decentralized clinical trials Archives

Why Your Clinical Research Site Needs More Than a CTMS

January 17, 2024 by Devana Solutions

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.

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 Solutions is 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. 

PROPEL

Expedite Your Study Startup – A Site Checklist

November 16, 2023 by Devana Solutions

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. 

PROPEL

Speed Up Your Research Site Organization’s Turnaround Times 

November 2, 2023 by Devana Solutions

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 more – allowing 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 

PROPEL

New PROPEL Survey Feature

August 11, 2023 by Devana Solutions

In the fast-paced world of clinical trials, feasibility surveys have become a crucial step in the process. These surveys help researchers determine the viability of their trials and ensure that all the necessary resources and capabilities are in place. However, it is important to recognize that surveys have the potential to be powerful tools in various other aspects of clinical research. Building relationships, understanding site capabilities, and gathering feedback are just a few of the areas where surveys can prove to be invaluable.

Surveys are an incredibly powerful tool, allowing researchers to collect feedback and insights from a wide range of recipients. Whether it’s gathering information from sites within your network, potential vendors, patients, or investigators, surveys can provide valuable data that can inform important decisions.

PROPEL Enterprise’s new Survey Feature is an exciting development for the clinical trial industry. With this innovative tool, researchers can create and distribute surveys directly within the platform, reaching a large audience and gaining valuable data in a streamlined and efficient manner.

How It Works

PROPEL Enterprise‘s new Survey Feature functionality (GIF).

Quickly create and send surveys directly within PROPEL to LYNK users or external email lists. Use pre-built templates, import existing questions, or create a survey from scratch with PROPEL’s easy-to-use interface. For ease of tracking, you can also associate your survey with a specific trial, contact, or account.

Once a survey is sent, PROPEL will automatically collect all timing and response data in one place for easy monitoring and reporting – giving you real-time visibility into who has completed a survey, who hasn’t, and who stopped part-way through. But the feature doesn’t stop there – eliminate endless follow-up emails with automated alerts and reminders.

Instead of relying on multiple programs and websites to send and track surveys, PROPEL provides a closed-loop system allowing you to make surveys, send them out, and to get in-depth analytics on responses and timing.

For Any Kind of Survey

Survey Feature interface.

PROPEL’s new feature aims to transform and streamline the survey process – from feasibility and CSAT to PI onboarding, equipment management, and beyond! Surveys can be as general or specific as you want and for any use case under the sun. Want to know what kind of studies sites are looking for? Need to follow-up with a site or PI about a recent onboarding? PROPEL’s new Survey Feature is here to help!

Ready to see how Devana Solutions continues to revolutionize how clinical research professionals gather and analyze feedback? Schedule a demo today!

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 bridges the technology access and data divide by seamlessly and securely connecting decentralized researchers to other mission-critical clinical trials systems. 

PROPEL

PROPEL Spring ’23 Update

May 26, 2023 by Devana Solutions

Get ready for an exhilarating update to PROPEL! The Spring ’23 Update brings a plethora of enhancements, refinements, and additions to the platform designed to improve and streamline the user experience system wide with a heavy focus on Trials and Trial Management.

PROPEL’s latest release is all about optimizing glanceability and improving workflows while prioritizing the information that means the most, from harmonized field names to a new glossary for credentials and the release of Trialstones. The theme underlining the entire release can be summed up as “Trials” – which have been given a complete makeover, including new Trialstones, streamlined tabs and fields, and a progress bar to keep track of trial status.

What’s New?

The user interface (UI) has been updated and enhanced across several areas of the platform so everything can be quickly absorbed at a glance. A key part of the updated UI is the new progress bar, which clearly shows what stage a trial is currently in. New, more visually compelling monitoring tiles have replaced checklists in various places, making content more scannable and insights digestible. See below for a look at the new real-time progress bar and pre-award Trialstones tiles.

PROPEL Trial page with new progress bar and pre-award Trialstones.

What’s a Trialstone, you ask? Pre- and post-award trial milestones are now known as Trialstones throughout the platform. When sites complete Trialstones such as CDA Executed or PSV Complete, this information will be updated across the system – including advancing the trial stage in the new progress bar. Users can track and manage Trialstones directly from any trial page within PROPEL for improved workflows. With the new update, Trialstones can also be updated for multiple sites at once to save time.

Another great new feature coming in this update is that trials can now be marked as high priority. Making a trial high priority adds a red star to the list view, clearly calling out trials which have been flagged. This new feature allows central team users to delineate which opportunities and trials sites should focus on first.

We’ve only covered some of the broader highlights, but the Spring 2023 Update brings a lot of exciting new quality of life changes to PROPEL and LYNK. Full release notes and training materials have already been made available to our existing partner-clients. If you’re interested in learning more, please contact us today and we’d be happy to give you a demo of our game-changing platform.

Devana’s product development pipeline has more exciting updates and features coming soon, so stay tuned! 

Devana Solutions 

Clinical Trials | PROPEL

Effectively Manage Decentralized Sites with Clinical Trial Software

June 23, 2022 by Devana Solutions

Since the beginning of the COVID-19 pandemic, more and more organizations have been exploring the possibilities of decentralized clinical trials (DCTs). Decentralized trials have many benefits, including accelerated patient access, improved patient engagement and retention, and increased diversity. Unfortunately, these benefits also come with challenges such as reduced collaboration and limited data access.

Clinical trial software such as Devana Solutions PROPEL can help central research operations connect to decentralized site staff during study startup through trial completion, regardless of site location.

Increase Collaboration, Data-Sharing, and Visibility Across DCTs

Devana Solution’s cloud-based software seamlessly and securely connects central research sites, CROs, Sponsors, and decentralized sites, facilitating real-time collaboration and sharing of data. Our solutions allow research operations professionals to share protocols, contracts, budgets, and other supporting trial documentation with decentralized sites, speeding study startup and improving visibility across the trial’s network.

Forget managing cumbersome emails, phone calls, and lengthy meetings—central teams can communicate directly to sites within PROPEL, and all correspondence is logged for future reference. Sites can also update their key milestones via our LYNK interface, ensuring the central team is always aware of the status of the trial. Central research teams can even assign tasks to sites and view what has been completed and remains outstanding.

Instead of manually searching for opportunities or site-specific details, PROPEL allows users to query all sites, filter key data, and collate opportunities. Customizable dashboards and reports provide real-time visibility and help centralized and site-based decision-makers gain actionable insights. The Devana Solutions platform can connect every functional group in a network’s entire organization, from business development and regulatory to finance and leadership.

By leveraging the cloud to connect central teams with site-based clinicians and staff for real-time collaboration, PROPEL provides easy access and visibility to trial, site, user, and contact data across your network—helping to bridge data gaps, secure more trial opportunities, hit more targets, and win more awards.

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.

Events | Partner Spotlight

Devana Solutions Joins Global Leader in Blood Cancer Fight

February 8, 2022 by Devana Solutions

Devana Solutions is proud to announce their sponsorship of Team Raise Hope Together, formed by Grace and Jack Sherner, as part of the Leukemia & Lymphoma Society Students of the Year program. Students of the Year is a philanthropic leadership development program for exemplary high school students that fosters professional skills such as entrepreneurship, marketing, and project management. The students involved in this campaign raise funds for The Leukemia & Lymphoma Society, the world’s largest nonprofit fighting blood cancer.

The Sherners, along with their friend Theo Weiman, formed Team Raise Hope Together in honor of their children’s grandfather, Larry Thayer, who was diagnosed with CLL (Chronic Lymphocytic Leukemia) in 2007.

In April of this past year, their children’s aunt, Betsy, found a tumor on her left breast. Days later, she received a breast cancer diagnosis. In the months since, she has undergone a double mastectomy and a complete hysterectomy.

Devana Solutions is joining to be a part of the generation that puts an end to cancer and provides a monumental impact in the fight.

Devana Solutions’ CEO and Co-founder Barry Lake comments on the effort, “We are proud to support Leukemia & Lymphoma Society and the Students of the Year program. We strive to offer solutions to those committed to the fight against cancer, helping those researchers on the frontline close the gap in eliminating cancer by cutting time and costs in the drug development process. One day, we will defeat cancer!”

The Leukemia & Lymphoma Society is on a mission to cure leukemia, lymphoma, Hodgkin’s disease and myeloma and improve the quality of life for patients and their families. Since 1949, the Leukemia & Lymphoma Society has invested more than $1.5 billion in research to advance therapies and save lives. Today, blood cancer patients live longer because of these advancements made possible by the Leukemia & Lymphoma Society.

The family remains committed to defeating their diagnoses. “I continue to work on my personal recovery, which requires piecing together a new body, mind, and spirit,” their Aunt Betty said.

Join Devana Solutions before March 12 with your donation to Team Raise Hope Together.

Why Your Clinical Research Site Needs More Than a CTMS

Enhanced Data Analytics

Adaptive Trial Management

Beyond CTMS

Devana Solutions

Expedite Your Study Startup – A Site Checklist