The Making of an MVR with Microsoft Office Smarts and an Iron-Clad Audit Trail
Regulatory authorities require clinical trial progress to be monitored. The site visit report, known as the Monitor Visit Report (MVR), is where sponsors provide evidence that all regulated activities have been completed along with documentation of the outcome. These reports are open to regulatory inspection at any time during a study, as well as after, and even post product approval.
Recognizing their importance in clinical trials, BioClinica set out to give sponsors a different kind of MVR − one that would answer questions posed by regulatory authorities and the sponsor itself. Ideally the solution would increase accuracy and efficiency in the site monitoring process, helping drive down costs associated with monitoring, estimated by some organizations as consuming 40 to 60 percent of their clinical trial budget and totaling millions of dollars.
MVR, On a Mission
Working with a diverse group of 15 companies, BioClinica gathered input from research organizations ranging from smaller pharma organizations, to the largest in the industry. The team studied various use cases and requirements, including offline completion of MVRs. Also considered were different monitoring scenarios, sometimes handled internally and other times outsourced to CROs.
After five years of testing in the field and fine-tuning, the team introduced for general availability an MVR integrated with the BioClinica "Microsoft Office-Smart" OnPoint CTMS (see Part 1 of this blog for more information). It leverages Microsoft Business Intelligence (BI) tools and has native connection with SharePoint, the life sciences' industry standard. Built-in robust reporting and metrics capabilities deliver added value beyond that of a static MVR design. This includes important performance metrics so that organizations can improve their monitoring and operational efficiency going forward.
Realization of Effort
The intensive work that went into development was recognized in the form of a Microsoft Life Sciences Innovation Awardin 2012. More important than receiving this honor was the creation of an innovative tool that saves significant time and effort in completing site visit reports, therefore reducing costs (potentially by millions of dollars), while eliminating issues surrounding data accuracy and traceability of regulated clinical trial activities.
Since its development, BioClinica's MVR has been further enhanced and is now available with a full library of easy-to-use and configurable templates. This makes optimal use of site monitors' time, while providing the audit trail for regulatory authorities and discerning sponsors alike. Of course our customers are able to continue using the same templates, giving monitors a familiar format and instructions. Today our MVR is a mature and well-tested solution used by research organizations around the globe.
As a clinical solutions specialist for eClinical, one of my favorite tools to demonstrate is the MVR solution and once you see it, I know you'll see why. If you'd like to check it out for yourself, contact me via email at firstname.lastname@example.org, call me at (206) 769-7886, or fill out a Contact Us request online.
If you'd like to see OnPoint in action, I'll be demonstrating some great functionality in an upcoming webinar CTMS/eTMF Interoperability: Taking Clinical Trial Data beyond Documents. Until then, I'd love to hear from you on site monitoring, CTMS and related topics so don't hesitate to reach out.