WCG recently introduced its Velos eResearch eXpress™, a turn-key solution for sustainable advancement and growth of clinical research sites. They purport the solution to be an “out-of-the-box cloud-based solution that enables clinical research sites to centralize and manage their research activities on a single automated technology platform.” WCG acquired Velos at the beginning of January 2019 as it continues to add capability to its private equity-backed consolidation strategy.
What is Velos eResearch Express?
Fundamentally, it is described as a clinical trial management system (CTMS) designed for smaller institutions and independent sites, which do not have the budget, resources, and scale required to implement the costly, large, and complex systems offered by other CTMS vendors.
They tout that the product is pre-configured version of the industry-leading Velos eResearch solution, an enterprise platform used in the market for clinical research management, financial management, patient management, study management, calendaring, and reporting.
What is Different About Express?
They report because of the pre-configured capabilities and “cloud-based hosting model” it can be implemented in days rather than months. The obvious implication is that it is priced in a more economical way for small research sites.
Who developed the Product?
The product was developed by WCG Velos, the trusted provider of clinical trial management solutions that increase productivity and efficiency of clinical research. WIRB acquired Velos.
WCG—Private Equity-Led Consolidation around a Central IRB
WIRB-Copernicus Group (WCG) Clinical Services Division (WCG Clinical) acquired Velos eResearch business line. Velos was a leading provider of clinical trial management solutions that competed against firms such as Forte Research, which represents the market for clinical research site-side technology vendors. It should be noted that there is a whole other class of CTMS and eClinical software product targeting the industry/commercial sponsor biopharma.
WCG acquired Velos to augment its portfolio of products and services to position and sell site-side CTMS. Velos links the administrative, financial, and regulatory elements of clinical research on a single, adaptable, easy to use technology platform making the execution of research more organized, more manageable and more profitable for institutions.
Internet based, the Velos eResearch was designed to simply the management of institutional research by linking study status, patient enrollment, calendars, budgets, billing and electronic data capture (EDC).
Velos eResearch was co-founded by John S. Mcllwain in 1996.
Integration with WCG SiteReady™
WCG is offering a bundled offering where Velos eResearch eXpress is combined with their SiteReady platform for an expansive, end-to-end, fully-integrated solution offering sites competitive advantage. SiteReady WCG purports combines several of the company’s unique and powerful site-specific services including research management, performance benchmarking, contract and budget development, site-based patient recruitment, and study acquisition. The goal of course with any suite of software and service combinations is to make the research site more efficient and profitable. WCG claims that SiteReady clients are enjoying annual growth rates from 6% to 16% but this claim must be verified through systematic reference checks.
Site Performance including Continuous Improvement & Metrics
Research sites run the gamut from highly sophisticated in systems and processes to fairly immature-and the par to the world they operate in can be a factor in system and process maturity curve. TrialSite News principals works with sites world-wide, from the largest academic medical centers and government operations to small one location commercial sites. Moreover, new research site models emerge for example where specialized firms that bring turnkey GcP compliance and clinical trials know-how partner up with physicians networks with no clinical trials experience.
Regardless of model many sites are not fully data-driven which does represent risk—operational, regulatory and clinical risks can result.
Jill Johnston, President Study Planning and Site Optimization Division for WCG, who helped build up Veeva’s juggernaut moved to WCG and notes Many independent clinical research sites don’t track their operational metrics” and continued “Either they’re not sure what to track, or they lack the ability to accurately capture the data. Without quality metrics to share with biopharmaceutical sponsors, sites can struggle to develop business, acquire new studies and enroll patients. Velos eResearch eXpress helps sites to centralize the management and documentation of their trial-related activities, run their programs more efficiently, increase productivity, and improve communication. It also gives them the ability to measure and track critical data, which they can use to attract more sponsor-funded research.”
Clinical Investigator Site Maturity Curve: There Must be a Culture of Quality, Safety and Productivity in Place
TrialSite News principals have significant experience interfacing with clinical research sites as mentioned previously. We must emphasize that the present clinical research site space is undergoing profound shifts as the nature of the commercial sponsor focus changes (e.g. precision, targeted medicines, rare disease; emergence of emerging biopharma, etc.) and we have found a range of challenges at the site level from a “CYA” checklist-driven reactive quality culture to a lack of competency in matters quality assurance and true risk-based planning to upheaval with streams of private equity-led capital flowing into site consolidation and roll-up plays.
Software can be very helpful but the research organization must have a vision, strategy, and business-driven plans to go from “as is” to “to be” states in a methodical and systematic way that minimalizes disruption to the present institution.
Regardless of what technology you select, we recommend a thorough understanding of your present business and based on vision and strategic planning comprehend the direction you are headed—validate your planning with experts in the field that have the “vocational certainty” to ensure you are on the right path.
When you review different software look at what most supports your organization rather than trying to shoehorn your organization into the parameters of the software. Take the time to do things right. It will pay great dividends whether you are a small commercial site, part of a non-profit institution or a division or department in a large health system or academic medical center.
WIRB-Copernicus Group (WIRB)
Built upon a 50-year legacy of ethical review, WIRB has grown to a private equity -financed powerhouse clinical research services and technology vendor—commanding a suite of clinical services and technologies to help organizations involved with clinical research to maximize speed and efficiency in the clinical research endeavor.
Call to Action: Are you looking at various site-side technologies? Definitely include WIRB in your list of vendors—but make sure you have a list and that you not only do significant due diligence but that you also understand your own research site operation’s maturity—where does it sit in the clinical research site maturity curve from an operations, performance, and quality benchmarking perspective? This is critically important. We know some extremely competent professionals at WIRB (Ms. Johnson being one of them), so undoubtedly they have a depth and understanding of clinical research systems and processes but also understand vendors must ultimately satisfy shareholders and sell. So, also consider independent parties to assess your current maturity operationally, etc. Your research site will need to be on a true continual improvement path to remain competitive. Understand where you sit in the Clinical Investigator Maturity Curve.