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Reflections on the Early Stages of Creative Disruption in the Clinical Trial Site Sector and the Tipping Point now finally upon us

(Chapel Hill, NC) April 11, 2018 –  Title:  Reflections on the Early Stages of Creative Disruption in the Clinical Trial Site Sector and the Tipping Point now finally upon us

By Barry Lake, CEO & Co-Founder, Devana Solutions®

Last Wednesday, April 11, 2018 we were proud to issue a joint press release with the Association of Clinical Research Professionals for the ACRP-Devana Solutions® 1st Annual Site Metrics Challenge Study.

We are very honored to work with ACRP and three of our valuable site organization partner-clients, IACT Health, LMC I Manna Research, and PMG Research, to analyze site and network timing and performance metrics data relative to clinical site staff training and development initiatives. The year-long Study in support of ACRP’s clinical trials workforce development goals will kick off at the ACRP Expo on April 27 – 30 in the D.C. area (https://devanasolutions.com/04112018-acrp-and-devana-solutions-launch-first-annual-site-metrics-challenge-study/). The upcoming Expo will mark just the second anniversary since Devana Solutions® first launched commercially at the ACRP Expo in Atlanta in April 2016 with our inaugural cloud-based Site Operations Management Software offering now called IGNITE FOR SITES. As a result, the announcement gave me pause to reflect.

What has changed since our upstart tech company embarked upon our quest to bring data transparency to the fragmented and opaque clinical trial site sector where the real work of clinical trials – seeing actual volunteer patient-subjects – truly happens?

It seems like just recently the pharmaceutical industry turned its full attention to efforts to streamline study start-up in a quest to reduce overall trial cycle time and costs. If reducing study start-up time is critical to cutting costs to advance new therapies, then doesn’t it stand to reason that the industry would rapidly gravitate towards those trial sites and site network organizations that employ Devana Solutions® advanced technology? The platform provides cross-functional teams at those early-adopting trial sites and networks with organization-wide transparency into each milestone and pain point in trial start-up so that responsible staff can rapidly mobilize to address bottlenecks and delays in order to clear the way for the important work of patient recruitment and screening? Further, shouldn’t trial sites and networks rapidly embrace such a system to allow their leadership to drive operational improvements to combat recurring start-up hurdles? What if the same advanced system also automatically captured critical site timing and performance metrics allowing those site and network leaders to easily prove their trial management expertise in their chosen therapeutic strengths?

In a drug development industry that is notoriously slow to adopt change, our young company’s efforts at creative disruption through these technological innovations targeting the clinical trial site sector have, admittedly, not inspired a tsunami of industry Sponsor, CRO or site sector demand…until now.

With gratitude to the former INC Research’s, now Syneos Health’s visionary Catalyst Program which continues to forge ahead past usual resistance, the April 11, 2018 announcement of the ACRP – Devana Solutions® 1stAnnual Metrics Challenge Study may well stand as the “tipping point” for our data transparency platform to align top-performing research sites with Sponsors and CROs to reduce drug development costs and cure disease. What gives me confidence to put forward such a claim?

With a nod to Mr. Gladwell’s 3 Rules of Epidemics; specifically, “The Law of the Few” which, in economic terms, manifests itself in the “80/20 Principle or, the idea that in any situation roughly 80% of the ‘work’ will be done by 20% of the participants”, I have recently been sending notes of thanks and taking the opportunity in my daily interactions to thank all of the “connectors”, “mavens” (information specialists) and “salespeople” whom all continue to be tireless advocates of our Devana Solutions® technology. I have been humbled to point out the following to them:

Right now, 3 of the Top 5 Largest Integrated Site Networks or Organizations in the world have embraced the Devana Solutions® IGNITE FOR SITES platform. PMG Research, IACT Health and LMC I Manna Research stand as industry-leaders in the clinical trials site sector. These 3 organizations have the confidence in their capabilities and vision to embrace our platform and leverage data analytics to further improve what are already efficient site operations. I have no doubt this will propel their site organizations even further ahead of their competitors in clinical trial management and execution.

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 two platforms, IGNITE FOR SITES, an advanced operations and data analytics technology for sites and site networks and MATCH PERFORMANCE, to provide historical and real-time data capture, aggregation and display to drug development stakeholders. To learn more visit https://devanasolutions.com.

CONTACT:

Matt Smith, Executive Director, Strategic Partnerships

msmith@devanasolutions.com

(608) 285-2151

ACRP and Devana Solutions® Launch First Annual Site Metrics Challenge Study

(Chapel Hill, NC) April 2, 2018  – In Collaboration with Industry-Leading Site Networks

Washington, DC – The Association of Clinical Research Professionals, a non-profit setting standards for clinical research competence and workforce development, and Devana Solutions today announce an initiative to analyze research site and network performance data based on workforce qualification.

The study will analyze site and network timing and performance metrics data relative to clinical site staff training and development initiatives.

The year-long study, known as the 2018-2019 Annual Site Metrics Challenge Study, will be headlined by three industry-leading integrated site networks, including: IACT Health, a 10-site network throughout Georgia; LMC|Manna Research, an 18-site network across Canada; and PMG Research, Inc., a network of 14 integrated sites based in North Carolina and operating in the Mid-Atlantic & Midwest regions.

“In support of ACRP’s workforce development goals, we believe it is critical to analyze site staffing, training, and development training initiatives and their impact on performance,” says Jim Kremidas, ACRP Executive Director. “Since Devana Solutions’ software helps sites capture key metrics for display and analysis, it is a natural fit to collaborate with them on the study.”

“Our industry is notoriously slow to change,” adds Barry Lake, CEO of Devana Solutions, “but it’s starting to realize the need for data and analytics to improve clinical trial efficiency. Now, with industry-leading site networks such as PMG Research, LMC-Manna Research, and IACT Health having embraced our technology to drive operational analysis and improvement, it was a given to have these three leading organizations headline the first Annual Site Metrics Challenge Study.”

“Making the clinical research community stronger is central to ACRP and a core value shared by all leaders in the clinical trials industry,” stated Dr. Jeff Kingsley, CEO, IACT Health, “we are pleased to headline this effort with our industry peers.”

“Training and continuing education have always been central at LMC|Manna Research,” says Karri Venn, President, Research, “and we’ve always been supportive of ACRP’s efforts in raising the standards in the professional development of those involved in clinical research. We applaud ACRP and Devana Solutions in studying performance in such a holistic way and are excited to participate.”

“PMG Research has always embraced technology innovation as an important way to develop our business and fulfil our goal of bringing clinical research to as many people as possible,” says Kathy Cole, PMG’s Associate Director of Feasibility, “so helping lead this study for ACRP and Devana Solutions is a perfect fit.”

The ACRP – Devana Solutions Annual Site Metrics Challenge Study kicks off at the ACRP 2018 annual conference, April 27-30 at National Harbor, MD, just outside Washington, DC, and continues through the ACRP 2019 annual conference. Visit Devana Solutions at ACRP 2018 in Booth 304 to learn more and sign up.

Every research site or network using Devana Solutions’ IGNITE FOR SITES operational platform is encouraged to participate. Site and network category leaders will be recognized at ACRP 2019 in Nashville, TN.

For sites interested in participating but not yet benefitting from the IGNITE FOR SITES technology, Devana Solutions will be running promotional pricing and incentives from now through ACRP 2018.

About ACRP

ACRP supports clinical research professionals through membership, training and development, and certification. Founded in 1976, ACRP is a Washington, DC-based nonprofit organization with more than 13,000 members who work in clinical research in more than 70 countries. ACRP’s vision is that clinical research is performed ethically, responsibly, and professionally everywhere in the world. ACRP’s mission is to promote excellence in clinical research. www.acrpnet.org

About Devana Solutions

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 two platforms, IGNITE FOR SITES and MATCH PERFORMANCE, to provide historical and real-time data capture, aggregation and display to drug development stakeholders. www.devanasolutions.com

Devana Solutions CONTACT:
Cindy Tremblay
+ 1.843.805.4039
ctremblay@devanasolutions.com

Consolidation Trend Pressures Independent CROs to Refocus Strategy

Barry Lake, CEO, Devana Solutions, LLC
Barry Lake, CEO, Devana Solutions, LLC

(CHARLESTON, SC) November 30th, 2017 — An ongoing industry consolidation of contract research organizations (CROs) whose services are used by large drug manufacturers is a significant trend that will only increase in the days to come, says Barry Lake, chief executive officer at Devana Solutions, LLC.

Sponsors are putting pressure on CROs to be more efficient as they also seek to broaden their trial coverage in a wider swath of therapy indications, Lake says. “Down at the site level, this consolidation should be a bit of a wake-up call,” in part because it’s been such a fragmented market for so long, he adds.

Related to this trend is the fact that site selection for clinical trials remains one of the biggest challenges for sponsors and CROs, with almost half of sites ultimately enrolling zero or one patient, according to Lake. Those under-performing sites cost sponsors more than $4 billion annually.

“The challenge of sorting good and bad sites is difficult in a fragmented cottage industry with very little publicly available data on research site capabilities,” Lake says.

In Lake’s view, sites have two basic choices when it comes to addressing the trend toward consolidation as it gains momentum: 1) redouble efficiencies and strategies to remain independent and competitive or 2) make themselves a more attractive acquisition target. Sites choosing the latter strategy can improve their visibility and cash flow if they better position themselves to meet a sponsor’s focus.

Using Data Analytics to Optimize Site Performance and Prepare for the Wave of Consolidation Impacting the Site Sector – Join Lake at ACRP 2018 to learn steps you can take today to implement processes and use data analytics to tout and display your site’s therapeutic and operational strengths while proactively shoring up weaknesses. Learn More

For sites that wish to remain their own boss, so to speak, Lake says the key is taking a hard look at operational efficiencies to assess “what you’re good at and where you’re weak.” For example, if it is taking two weeks for the site to accomplish a feasibility analysis chore for sponsors that should be done in three days, there are issues to address.

It’s not as easy it might sound, Lake admits. Sites are under such extreme day-to-day pressures, it can be difficult to take a pause and consider the long-term, bigger picture.

Author: Michael Causey

IACT HEALTH IS THE LATEST GROUP OF SITES TO ADOPT DEVANA SOLUTIONS® IGNITE FOR SITES, A TRANSFORMATIVE TECHNOLOGY PLATFORM

(CHARLESTON, SC) November 29th, 2017 — Iact Health has just become the latest network of clinical research sites to take advantage of Devana Solutions® IGNITE FOR SITES advanced central data analytics technology for clinical trial sites. The decision puts the 12-year old network of sites in good company as many of the industry leading sites and networks that have adopted Devana’s IGNITE can report not only their historical performance metrics but can also capture and deliver their site timing and performance metrics to Sponsors and CROs in real time. This will enable Iact Health and other leading trial site networks on IGNITE FOR SITES to align therapeutically and operationally with those Sponsors or CROs seeking to conduct clinical trials where Iact’s performance is second to none.

“Ultimately, this alignment between the top trial sites, Sponsors and CROs through Devana Solutions technology is at the heart of our mission,” explains Barry Lake, Devana’s CEO. “The greatest impact we can make on lowering drug development costs is through cutting clinical trial cycle times and our platform aims to do just that.”

“Prior to implementing Devana Solutions IGNITE FOR SITES system, we were struggling to effectively track our site metrics through a combination of our CTMS (Clinical Trial Management Software) and a myriad of Excel Spreadsheets,” states Felicia Irvin, Vice President of Sales and Marketing at Iact Health. “Now, the Devana technology, has everything in one centralized place and we can quickly and efficiently access our site’s performance metrics to analyze and complete a Sponsor Feasibility questionnaire in minutes.”

Iact Health is an integrated network of 10 strong investigative sites with a wealth of clinical trial experience in over 25 therapies with particular strength in Pulmonary Disease, Infectious Disease and Dermatology. Led by Dr. Jeff Kingsley, a clinical trial industry leader, and headquartered in Columbus, Georgia, Iact Health has completed well over 300 studies. Over 100 Physician Investigators have conducted studies with the Iact Health site network and the group employs 11 full-time Clinical Research Coordinators (CRC). Iact has won awards ranging from “Top 10 Best Places to Work in Georgia” according to Georgia Trend Magazine (2009), the “Psychologically Healthy Workplace Award” from the Georgia Psychological Association (2012) and more recently, the “Rockstar Award” as bestowed by the Georgia Department of Economic Development (2016).

ABOUT IACT HEALTH:

IACT Health is a wholly owned clinical research company staffed entirely by specialists. Our specialists range from patient coordinator specialists to regulatory specialists to disease specialists. Across Georgia, our staff applies the highest level of expertise to conduct studies in Pharmaceutical, Biotech and Medical Devices industries. We pride ourselves on providing the highest level of quality care for patients, and our guarantee of optimal results for CROs, Sponsors, and physicians.

ABOUT DEVANA SOLUTIONS LLC:

Devana Solutions®, LLC is a SaaS provider driven by a core belief that data transparency through technology is key in 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 two platforms, IGNITE FOR SITES and MATCH PERFORMANCE, to provide historical and real-time data capture, aggregation and display to drug development stakeholders. To learn more visit https://devanasolutions.com.

FOR FURTHER INFORMATION, PLEASE CONTACT:

For Devana Solutions, LLC:

Emily Wike

ewike@devanasolutions.com

For Iact Health

Felicia Irvin

Tel: 706-596-5425

firvin@iacthealth.com

Site Selection Made More Effective For Sponsors, CROs Through Disruptive Devana Solutions Technology

(CHARLESTON, SC) Oct. 19, 2017 /PRNewswire/ — Site selection for clinical trials is one of the biggest headaches for pharmaceutical Sponsors and CROs, with almost half of sites enrolling zero or one patient. Those under-performing sites annually cost Sponsors over $4 billion globally excluding opportunity costs.

Today, Devana Solutions® announced the release of MATCH PERFORMANCE, a powerful new cloud-based system to provide Sponsors and CROs with unique transparency into the timing and performance metrics of investigative sites.

“The challenge of sorting good and bad sites is difficult in a fragmented, cottage industry with very little publicly available data on research site capabilities. It is not surprising that almost half those sites enroll zero or just one patient. With industry estimates for site initiation costs at around $40,000 per site, this lack of transparency into site performance metrics is a costly problem,” explains Barry Lake, CEO of Devana Solutions®.

“Now, in the same disruptive way Uber made hailing a cab obsolete, with IGNITE FOR SITES and MATCH PERFORMANCE technology, the Sponsor or CRO gains real transparency into actual site metrics to improve trial feasibility and performance, align with top clinical research sites, reduce the cycle time and costs of a trial and, eventually, reduce the high cost of drug development.”

Sponsors and CROs currently collect data on trial site performance, but their ability to gather reliable site timing and performance metrics is mostly limited to data gathered from sites they hire for their own clinical trials. Those metrics are outdated the moment after they are gathered.

In addition, despite technological advances, it is still common practice for Sponsors and CROs to rely on self-prepared, paper feasibility submissions from sites that are often inaccurate in terms of capabilities and trial experience. These inefficiencies often force Sponsors and CROs to make assumptions on site qualifications that are not based on reliable, tangible past and current performance metrics.

The MATCH PERFORMANCE cloud technology platform addresses these problems, allowing Sponsors and CROs to align with the best research sites for each trial opportunity, by capturing and aggregating the historical and real-time performance metrics across every trial a site has completed or is running with competing Sponsor and CRO information fully blinded or de-identified.

How MATCH PERFORMANCE works

The key to MATCH PERFORMANCE’s effectiveness is in Devana Solutions’® previously launched companion technology, the recently re-branded IGNITE FOR SITES, a real-time data capture, integration and analytics platform introduced in May 2016 and used by the leading investigative sites themselves to save time and win more of the right trial awards.

IGNITE’s proprietary algorithms automatically capture, aggregate and display the timing and performance metrics of the sites on the platform. Over 150 investigative sites are using IGNITE FOR SITES to automate study pipeline, aggregate historical trial performance and track critical study information and documents with a focus on study start-up activities.

MATCH PERFORMANCE regularly synchronizes site metrics data populating from IGNITE to a secure platform used by subscribing Sponsors and CROs.  These metrics are captured instantaneously on MATCH PERFORMANCE and can be displayed and analyzed through more than 100 customized reports and easy-to-read dashboards giving instant access to important site performance measures across therapeutic indications including analysis of completed and active patient volume, contract met percentage, speed of enrollment and start-up times.

“MATCH PERFORMANCE and IGNITE FOR SITES are the leading platforms to collect, aggregate and analyze data directly from the source, clinical research sites,” added Lake.

The pricing model

At this early stage, the initial price for entry for Sponsors or CROs interested in MATCH PERFORMANCE is a commitment to purchase IGNITE FOR SITES multi-year subscriptions on behalf of a significant number of trial sites in their network.

IGNITE FOR SITES subscription model pricing starts at $450 per month for a single investigative site with two users. Multi-site and Site Network versions with five or more users can achieve per-user volume discounts based on level of customization required and access to enhanced product training and support.

FOR FURTHER INFORMATION, PLEASE CONTACT:
Emily Wike

ewike@devanasolutions.com

Medix Clinical Research Announces Partnership with Devana Solutions

(Chicago, IL) April 17, 2017 – Medix Clinical Research, a team within Medix focused on workforce solutions for clinical trials, has announced an on-going partnership with Devana Solutions focused on developing innovations to help empower clinical trial sites.

Medix and Devana Solutions® began working together after recognizing their shared passion to help research sites better understand their business and how to compete in the market.

“Medix Clinical Research’s drive to be at the cutting edge of workforce solutions and site consultation aligns perfectly with Devana Solutions®’ commitment to develop technology to help clinical research sites capture and interpret meaningful data,” said Dan Dumrauf, Direct of Medix Scientific. “Together, we’re excited to be able to offer more solutions to teams that are struggling in a complex industry.”

Devana Solutions® Ignite for Sites technology provides automated tracking of trials and contacts from study lead to completion to save time while proprietary algorithms capture the site’s timing and performance metrics enabling site managers to analyze performance and report therapeutic and operational strengths to sponsors and CROs to win more study awards.

“Medix’s site consultation professionals are experts at advising sites on operational best practices to become more efficient and grow study revenue,” said Barry Lake, CEO & Executive Chairman of Devana Solutions, “exactly matching our Ignite for Sites value proposition of saving time while winning more awards.”

For more information about Medix and Medix Clinical Research, please visit www.medixteam.com.

About Devana Solutions

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 two platforms, IGNITE FOR SITES and MATCH PERFORMANCE, to provide historical and real-time data capture, aggregation and display to drug development stakeholders. To learn more visit https://devanasolutions.com.

About Medix Clinical Research

Medix Clinical Research is committed to positively impacting lives, as well as educating and empowering sites across the United States to help advance innovative, life–changing therapies for patients around the world.  Our clinical staff provides the strategic solutions you need to advance your research mission forward.  Every site’s need is different, so whether your need is operational or compliance based, our in-house clinical research staff is dedicated to help your site build a sustainable research program.


Check us out at:

Event-Date-Location

  • EXL Clinical Performance Metrics Summit December 4-5, 2017- Philadelphia, PA
  • ACRP Conference- April 27- May 1, 2018
  • DIA Conference- June 2018
  • SCRS Global Site Solutions Summit -October 2018- Boca Raton, FL

Check out our interview with Dan Sfera from The Clinical Trials Guru

PMG Research Partners With Devana Solutions To Accelerate Growth Of Business & Mission

(CHARLESTON, SC) April 7, 2017 /PRNewswire/ — PMG Research, Inc. and Devana Solutions, LLC, today announced a long-term subscription agreement for the use of Devana’s advanced cloud-based technology across PMG’s industry-leading network of over 50 investigative site locations.

The agreement allows PMG’s integrated network of sites to adopt Devana’s Ignite for Sites platform to fully automate its operations from study lead through trial completion.

In addition to PMG’s more than 7,700 completed clinical trials, the advanced Devana Solutions® technology simultaneously tracks, aggregates and allows PMG to display and report its timing and performance metrics in real-time for all trials currently running across its entire site network.

This technology advantage, coupled with best-in-class trial management capabilities, will allow PMG Research to expand its industry leading position and secure additional trials in partnership with pharmaceutical sponsors and CROs.

Amanda Wright, Senior Director of Client Services and Communications at PMG, commented: “PMG Research has always embraced technology innovation as an important way to grow our business and to fulfill the organization’s mission of bringing clinical research to as many people as possible.

Devana Solutions® system allows for the end-to-end capture of data that will us to continue to demonstrate to CROs and Sponsors that our performance is among the best in the industry and that PMG is committed to the highest standards.”

Barry Lake, CEO & Executive Chairman of Devana, added: “PMG is clearly a leader in the site operations enterprise and we are thrilled to partner with them.

“From the first conversation, they shared Devana Solutions’ opinion that more and better data about site performance will mean that the most capable networks of sites, like PMG Research, will win more awards, leading to shorter cycle times for trials, lower costs and, ultimately, lower cost treatments for patients.”

FOR FURTHER INFORMATION, PLEASE CONTACT:

For Devana Solutions, LLC:

Emily Wike

ewike@devanasolutions.com

For PMG Research, Inc:

Kristin Kinlaw

kkinlaw@pmg-research.com

Tel: 336-608-3506

ABOUT PMG RESEARCH (www.pmg-research.com)

PMG Research, Inc. is an integrated network of clinical research facilities with fourteen hub sites located in Champaign, ILAmes, IACaryCharlotteHickoryRaleighRocky MountSalisburyStatesvilleWilmington, and Winston-Salem, NCCharleston, SC; and Bristol and Knoxville, TN. PMG has conducted over 7,700 research studies for hundreds of pharmaceutical sponsors and CROs since 1979. We have extensive experience conducting all phases of trials across a comprehensive list of conditions. Our mission is to bring clinical research to as many lives as possible while delivering unparalleled service and exceptional value to our clinical trial partners and stakeholders.

ABOUT DEVANA SOLUTIONS 

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 two platforms, IGNITE FOR SITES and MATCH PERFORMANCE, to provide historical and real-time data capture, aggregation and display to drug development stakeholders. To learn more visit https://devanasolutions.com.

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