions, Informed Consent Form (ICF) preparations, and Site Initiation Visit (SIV) arrangements.  

With PROPEL, sites can track completion dates for each milestone, allowing for a clear overview of progress and ensuring timely follow-ups when necessary. Sites can seamlessly upload and organize pertinent documents, creating a centralized repository that simplifies accessibility and enhances regulatory compliance. The system also facilitates seamless communication and collaboration through chat conversation threads that enable efficient information sharing. 

Optimize Operations

PROPEL Enrollment Dashboard.

Once study startup is complete and the trial begins running at a site, PROPEL’s seamless integrations with leading CTMS such as RealTime, CRIO, and Clinical Conductor take over to track patient recruitment and enrollment. After the trial is completed, PROPEL further provides holistic trial performance metrics for site activities, enrollment, indications, and more.   

With full oversight into real-time trial milestones and site activity, central teams can leverage key startup metrics and trial performance reports to identify bottlenecks – allowing them to quickly act to help struggling sites.    

Key Benefits: 

  • Consolidate all your trial data, documents, and communication in one place. 
  • Keep central team members and site-based staff on the same page with powerful collaboration tools, eliminating needless emails, phone calls, and meetings inquiring about trial stages or updates.  
  • Centralize oversight of how trials are progressing.  
  • Share documents, tag users, and set custom alerts and reminders to keep tasks on track.  
  • By eliminating repetitive tasks and accelerating standard workflows with PROPEL, staff can spend more time on specialized tasks and patient-centric duties. Discover why the industry’s leading site networks have already adopted PROPEL. Startup up more studies faster and become a more competitive site organization with PROPEL.  

Devana Solutions  

Devana Solutions is an innovative cloud-based clinical trial software company that supports real-time collaboration between central research operations professionals and decentralized clinicians serving patients in diverse communities. Devana Solutions even bridges the technology access and data divide by seamlessly and securely connecting decentralized researchers to other mission-critical clinical trials systems.   

Let us show you in more detail what Better Data, Better Decisions, Better Outcomes could do for your clinical trial processes. Book a demo with Devana Solutions today to learn about our cloud-based data analytics clinical trial software for the clinical trials industry that integrates seamlessly with CTMS and other key systems to keep success in the crosshairs.  

Speed Up Your Research Site Organization’s Turnaround Times 

Regardless of size and type, clinical research site organizations compete for trial opportunities from CROs and sponsors. There are many factors that can make a site stand out amongst the crowd, but turnaround times for key items may be one of the larger deciding factors. CROs and sponsors want to get trials up and running as quickly as possible and demonstrating that your organization has a history of turning things around quickly can make you stand out.

Designed specifically for the clinical trial industry, PROPEL accelerates workflows and automatically captures and records turnaround timing and performance metrics along the way.

Accelerated Workflows 

Speed matters in clinical trials. That’s why PROPEL accelerates every step of the clinical trial process – from pipeline management to study startup and beyond. Optimize execution with standardized processes that offer full visibility into current and next steps across your organization, saving time and reducing the risk of things slipping through the cracks or getting delayed.  

Once a trial begins enrollment, it’s hard to speed things up. That’s why it’s important to accelerate those tasks which can be sped up, saving time and manpower for other critical areas of focus such as patient recruitment and enrollment. Designed to streamline every process possible, PROPEL eliminates many repetitive tasks, including data entry into a myriad of systems or sending countless emails to update sites. Instead, PROPEL’s seamless integrations allow you to enter data only once, while real-time collaboration tools foster easy communication with sites. Tracking trial milestones is also made easier, allowing sites and central teams alike to update progress, share key documents, and alert others to any roadblocks or questions.  

And, as trials move through the system, PROPEL automatically tracks turnaround times for activities such as business development, study startup, site-based milestones, and moreallowing you to see patterns and make informed decisions.  

Process and Performance Transparency 

PROPEL Site Activity Dashboard 

Data transparency is critical to effective clinical trial management. PROPEL was engineered with proprietary algorithms that automatically capture hundreds of process and performance metrics by indication, site, PI, trial, and more. In fact, every data point within PROPEL is reportable – allowing users to create custom dashboards and reports to analyze and share with key stakeholders.  

PROPEL’s cloud-based platform allows central teams to collaborate with site-based study teams in real time. Gain insight into your entire organization’s trial process and data from start to finish as it happens, allowing you to drive buy-in and accountability across the board. Effortlessly monitor the latest metrics on trial status, site activity, patient enrollment, and more – allowing central team members to take swift action based on the most up-to-date site activities and enrollment data, leading to faster decision-making and improved trial outcomes. This data can then improve the overall trial process by matching the right sites and investigators with the trials that best suit their capabilities and location. Once the proper teams are aligned, you’ll experience an increase in trial performance, reducing cycle times and allowing you to better predict future performance. 

Improve turnaround times and stand out to CROs and sponsors with PROPEL’s powerful workflow improvements and data analytics. Easily show both real-time and historic reports based on site activity, enrollment, indications, and more – helping win more trials that suit your organization’s strengths.  

Devana Solutions  

Devana Solutions is an innovative cloud-based clinical trial software company that supports real-time collaboration between central research operations professionals and decentralized clinicians serving patients in diverse communities. Devana Solutions even bridges the technology access and data divide by seamlessly and securely connecting decentralized researchers to other mission-critical clinical trials systems.  

Let us show you in more detail what Better Data, Better Decisions, Better Outcomes could do for your clinical trial processes. Book a demo with Devana Solutions today to learn about our cloud-based data analytics clinical trial software for the clinical trials industry that integrates seamlessly with CTMS and other key systems to keep success in the crosshairs.  

2023 SCRS Global Site Solutions Summit: Forging Stronger Sites

The SCRS Global Site Solutions Summit is almost upon us. By design, the Summit aims to help make sites of all sizes and structures more competitive and successful. This year, topics range from strategies for improving retention rates, to contract and budget help. As a Premier Sponsor of the Summit, Devana Solutions is proud to be part of these annual discussions around expanding site capabilities and resources.  

Become a More Competitive Site

Want your site organization to stand out more during feasibility? Be sure to attend Breakout Session IV: How to Stand Out as a Site and Be Selected for Studies on Saturday, October 7 at 4:15pm. 

Join Devana Solutions’ CEO and Co-Founder Barry Lake as he facilitates a panel of successful sites and sponsors as they discuss how to become a partner site of choice. Understand the key elements of the study startup process and get tips and metrics from sponsors and CROs to help improve your site’s visibility. Featured panelists include Jillian Agnew, Senior Clinical Research Nurse, St. Johns Center for Clinical Research, Karen McIntyre, Global Site Alliances, Parexel, Lindsey Morales, Associate Director of Clinical Operations, Gilead, and Karen Pypniowski, Vice President of Feasibility & Site Operations, Circuit Clinical. 

And don’t forget to visit Team Devana at Booth 507 in the Expo Hall for a demo of PROPEL, our comprehensive clinical trial data management software. Let us show you how workflow automation and advanced data analytics can transform your organization’s clinical trial process end-to-end and give you a leading edge on winning trial opportunities.  

Devana Solutions

Devana Solutions is an innovative cloud-based clinical trial software company that supports real-time collaboration between central research operations professionals and decentralized clinicians serving patients in diverse communities. Our platform bridges the technology access and data divide by seamlessly and securely connecting decentralized researchers to other mission-critical clinical trial systems. 

Let us show you in more detail what Better Data, Better Decisions, and Better Outcomes could do for your clinical trial processes. Book a demo with Devana Solutions today to learn about our cloud-based data analytics clinical trial software for the clinical trials industry that integrates seamlessly with CTMS and other key systems to keep success in the crosshairs. 

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