Like coffee and great conversation, some things just go great together. This week, two clinical trials industry tech players are set to reframe the narrative around how technology can unlock the power of your clinical trial site, site network or academic research center’s data and turn it into actionable information allowing you to run a more efficient site and use analytics and reporting to win more of the right award letters. We’re pleased to announce the integration between Devana Solutions, LLC’s innovative Devana IGNITE platform and Clinical Research IO (CRIO). Together, their complementary systems will help boost efficiency at the clinical trials site level, decreasing clinical trial cycle time to speed therapeutic advances to patients.

Devana Solutions IGNITE for sites is an easy-to-use software platform that simplifies the complex pipeline management process by consolidating all trial opportunities in one place. IGNITE makes the management of business development, feasibility, contact and account management, study start-up activities and all-around study execution and performance metrics capture and analysis easier and faster. Combining Devana IGNITE and CRIO’s leading CTMS technology essentially provides site networks, integrated research organizations and academic research centers with an “operating system” from study start-up all the way through trial completion.

CTMS programs – or “Clinical Trial Management Systems” – such as CRIO’s leading technology, have become “must have” technology over the last two decades in helping research sites to automate clinical trial workflows once patient screening and enrollment commences or, when the “clinical” part of a trial begins as the product name would imply. However, until Devana Solutions launched its transformative Devana IGNITE platform, there were no robust solutions short of static spreadsheets and countless email folders to gather critical study information, organize site workflows and capture key timing metrics during the study startup phase. Similarly, while the clinical staff of research coordinators, patient recruiters and site operations and accounting personnel depend daily on a leading CTMS solution like CRIO to help automate their clinical and billing functions, the Leadership Team at most leading site organizations benefit more from transparency into clinical trial performance metrics for analysis and decision-making, “business intelligence” capabilities where Devana IGNITE also excels. Therefore, with Devana IGNITE’s robust study startup features and performance metrics capture for reporting and analysis coupled with CRIO’s innovative CTMS technology for the clinical phase, site networks, integrated research organizations and institutional sites can leverage an end-to-end solution.

Information is critical to informed decision-making, monitoring progress and evaluating outcomes. In no industry is this more critical than clinical trials where the focus on creating efficiencies such as Devana Solutions seamlessly integrated with CRIO CTMS will drive the delivery of new therapies to patients faster and less expensively.

Learn more about powering your site’s success in the CRIO podcast “The 5 Metrics Every Site Should Track,” featuring Devana’s CFO, Sean Rice. Discover more here.

Devana Solutions, LLC is always proud to partner with the brightest, most innovative minds in the clinical trials industry. This week we’re pleased to announce the addition of Charter Research to the game-changing Devana IGNITE platform. Charter Research is led by industry experts Jeff Pohlig, MBA and Jessica Sletten, MBA, two of the nation’s most highly regarded clinical trials executives. The Charter Research team is passionate about developing new therapies and breakthrough drugs so that people around the world can live better, healthier lives. We’re proud to continue our mission, supporting the backbone operations of work that envisions a better future for generations to come. #clinicaltrials #metrics #clinicalresearch #innovativetechnology

 

 

Devana Solutions, LLC is committed to partnering with some of the world’s leading research sites to help shape the future of the clinical research industry. This week, Devana is pleased to announce the addition of Meridien Research and it’s affiliates to our growing subscriber-partner base. They’ve adopted Devana IGNITE for sites, a user-friendly software platform that simplifies the complex pipeline management process. IGNITE makes the management of business development, contact management, startup activities, study execution and performance metrics capture and analysis easier and faster.

By partnering with CROs and sponsors, Meridien Research study sites continue to be among the leaders in medical research and clinical trials in Florida. Meridien Research provides patients and families an opportunity to take part in clinical research trials for a wide variety of medical conditions. The professional teams at Meridien Research are experienced primarily in Phase Ib – Phase IV trials across a wide variety of therapeutic areas, including psychiatry, neurology, internal medicine, gastroenterology, OB/GYN, urology, cardiovascular risk-factors, endocrinology, and dermatology. Their studies across multiple locations in Central Florida, and its latest acquisition in Decatur, Georgia called NeuroStudies, help to further science and medicine.

It’s with great pride that we partner with another leading research site whose studies aid in the development of medical therapies that may offer better treatments, and even cures, for life-threatening and chronic diseases. We’re thrilled to welcome them aboard to help them drive better data, better decisions and better outcomes.

https://www.linkedin.com/company/devana-solutions-llc

The following except is taken from Scaling and Innovating: the Consolidation and Reinvention of Clinical Research Sites, an eBook courtesy of Clinical Research IO.

Please click HERE to view the entire eBook.

Barry Lake is the CEO and co-founder of Devana Solutions, a business analytics, startup and metrics capture solution for research sites and site networks. Prior to starting Devana, Barry ran a research site, where he personally experienced the frustrations of managing a complex pipeline of studies. Barry is a serial entrepreneur who has started and sold various companies in different industries but is presently focused on the clinical trials industry.

 

TELL US ABOUT HOW YOU STARTED DEVANA.

The genesis was when I was running a site along with my main business partner and one of our key managers. We observed a lot of inefficiency in the study startup process. We didn’t have a good way to track milestones from initially hearing about a lead all the way through award date, SIV date, first patient in and so on. At the same time, we began hearing from larger CROs that they
were keeping metrics on our site including metrics on how fast we performed in start-up and, of course, screening and enrollment performance. We knew our site was a top performer in our core indications; but we learned that one of the largest CROs had our site on a blacklist, so we tracked them down. The person who maintained the database told us that we were a “zero enroller” on 6 studies. However, their conclusion was based on the fact we were awarded 6 studies; but, in reality, for various reasons, we never actually contracted for those studies. For example, in a couple cases we had competing studies so knew we might struggle enrolling on two very similar trials and, on a couple more, the budget being offered was not sufficient. For all six studies there were valid reasons we passed; but, that CRO’s bad data was standing in the way of our site being considered for future trials.

Based on this painful experience, we quickly realized we needed to take control of our own site performance metrics. That’s when we conceived of the idea behind the Devana Solutions technology. Our software enables sites to keep track of their study pipeline, track critical metrics such as turnaround time on feasibility, contracts, budgets and run reports across start-up milestones and enrollment performance. By the way, one thing we learned is that many of these CRO’s, despite even their own size and sophistication, aren’t using very robust systems themselves. Many times, it’s their spreadsheet vs. the site’s.

“Many times, it’s the CROs spreadsheet vs. the site’s.”

 

SO YOU KNOW A LOT ABOUT BUSINESS DEVELOPMENT. WHAT IS THE KEY TO BUSINESS DEVELOPMENT?

Obviously, you have to be a good site. Let’s assume that for the sake of discussion.

For business development purposes, you need to develop strong relationships. Clinical Trials BD like all sales is very much a people game. A good business development professional is someone who can work independently, is self-motivated and can build and nurture relationships.

But, since it is heavily regulated, the clinical trials industry is very paperwork intensive and study start-up can take a long time. From the time a site gets the first lead about a study to the time it receives an award letter and is greenlighted to begin enrolling, people at the site will, on average, interact with 7 to 8 different people from the sponsor or CRO. Part of this is because of specialized roles at each step of the process, and part of this is probably just natural position changes or turnover. So, a good BD person needs to navigate these relationships and transition effectively, and to do that he or she needs tools to efficiently manage workflows and continuously assess how the site is performing.

For that, you need some kind of a system to track and capture your site’s own performance metrics. Why cede control of your destiny to someone else that says they’re tracking your performance? You should have, at your fingertips, information on your pipeline, your past performance and the specific milestones and metrics of every study you’re working on or have completed in the past and Devana technology does exactly that. “Why cede control of your destiny to someone else who says they’re tracking your performance?”

 

HOW MUCH DOES A BUSINESS DEVELOPMENT PROFESSIONAL COST? WHAT DO YOU DO IF YOU’RE A SMALL SITE?

My guess is they can range from $80,000 to $150,000 dollars a year depending on the market. Add conferences and travel, and you could be easily looking at a $200,000 annual investment. So, a dedicated BD role is something that usually requires a site generating $2 million of annual revenue or more.

For smaller sites, joining a network may make a lot of sense. That way, you’re combining efforts and using that scale to invest in a business development function.

“Why cede control of your destiny to someone else who says they’re tracking your performance?”

 

WE HEAR A LOT ABOUT SITE METRICS. WHO IS COLLECTING THEM, AND WHAT KINDS?

A lot of people are collecting these metrics. The large CRO’s and Sponsors are doing this. Software vendors are. Industry consortiums such as Transcelerate are likely taking steps in this direction.

At the site network I was a part of years ago, each month we’d meet with the top CRO’s and review site study performance and the CRO’s current pipelines. They were always tracking how our sites were performing in the start-up and enrollment process – how many patients each site screened, randomized, etc. Most of the CRO’s were using their own systems to capture these metrics.

I want to stress again how important it is that sites track their own metrics. Because there are other study stakeholders trying to track progress, it’s incumbent upon sites to be engaged in the dialogue and know their metrics cold.

 

WHAT DO YOU THINK OF THE RISE OF SITE NETWORKS? DO YOU EXPECT THIS TO CONTINUE?

Consolidation is here to stay, and here’s why. The CRO consolidation is more or less done – the top 6 or 7 CRO’s have emerged, and they control 70% of outsourced spending from sponsors. Many of the same financial investors that rolled up the CRO space are now rolling up the site space. I date the start of this trend to 2015, when PPD, through a related company, effectively acquired
Radiant Research’s sites and the next year, Synexus. But this trend still has a long way to go.

Most of these integrated site networks are looking for sites with $1 million in cash flow. Personally, I question how many sites of that scale are out there – maybe somewhere in the low to mid-hundred’s in the U.S., based on analysis I’ve seen. Eventually, some of these networks trying to grow in scale may have to explore other avenues for growth such as greenfielding new sites or growing smaller existing sites.

 

WE HEAR THAT SPONSORS ARE STILL MAKING SITE SELECTION DECISIONS BASED ON INDIVIDUAL PI EXPERIENCE, AS OPPOSED TO THE OPERATIONAL CAPABILITIES OF THE SITE OR NETWORK. IS THAT THE CASE?

There is wisdom in stressing PI experience for rare disease trials because of access to patients. Over time, if integrated site networks achieve size and scale, I think the industry could shift from a PI-centric perspective to more of a site-centric view.

“Many of the same financial investors that rolled up the CRO space are now rolling up the site space.”

 

WHERE DO YOU THINK WE’RE HEADING AS AN INDUSTRY?

I think data transparency is where things will go and, at Devana Solutions, wewant to help lead the way. The best analogy to gauge where the clinical trials industry is headed would be to look at the history of the financial sector. Back the 50’s, there were no standards for determining who was creditworthy. Bankers would come to people’s homes, perform interviews and make subjective
decisions based on your neighborhood and even the quality of your existing furniture. You can imagine all kinds of problems arising from such a process. Then the financial industry came up with FICO scores standing for the Fair Isaac Credit Organization after the co-founders. Now, every lending decision is driven off that more objective measure, a common standard. If you think about it, we’re doing investigational research on real patients, and lives are at stake. But there is no standard or uniform measure around site performance. That’s got to change, and I believe that will change.

 

Devana Solutions®, LLC is a SaaS provider driven by a core belief that data transparency through technology is critical to selection of the top performing research sites to align with pharmacensors and CROs to reduce drug development costs and cure disease. Devana Solutions® offers three platforms, IGNITE, PROPEL and IQ for sponsors and cros, to provide historical and real-time data capture, aggregation and display to drug development stakeholders.

For questions and to schedule an introductory call or demo, contact Barry Lake, CEO & Co-Founder.utical Spo

Barrylake@devanasolutions.com

(301) 471-6962

Devana Solutions, LLC is thrilled to announce the addition of yet another industry-leading research organization onto Devana Solutions, LLC IGNITE, an innovative site operations and analytics platform. Segal Trials is a network of 6 research sites focused on women’s health, mental health and addiction. With offices in South Florida and South Carolina, Segal Trials conducts Phase I-IV research trials. Recently, Segal Trials was recognized for their creativity by being crowned the winner of the 2019 PopUpStar Competition, where sites around the world compete to help promote Clinical Research as a Care Option. Devana Solutions, LLC salutes and offers our sincere congratulations to Segal Trials on receiving this honor!

We proudly support Segal Trials mission and look forward to our innovative Devana Solutions, LLC technology supporting the network as they lead the way in leveraging data analytics to drive clinical trial cycle time reduction to ensure advanced therapies get to patients faster and more cost effectively.

https://www.linkedin.com/company/devana-solutions-llc

Devana Solutions, LLC is proud to announce their newest partner-client, Evolution Research Group (ERG). Congratulations to ERG on joining the bold roster of research organizations leveraging the innovative technology at Devana Solutions, LLC to capture and display performance metrics to prove therapeutic strengths and enrollment capabilities, and study start-up/timing metrics to constantly improve efficiency and prove their operational-expertise to Sponsors and CROs. Evolution Research Group is one of the largest research organizations in the nation with 13 sites focusing on conducting clinical trials for healthy individuals and those suffering from pain, neurologic and psychiatric disorders, special populations, NASH, diabetes and other debilitating diseases. Their research subjects make medical discoveries and scientific developments possible. Using the Devana Solutions, LLC platform, Evolution Research Group is certain to save time and increase productivity to accelerate therapeutic advances for less cost.

https://www.linkedin.com/company/devana-solutions-llc

 

Last week we featured the Top 5 Metrics for Winning More Studies, Part 1. In part 2 of our feature, we’ll introduce you to the Devana Solutions IGNITE platform for Sites. IGNITE is an easy-to-use software platform that simplifies the complex pipeline management process by consolidating all trial opportunities in one place.  IGNITE makes the management of business development, contact management, start-up activities, study execution and performance metrics easier and faster.

Purpose & Value Proposition.

Benefits:

1. An end to end solution to easily capture data, or manage data form other systems such as CTMS.
2. Track and report all timing and performance metrics.
3. One custom platform for transparency, efficiency and accountability.
4. Better data helps operations to:
   • Identify bottlenecks, implement improvements and performance benchmarks
   • Increase revenue by negotiating from a position of strength, trend identification and optimizing trial opportunities.
   • Demonstrate reliability, predictability and accountability to Sponsors/CROs.
   • Use data trends to allocate resources, develop new capabilities and identity areas for growth.

Trial Milestone Tracking & Reporting.

Benefits:

1. Customized milestones and workflows to manage entire start up process.
2. Real-time metrics and reports on individual and aggregate trial performance.
3. Current recruitment numbers, enrollment rate and contract percentage.
4. Trial stage automatically advances as milestones are completed.
5. Compare internal vs. Sponsor/CRO timelines for key milestones.
6. Track key budget and negotiation details.
7. Automated and custom reminders and tasks assigned to staff for key milestones.

Timing and Performance Metrics Reports.

Benefits:

1. Combined trial data for analysis and trend identification.
2. 100+ standard reports.
3. Unlimited custom reports
4. Export, print, or create a visual dashboard.
5. View data for any time-frame.

Real-Time Study Status Reports.

 

Benefits:

1. View full study pipeline, stage and compare progress across all sites.
2. Full visibility of workflows and next steps across the team- saves time and reduces risk.
3. Establish benchmarks to improve efficiency and measure improvement.

Devana Solutions®, LLC is a SaaS provider driven by a core belief that data transparency through technology is critical to selection of the top performing research sites to align with pharmaceutical Sponsors and CROs to reduce drug development costs and cure disease. Devana Solutions® offers three platforms, IGNITE, PROPEL and IQ for sponsors and cros, to provide historical and real-time data capture, aggregation and display to drug development stakeholders.

For questions and to schedule an introductory call or demo, contact Barry Lake, CEO & Co-Founder.

Barrylake@devanasolutions.com

(301) 471-6962

Metrics in a Changing Site Landscape

Today’s research organizations face more challenges than ever before. Cycle time reduction, operational efficiency and standardization, revenue growth, and regulatory needs are increasing the complexity of site operations.

Many research organizations look to operational data and metrics to track, manage, and ultimately improve their performance in key areas. As Sponsors/CROs collect data on sites for their own use, it’s even more important for a site to know their own metrics.

While there are hundreds of data points and metrics that can be measured, they typically fall into the categories of timing or performance metrics.

Key timing and performance metrics are then used to find bottlenecks and establish benchmarks to improve operational efficiency, and to help win more study awards through demonstrating a site’s predictability and reliability to a Sponsor/CRO.

Here are the top five metrics used by research organizations successfully winning more awards aligned with their capabilities using the Devana Solutions operations and analytics platform.

 

#1 – Time from Award to Active

Why Track?

This metric, measured in number of days, demonstrates that your site can mobilize quickly, and reflects the level of organization and efficiency a Sponsor/CRO can expect from your site.

 

What to Measure?

The Site Activation Date – The Date of Award = The Time from Award to Active in days. Calculate the average or median across all trials.

 

Bonus Tip!

Not impressed with your site’s performance data? Use the data to reflect an improvement. Is there a positive trend (Ex. 25% reduction in the last 2 years)?

 

#2 – Days from Active to Screening

Why Track?

This metric, also measured in number of days, shows that once a site is activated, they are immediately screening patients. This is reflective of a thoroughly planned and executed Patient Recruitment Strategy.

 

What to Measure?

The Date of First Patient Screened – Site Activation Date = The Days from Active to Screening. Calculate the average or median across all trials.

 

Bonus Tip!

As trials can have unexpected delays out of a site’s control, measure days from Site Activation rather than Start Date. Once Activated, there are fewer variables that can impact a site’s timing.

 

#3 – Contract Met Percentage by Indication

Why Track?

Almost half (49%) of sites awarded a trial either under enroll or do not enroll at all.

As the saying goes: “past performance is the best predictor of future success.” This metric represents a site’s historical enrollment performance within an indication and is one of the best predictors of expected enrollment.

Showing that the contracted number of patients within an indication is met, or even exceeded, reduces the risk to the Sponsor/CRO in awarding a trial to your site.

 

What to Measure?

By Indication: Completed Number of Patients / Contracted Number of Patients x 100 = The Contract Met Percentage on the Trial. Calculate the percentage across all trials in the same indication.

 

Bonus Tips!

Track the Primary and Secondary Indications to have options in reporting, and more relevant data.

Once you’re tracking completed trials, start measuring currently running trials to see trends.

Determine your trends! How does this metric look as a 2-year average? 12 months? Across all historical trials?

 

#4 – Patients Completed, Screened and Enrolled by Primary Indication

Why Track?

Three different metrics: 1) Patients that have Completed a Study; 2) Patients who have been Screened; and 3) Patients Enrolled. Patients Completed or Screened are more likely to participate in a trial which – from the perspective of a Sponsor/CRO – means a site should not have enrollment issues and is likely to enroll faster.

Patients Enrolled shows current performance in that indication and, simultaneously, that the site is not overextended in that indication.

 

What to Measure?

Completed Number of Patients from all historical trials, by Primary Indications.

All Patients Screened for a primary indication, track by Primary Indications.

Patients Enrolled on all current trials within Primary Indications.

 

Bonus Tip!

Track Secondary Indications as well for options in reporting and more relevant data.

 

#5 – Studies in Indication by PI and Site

Why Track?

Demonstrates the experience of the PI and site within the indication which communicates experience and confidence to the Sponsor/CRO. Experience within the indication can also mean quicker enrollment or certainty of reaching or exceeding contracted enrollment.

Tracking pending, enrolling and completed trials tells a story of the ability of the PI and site to deliver results, and shows that other Sponsors/CROs have trusted the organization with their study.

 

What to Measure?

For each PI and site, track studies in the pipeline, in progress, and completed. Track the primary indication and any relevant secondary indications for each study for help with filtering future search results.

 

Bonus Tips!

Also track the Sponsor/CRO on each study to show indication experience with those specific organizations.

Track other relevant PI experience such as having been a Sub Investigator, certifications, credentials, awards and recognition, interest in other indications, and for new PI’s, track those interested in doing research.

 

Recommendations and Next Steps

Having the data and metrics through tracking all relevant associated trial details such as CRO, Sponsor, Indication, etc. provides options on how to tell your site’s story when seeking trial awards from Sponsors and CROs.

Metrics for winning awards are part of the larger pool of Site Operations Metrics. To win more awards, track and analyze your site’s key timing and performance metrics.

The best time to plant a tree is 20 years ago, the second-best time is today! If you don’t have historical data, start now! Most organizations only provide two years or less of performance metrics.

Start small with the five key metrics provided, but if you want even more awards and site efficiency now, Devana Solutions can import any historical data and have a site automatically capturing new metrics within a few weeks.

Research organizations using the Devana platform know that our technology and their metrics are proven to standardize workflows, improve communication, cut trial cycle times and win more awards.

Next week, in part 2 of this series, we’ll spotlight a few features of the Devana platform. For questions, or to learn more, explore our website, DevanaSolutions.com, or contact us today.

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About Devana Solutions, LLC

Devana Solutions®, LLC is a SaaS provider driven by a core belief that data transparency through technology is critical to selection of the top performing research sites to align with pharmaceutical Sponsors and CROs to reduce drug development costs and cure disease. Devana Solutions® offers three platforms to provide historical and real-time data capture, aggregation and display to drug development stakeholders: IGNITE for sites and PROPEL for networks,advanced operations and data analytics technology for sites and site networks and IQ for Sponsors and CROs. www.devanasolutions.com

Contact: Matt Smith, Executive Director, Strategic Partnerships msmith@devanasolutions.com (608) 285-2151