Devana Solutions December 2021 Newsletter

 



Wishing You a Wonderful Holiday and a Happy New Year

 

We’d like to extend a warm holiday greeting to all of our client-partners, friends, and supporters. Our industry has faced unprecedented times in these last two years, and the decentralized clinical trial world has emerged stronger, smarter, and more connected. We value being a part of that connectivity.



Give Back with Greater Gift & Honor Clinical Trial Patients

 

At the core of Devana Solutions’ mission—to connect central research operations teams to decentralized clinicians serving patients in diverse community settings—is the goal of reducing drug development costs and curing disease.

That’s why Devana partners with Greater Gift, a 501 (c)(3) non-profit organization that “honors patient volunteers and research professionals who make clinical trials possible,” by helping the public “understand the powerful role clinical trial volunteers play in the development of new drug therapies, medicines, and vaccines.”

Dedicated to combating the data gaps and inequity resulting from many ethnic, racial, and other demographic groups being underrepresented in clinical research, Greater Gift has donated more than 120,000 vaccines—and meals—to children in need since 2010.

Join Devana this holiday season in honoring clinical trial patients by donating vaccines to children in need through Greater Gift.

Learn More and Join Devana in Donating Vaccines


PROPEL Innovates the Clinical Trial Industry in 2021

 

At Devana Solutions, we are continuously innovating to meet the needs of the clinical trials industry. 2021 was the year of “decentralized trials,” as such, the Devana Solutions’ team developed our PROPEL technology solution to connect centralized research operations teams with decentralized clinicians, bringing the “site” to the patient’s community.

 

In a world in which the swiftness to find cures and treatments is as crucial as ever, the Devana team was very humbled, yet not surprised, by the adoption of this latest innovative platform by leading research organizations and especially salute the earliest adopters, including hyperCORE International, Velocity Clinical Research, Inc. and WCG PharmaSeek.

 

Stayed tuned as we head into 2022 since the Devana team is currently onboarding other major research organizations onto PROPEL in both the site network and IRO space but academic and health systems, as well. We are looking forward to an efficient and well-connected New Year for the clinical trials industry to keep speeding new therapies to patients!

Learn more About PROPEL


Operation Warp Speed – The New Standard for Clinical Trials

 

Operation Warp Speed proved that an accelerated timeline was possible with an unprecedented level of process and performance transparency as well as cooperation between drug developers in the clinical trials industry and government.

 

But what factors enabled this never-before-seen public/private cooperation to achieve the impossible, and how could those factors be standardized for future clinical trials in order to compress development cycle time and achieve faster breakthroughs in our most serious diseases?

 

Devana CEO and Co-Founder Barry Lake shares his thoughts.

Read Barry’s Insights


2022 SCRS Oncology Site Solutions Summit

 

As we head into 2022, one of the first major events taking place in the clinical trial industry is the SCRS Oncology Global Site Solutions Summit.

 

Devana CEO and Co-Founder Barry Lake and Director of Client Partnerships Emily Hardy will be walking the Summit?  If you’ve never been, we break down what to expect.

Learn About the Summit

Learn More About Devana Solutions Clinical Trial Data Platform

How Technology Simplifies Clinical Trial Feasibility Assessments

Ah, the dreaded site assessment and feasibility: pages upon pages of requests for information. From equipment specifications to investigator experience to patient population, the amount of data needed to execute a clinical trial feasibility is onerous. You may have most of this information on hand—across a variety of spreadsheets, emails, documents—and in your head. But there may also be gaps in the information you have access to, leaving you no option but to put down your best guess and muddle through.

See How You Can Easily Close Those Gaps
Recent Articles
 

Transform Your Clinical Trial Processes in 2022

 

While those of us who work in the clinical trial space have always known that the importance of our work cannot be overstated, there’s no question that the COVID-19 pandemic has driven home the importance of the clinical trials industry to the rest of the world as well.
Read More
 

Better Manage Your Clinical Trial Operations

 

One of the biggest challenges that clinical research organizations face is managing their vast influx of clinical trial opportunities from Sponsors, CROs and other potential sources. As anyone in this industry knows, there’s a lot of effort that goes into starting up a clinical trial; from sourcing the trial.
Read More

Give Back with Greater Gift & Honor Clinical Trial Patients

At the core of Devana Solutions’ mission—to connect central research operations teams to decentralized clinicians serving patients in diverse community settings—is the goal of reducing drug development costs and curing disease. That’s why Devana partners with Greater Gift, a 501 (c)(3) non-profit organization that “honors patient volunteers and research professionals who make clinical trials possible,” by helping the public “understand the powerful role clinical trial volunteers play in the development of new drug therapies, medicines, and vaccines.”

Dedicated to combating the data gaps and inequity resulting from many ethnic, racial, and other demographic groups being underrepresented in clinical research, Greater Gift has donated more than 120,000 vaccines—and meals—to children in need since 2010.

The founder of Greater Gift, Jennifer Byrne, is the CEO of Javara Research. For over 20 years, she has seen thousands of patient volunteers participate in more than 7,500 clinical trials. Whether their motivation was to find treatments for themselves or to help others by contributing to research, the positive impact these volunteers had on future generations cannot be overstated. As a way to honor these patients and their contributions, Jennifer created Greater Gift. In addition to the outreach work that brings vital awareness of clinical research to underrepresented communities, Greater Gift partners with the life science community to provide a vaccine or meal to a child on behalf of each and every clinical trial participant. 

Devana is proud to be both a sponsor and partner of Greater Gift and to help support its mission to advance global health now and for the future. Every year at this time, Devana donates vaccines in the names of each of our clients through Greater Gift. These vaccines go to children in need who are under/uninsured and who might not otherwise have access to life-saving preventative inoculations. 

We hope you will join us in donating to this worthy cause during this holiday season and beyond.

Curious about streamlining your clinical trial data?

Book a demo with Devana Solutions today to learn more about our cloud-based data analytics software for the clinical trials industry that integrates seamlessly with CTMS and other key systems to keep success in the crosshairs.

 

Partner Spotlight: Aventiv Research

Aventiv Research Partner Spotlight

Chapel Hill, NC (December 8, 2021) – Devana Solutions is happy to announce a new client-partnership with Aventiv Research, a leading independent, multi-therapeutic clinical research center with seven locations across the greater Columbus, Ohio and Phoenix, Arizona regions. As an alliance partner of hyperCORE International, a super network of highly experienced and awarded clinical research companies, Aventiv’s mission is to enrich the lives of their team members and patients by putting medical research to work. 

Founded in 2007 by Dr. Samir Arora, Aventiv Research has conducted over 475 clinical trials with more than 55 pharmaceutical sponsors and has assisted in the FDA approval of 23 medications available for use today. In addition to their research work and with over 30 years combined experience, Aventiv offers consulting services covering business development, site auditing and operations management, providing proper guidance on SOP implementation, quality assurance, staffing and infrastructure to ensure efficient and streamlined processes.

As a proven leader in the clinical trials industry, Aventiv has chosen to partner with Devana Solutions, the industry’s leading cloud-based technology provider, to help save time through workflow automation, from initial study lead through completion. “In addition to time saved, we now have robust, real-time clinical trial performance metrics to help improve trial execution and better align with our sponsors’ needs,” offered Dr. Samir Arora, President and Medical Director of Aventiv Research. “Devana’s data offerings support our goal to increase clinical trial efficiency.” Devana technology will reduce clinical trial cycle time, costs and ultimately, speed therapies to the market faster.

“I am pleased to have known Samir Arora for several years with Dr. Arora being a longtime leader in the clinical trials industry,” said Devana Solutions CEO, Barry Lake. “It’s humbling that so many of the industry leaders trust our Devana platform for metrics capture and analytics and connecting central teams to decentralized sites, and we’re very honored Dr. Arora and Aventiv Research have also placed their trust in Devana Solutions and our innovative platform.”

With an already excellent reputation for clean and quality data, it comes as no surprise that the Aventiv Research team has chosen to partner with Devana Solutions. “Our access to even more data sets will allow us to help advance our goal of expanding our expertise across vaccine, internal medicine, dermatology, and many other therapeutic areas,” added Rachel Flora, Business Development Manager for Aventiv. “As we gear up for 2022, the partnership with Devana has created a landscape for success for Aventiv. We will continue to work as a collaborative group by sharing insight and achievements to further set our network apart from our competitors.” The Devana team is excited to support this well-respected research organization to advance the clinical trials industry forward.

ABOUT AVENTIV RESEARCH:

Aventiv Research exists to make novel medicines accessible to its patients and deliver industry-best pharmaceutical data to its sponsors. Its mission is to enrich the lives of both its team members and patients by putting medical research to work. Currently operating in two states with seven independent research sites, Aventiv specializes in phase I-IV pharmaceutical, device, and diagnostic clinical trials in various therapeutic areas. Built on the core values of dedication, integrity, resourcefulness, and professionalism, the company embraces a visionary, entrepreneurial spirit that compels its ambassadors to blaze new trails with proprietary systems and processes.

Find out more at www.aventivresearch.com, Facebook, and Instagram.

 

ABOUT DEVANA SOLUTIONS LLC:

Devana Solutions®, LLC is a cloud SaaS provider driven by a core belief that data transparency through technology is critical to the selection of the top-performing research sites to align with pharmaceutical Sponsors and CROs to reduce drug development costs and cure disease.

Devana Solutions® flagship platform, IGNITE, allows integrated site networks and research organizations to standardize workflows, particularly in study startup, across site functions while allowing for the capture and display of performance metrics for dashboarding and analytics beyond site CTMS.  PROPEL extends performance data transparency across Academic Research Institutions or an expanded network of owned and affiliated investigative sites.  IQ allows for the sharing of performance data and documents in real-time between investigative sites and Sponsor or CRO stakeholders. To learn more visit www.devanasolutions.com.

 

 

 

Countermeasures Acceleration Group — the New Standard for Clinical Trials

Clinical Trials and Operation Warp Speed

248 days. From the time scientists first sequenced the genome of the COVID-19 virus and published it online, it took just 248 days for the clinical trials industry—working closely with government agencies under “Operation Warp Speed,” now known as Countermeasures Acceleration Group (CAG) —to develop two emergency-use vaccines to stem the tide of the pandemic. Other vaccines would be developed soon afterward.

 

With 5.2 million deaths and counting attributed to the COVID-19 pandemic worldwide, the loss of life alone has been staggering. Sadly, the Omicron variant will add to this devastating toll. Despite our desperation to put this pandemic behind us and return to “normal,” the clinical trials industry and its regulatory agency partners have a golden opportunity to implement some of the best aspects of CAG as the new industry standard. In so doing, the delivery of new therapies in record speed to patients desperately in need—those with diseases such as Alzheimer’s, Parkinson’s, Cancers—would stand as an enduring tribute to the lives lost to COVID-19.      

 

Formed May 15, 2020, CAG was a partnership between the federal departments of Health and Human Services (HHS), Department of Defense (DOD), and select private sector drug development sponsors. At its outset, the daunting goal of CAG was to accelerate vaccine development through 2020 so that, starting in January 2021, 300 million COVID-19 vaccine doses could be approved by the FDA, manufactured, distributed, and available to the U.S. general public by mid-2021.

 

At the inception of CAG, vaccine clinical trials were already underway with Pfizer, Moderna, Novavax, Sanofi/GSK, Janssen (J&J) and AstraZeneca. However, these trials were in the early stages, with no guarantees regarding timeline or successful outcome. And here was this lofty goal of full vaccine deployment in less than a year. For the nearly 75% of the U.S. adult population who have now been inoculated against COVID-19 and are currently contemplating booster shots, it may be easy to forget the audacity of such a compressed drug development timeline. But for those with experience in the clinical trials industry, this ambitious goal may have seemed flat out impossible!

 

If you look at the pre-pandemic statistics, the clinical trials industry has operated against a backdrop of 153,000 global deaths per day, 7,000 compounds in the drug development pipeline, and almost 12 years in clinical trials before new therapies reach patients—at an average cost of $2.6 billion! Defying the seeming inevitability of decades-long cycle times, CAG proved that an accelerated timeline was possible with an unprecedented level of process and performance transparency as well as cooperation between drug developers in the clinical trials industry and government. But what factors enabled this never-before-seen public/private cooperation to achieve the impossible, and how could those factors be standardized for future clinical trials in order to compress development cycle time and achieve faster breakthroughs in our most serious diseases?   

 

Allow each partner/stakeholder to play to its strengths  

In large part, CAG succeeded because at the outset, there was an understanding and acceptance as to which roles and responsibilities were best suited to private enterprise vs. government. For example, the heads of large government agencies such as HHS, DOD, and the State Department accepted that highly motivated, private drug development enterprises were best left to their own devices to do what they do best: execute on clinical process development and manufacturing plans—assuming successful vaccine creation.

 

For their part, the government agencies working within the CAG partnership deemed that their critical role was to mobilize the full capacity of the U.S. government to clear all roadblocks. Their job was to ensure that no technical, logistical, or financial hurdle would hinder vaccine development or deployment. For example, DOD and HHS collaborated to mitigate supply-chain disruptions of critical manufacturing supplies and equipment. HHS even worked closely with one vaccine company to identify a much-needed additional manufacturing partner. The U.S. Army Corps of Engineers was tasked with overseeing construction projects to expand capacity at some manufacturing plants. Incredibly, DOD even sent 16 public servants to fill quality control positions at two vaccine manufacturing sites until the companies could hire the required private sector replacements!

 

Certainly, promising early-stage clinical trial data should meet an agreed-upon threshold to merit such an all-out mobilization. But shouldn’t we lay down the policy guidelines now if only so drug developers and the public know that enormous public/private support will be there when a breakthrough inevitably comes? There are countless people with devastating diseases such as Alzheimer’s—which many experts caution is a developing tsunami given our aging population and longer life expectancies—waiting for just such a crucial breakthrough in treatment. 

Leverage technology-enabled solutions and data sharing to align stakeholders

Extraordinary cooperation by otherwise fierce competitors in the pharmaceutical industry became standard in the CAG effort to develop the COVID-19 vaccines. BioNTech collaborated with Pfizer for its mRNA-based vaccine. Sanofi worked in tandem with GlaxoSmithKline (GSK) and Merck manufactured J&J’s vaccine. Beneath these high-profile partnerships was one significant factor that helped CAG succeed: data-sharing. Specifically, the competitors developing vaccines on one of the four approved platforms selected by CAG—the mRNA platform, the replication-defective live-vector platform, the recombinant-subunit-adjuvanted protein platform, or the attenuated replicating live-vector platform—actually relied on data from other vaccines using the same platforms. For as much criticism as the pharmaceutical industry too often receives, this level of sharing and cooperation between fierce rivals to help swiftly combat a deadly virus preying on many of the world’s most vulnerable has, in my humble opinion, not been heralded enough.  

 

As the CEO and Co-Founder of an innovative cloud-based software provider to the clinical trials industry, I have long advocated for more process and performance transparency (as those who know me in the industry can attest). That said, let me be clear: as an entrepreneur and fierce defender of risk taking and free market capitalism, I am not in any way advocating for pharmaceutical industry sponsors and their CRO partners to share the valuable intellectual property behind new therapies they took great risk to develop and advance through clinical trials. Beyond a passion for improving the human condition and eradicating disease, respect for the rule of law and protecting intellectual property are paramount to ensuring therapeutic breakthroughs like we’ve just experienced with the COVID-19 vaccines.

 

However, in the same collaborative spirit of Operation Warp Speed, there are opportunities to use technology to better align—both operationally and clinically—all clinical trial stakeholders, from patients to investigative sites to CROs and sponsors. On the clinical side, for example, technology that uses artificial intelligence to scour EMR data and match eligible patients to clinical trial protocols is beginning to proliferate. In addition, even during the development of clinical trial protocols, predictive analytics are being leveraged to model trial feasibility based on the protocol, thereby allowing for protocol adjustments to ensure a greater degree of success in the clinical trial phase. Operationally, the pandemic has hastened promising technological advances to cut cycle time and, ultimately, costs to deliver new therapies to patients. Remote and risk-based monitoring of clinical trials is poised to become (or already is) the new norm. And of course, at Devana Solutions we provide technology to connect central trial operations teams with decentralized site staff and clinicians or “bring the site into the patient’s own community”. Devana also highly automates clinical trial process workflows and capture site metrics for analysis and improvement in speeding new therapies to patients.

—–

It is within our power to take from the urgent, can-do, cooperative partner-mindset that was adopted by the clinical trials industry and government agencies during the pandemic—best exemplified by Operation Warp Speed. The industry and regulators should seize the lessons of this moment, and lay down a framework to accelerate the speed of delivery as soon as the next major therapeutic breakthrough against a serious disease is realized. To miss the next opportunity to speed a lifesaving vaccine or cure to those patients by leveraging the collective fighting spirit this pandemic has engendered would be tragic. Rising to meet this challenge would honor the millions of lives cut short by this pandemic.

 

Book a demo with Devana Solutions today to learn more about our cloud-based data analytics software for the clinical trials industry that integrates seamlessly with CTMS and other key systems to keep success in the crosshairs.

 

2022 SCRS Global Oncology Site Solutions Summit: What to Expect

SCRS Oncology Site Solutions Summit

If you work in oncology research, you likely have your eyes set on the upcoming 2022 SCRS Global Oncology Site Solutions Summit. The team at Devana Solutions, is excited for this year’s event. Devana Solutions helps central research operations professionals and decentralized clinicians stay connected and aligned to optimize the entire clinical trial process.  The 2022 Oncology Site Solutions Summit takes place on January 28 and 29 in Austin, Texas.  If you aren’t familiar with an SCRS Site Solutions Summit event, check out our recap from the 2021 SCRS Global Site Solutions Summit.  

The SCRS Oncology Site Solutions Summit takes place at the Hilton Austin, and  offers a chance to those in the oncology research field to connect and innovate.  Here’s a preview of what to expect.  

Network with Industry Leaders

One of the advantages of attending the SCRS Global Oncology Site Solutions Summit is to connect, in person, with oncology research teams and leaders, from the sites to CROs and Sponsors to industry vendors; sharing valuable insights in an effort to advance the mission in finding new treatments and, someday, a cure for cancer. 

Between networking breaks and partner lunches, there are opportunities to connect with longstanding peers or make new professional relationships.

Learn About Innovation in the Field

The interactive discussions truly make the SCRS Global Oncology Site Solutions Summit a must-attend event.  

We are big fans of the breakout sessions. Some of our biggest areas of interest are around making the , improving clinical trial management during study startup and connecting central operations teams with clinicians.  We’ve broken down some of the sessions we are most excited about at the Oncology summit in Austin:

 

Friday, January 28, 2022

11:00 am – 12:00 pm

BREAKOUT SESSION I

Among the topics we are interested in:

  • Protocol Feasibility: Tactics & Tools for Success
  • Hybrid Decentralized Trials: Critical Considerations 
  • Trust-Building: Utilizing Your Data to Validate Your Site

 

1:00 pm – 2:00 pm

BREAKOUT SESSION II

Among the topics we are interested in:

  • Quality Focus: Does Your QMS Need a Refresh?
  • Site Perspective: Managing the Life Cycle of Clinical Trials

 

2:30 pm – 3:30 pm

BREAKOUT SESSION III

Among the topics we are interested in:

  • JIT Applications & Other Assessments: Are They Right for My Site?
  • Understanding & Integrating Electronic Clinical Trial Documentation Systems
  • Site Network Consolidation: What Does it Mean for You?
  • The Impact of Wearables in Oncology Studies

 

Saturday, January 29, 2022

10:30 am – 11:30 am

BREAKOUT SESSION IV

Among the topics we are interested in:

 

  • Site-Centricity & Relationships: The Importance of Site Needs (Option A)
  • Site-Centricity & Relationships: The Importance of Site Needs (Option B)
  • The Best Staffing Models for Better Quality, Enrollment & Margins

 

Grow Your Business at 2022 SCRS Oncology Site Solutions Summit

Through all of the networking and interactive sessions, the most important take-away from attending events like the 2022 SCRS Global Oncology Site Solutions Summit is developing new partnerships that help to carry out our mission to improve clinical trials and speed therapies to patients faster.

Are you planning on attending the 2022 SCRS Oncology Site Solutions Summit?  We’d love to chat. Devana CEO and Co-founder Barry Lake and Director of Strategic Partnerships Emily Hardy are excited to discuss how technology can improve the clinical trials space for oncology and beyond.  Connect with Barry or Emily on LinkedIn or use the contact form at the bottom of the page to set something up before the big event in Austin!

 

 

 

Why Automated Data Analytics are Crucial for Clinical Research Leaders

The sheer volume of data produced by the clinical trial industry is staggering—and it’s growing every day. The healthcare industry, in general, relies on big data to function, and clinical trials are no exception. We need speedy, secure access to data sets that are large, complex, and diverse. By and large, big data has moved onto the cloud in recent years. Yet because of the limitations of the applications and processes used by most clinical research organizations, much of the information remains siloed in different systems. We end up spending hours trying to wrangle data from multiple sources in an effort to get the insights we need to effectively manage operations. But what if the clinical data you need wasn’t just scattered across multiple software systems (and spreadsheets)? What if you had a single platform from which to manage all of the information you need to maximize the efficiency of your research and speed medications and treatments to the market? What if, instead of sifting through disparate systems to gather and analyze pertinent data, you could automatically generate your data analytics with a few clicks? Below are just a few of the opportunities made available through automated data analytics. 

Optimize Clinical Trials

With the ability to analyze trial performance data in real-time, you’ll easily choose the best sites and investigators for your research, track trial progress, make informed decisions, and improve outcomes. With more accurate data, you can improve trial efficiency and lower overall costs.

 

Ensure Accuracy & Improve Data Quality

A streamlined platform that can integrate your systems will improve the accuracy and quality of your data. Manual methods of data gathering are tedious and prone to error. With automated data analytics, it’s much easier to see inconsistencies and gain valuable insights, and you’ll save valuable time.

 

Speed Up Treatment & Drug Development

With access to more historical data and the ability to analyze it automatically, you’ll gain better insight into the potential outcomes of current and future trials. A more efficient trial process also accelerates the pace at which you can develop new medicines and treatments—and get them to the patients who need them. 

These are just a few of the benefits automated data analytics can bring to clinical research leaders. With a cloud-based SaaS that integrates seamlessly with CTMS and other key systems to provide you with automated data analytics in real-time, you’ll get instant access to the insights you need to make better decisions and increase your chances of a successful outcome.

Book a demo with Devana Solutions today to learn more about our cloud-based data analytics software for the clinical trials industry that integrates seamlessly with CTMS and other key systems to keep success in the crosshairs.

 

Transform Your Clinical Trial Processes in 2022

While those of us who work in the clinical trial space have always known that the importance of our work cannot be overstated, there’s no question that the COVID-19 pandemic has driven home the importance of the clinical trials industry to the rest of the world as well. As we reflect back on the events of the past year, Devana Solutions is proud of the role we have played in supporting the development of life-saving vaccines, treatments, medical devices, and medications that have had a positive impact on quality of life for the patients who received them. As we look forward to 2022, we remain dedicated to supporting new discoveries in the field of medical research.

At Devana, we know that clinical trials are an essential part of ensuring that real people get the care they need to live better lives. We’re also aware how limited the options have been for managing clinical trial processes. Labor-intensive manual data entry and scattered spreadsheets with incomplete or missing information are common. Often “the left hand” will have no idea what “the right hand” is doing, especially if both of those “hands” belong to a research organization conducting more than a handful of trials at once. That’s why we developed our technology—to help you bring your goals for the future of medicine into alignment with your capabilities as a site, CRO, or sponsor. 

While there’s no telling what kinds of challenges 2022 might bring; the cumbersome, error-prone processes you currently struggle with don’t have to be among them. Imagine, instead, the opportunities that will unfold with Devana’s clinical trial technology that provides you with a single, cloud-based platform with real-time data.

From pre-award through  trial completion, our platform lets you effortlessly manage all of the information along the way. Clinical trial processes become a snap when you have instant access to all the necessary data required. You won’t have to worry about inaccuracies slowing down the trial award process and startup stage, because all of the necessary data for a site can quickly and easily be assessed and shared with CROs and sponsors. 

As your single solution to standardize, streamline, and automate all of your clinical trial processes, our platform will help you align with the right trials and speed therapies and treatments to the patients who need them most. Let 2022 be the year you take the first step towards transforming your clinical trial processes with Devana Solutions.

Book a demo with Devana Solutions today to learn more about our cloud-based data analytics software for the clinical trials industry that integrates seamlessly with CTMS and other key systems to keep success in the crosshairs.

 

How Technology Simplifies Clinical Trial Feasibility Assessments

Ah, the dreaded site assessment and feasibility: pages upon pages of requests for information. From equipment specifications to investigator experience to patient population, the amount of data needed to execute a clinical trial feasibility is onerous. You may have most of this information on hand—across a variety of spreadsheets, emails, documents—and in your head. But there may also be gaps in the information you have access to, leaving you no option but to put down your best guess and muddle through.

However, the accuracy of the data you provide in an assessment is vital. Sponsors and CROs need the information in a feasibility to be as precise as possible, or else how can they be sure a site will be able to perform as needed in a trial? Miscalculations and incomplete information could prevent you from being awarded the trials you deserve. On the other hand, an inaccurate feasibility could lead to being awarded a trial that your site cannot perform well, resulting in damage to your business and your reputation. This inevitably slows down or even halts the investigational process, causing delays in much-needed therapies, vaccines, and devices making it to the market—and to the patients who would benefit from them.  

Clinical Trial Feasibility Accuracy and Innovation

In the clinical trials industry, innovation and state-of-the-art technology are a part of the job. But until now, so many sites have been relying on outdated, error-prone manual processes to store and deliver their vital information. Devana Solutions is here to change that by bringing site feasibility assessments into the 21st century. With our clinical trial process management platform, you’ll have access to all of the data you need to flawlessly execute clinical trial feasibility assessments—within seconds. 

Performance for Indications & Therapeutic Areas

Devana’s platform gives you the ability to review a site’s past and current performance, as well as their experience in particular indications or therapeutic areas. This information can be displayed for your particular site, for a specific investigator, or even for the organization as a whole. You can easily see the number of trials and average enrollment metrics for those trials, such as patient volume, screen failure rate, early term rate, and contract fulfillment percentage. 

Performance with CROs & Sponsors

Common feasibility questions about your performance with specific CROs and sponsors include queries like how many studies are you currently running or have completed for a specific CRO or sponsor? What is your average study start-up time with that same CRO or sponsor? How long on average does it take your site(s) to screen the first patient once the study has been given the “green light?” Devana’s platform instantly provides this information for you. Among other metrics, you can see the number of trials performed for each CRO and sponsor, their turnaround time, and pertinent enrollment data. 

Clinical Trial Feasibility Investigator Information

Our platform’s investigator profiles centrally house all of the crucial documentation for your investigators, including CVs, medical licensing, and training certificates. No more digging into emails, computer folders, or physical files of photocopies just to fill out the investigator information in a feasibility assessment. With Devana’s platform, everything you need is in one place.

Site Information

All of the relevant information needed for a site feasibility assessment—from the basics such as contact info to the nitty-gritty details like therapeutic area experience, equipment on-site, staff-on site, and past FDA audit outcomes—is stored in our platform’s site profiles. You won’t need to sift through countless documents and spreadsheets just to get the necessary data—our platform provides it at the touch of a button.

Financial Information

Budget considerations are a common element of feasibility assessments, requiring you to provide fiscal details in a variety of areas. This financial information includes costs related to specific indications as well as particular CROs and sponsors. Devana’s platform stores and crunches the numbers for you, so it’s available anytime you need it. 

Feasibility assessments are essential for winning trial awards, but there’s no reason they should still be a stressful, manual, error-prone process. With Devana’s platform, you’ll effortlessly give CROs and sponsors the data and the insights they need to understand your strengths and weaknesses, optimize your performance, and win study awards.

Book a demo with Devana Solutions today to bring your clinical trial feasibility assessments into the 21st century.

 

How to Better Manage Your Clinical Trial Operations

One of the biggest challenges that clinical research organizations face is managing their vast influx of clinical trial opportunities from Sponsors, CROs and other potential sources. As anyone in this industry knows, there’s a lot of effort that goes into starting up a clinical trial; from sourcing the trial, to feasibility and site selection, to contract and budget negotiations, to regulatory and the many steps in between. Even today, in this advanced digital age, most research organizations are still relying upon mundane spreadsheets and manual processes to manage their trial activities. Why are we still doing this when there is technology available to make our lives easier? Devana Solutions’ innovative platforms help to increase efficiency around clinical trial processes for research organizations of all sizes, with varying needs. 

Managing New Clinical Trial Opportunities

Devana Solutions helps you track the pipeline of new clinical trial opportunities.  

Let’s say you’re a research organization with ten site locations that was just approached with a new clinical trial opportunity. In Devana, you can create the trial opportunity, once, completing details such as the name, trial origin, therapeutic area, protocol number, etc.; details that will not change regardless of which sites are conducting the trial.

Once you’ve created the trial within Devana, you can then add all ten sites to the trial, which creates a site activity and enrollment record for each site. Whether startup activities are handled centrally or at the site level, you will be able to track the completion of necessary milestones within Devana. If certain milestones are handled centrally, you only have to update the milestone once from the main trial page instead of having to update each individual site record, 10 different times.

Devana also offers built in, automated task management so important tasks never get missed, since we know there are many moving parts in managing a trial, in all stages.

Simplify Feasibility Questionnaires

One of the more frustrating situations during the feasibility process is not having complete data to quickly and easily respond to feasibility questionnaires.

When you have this information in a comprehensive system like Devana Solutions, it makes responding to a feasibility much easier since everything is at your fingertips.

One area where this is immensely beneficial is having concrete data surrounding your investigators’ historical and current trial performance. When completing feasibilities, do you know, without hesitation, how many trials they’ve participated in? Can you easily tell how many they are actively conducting? Or perhaps the feasibility is asking for data related to the indication. Do you know how many trials you’ve completed in a particular indication? What about your average enrollment percentage in that indication? Or screen failure and patient retention percentages? Devana Solutions allows you to instantly access data whether it’s sorted by the trial, indication, investigator, site or the entire organization.

Sort Your Decentralized Site Data in Seconds

In the age of decentralized trials, it can be difficult to sort through each sites’ capabilities to determine which sites are compatible when presented with a new trial opportunity. Sure, you may have a spreadsheet detailing each sites’ therapeutic capabilities and equipment on site, but how time consuming is it to sort through this information manually? Or what if a site makes a sudden change to their capabilities? How can you be confident that the information you have on hand is accurate? Certainly, you can call or email the site each time you receive a new feasibility, but who has time for that? 

These manual processes may not be too cumbersome if you have two or three sites, but what happens when you have two to three dozen or more?  Devana Solutions tracks all of the key information for each site so that you are able to quickly query the data for all site locations to determine which sites or investigators are capable of conducting a particular trial. But how can Devana help ensure that you always have the most accurate data on your sites? Through Devana’s site-facing interface, LYNK, which allows site-level users to update their capabilities in real-time, so that your teams can be rest assured that the information they rely upon for precise site-selection is accurate.

Is your site maximizing its potential to conduct trials more efficiently and reliably? Are you easily able to access critical data to make better business decisions? If not, you’re not alone. Come join the numerous industry leaders who made the decision to partner with Devana.  Book a demo with our team by clicking here, or fill out the form at the bottom of this page.  

 

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