How do you choose the right EDC system for your PMCF studies?

With European Medical Devices Regulation (EU MDR) now in full effect, device manufacturers are under more scrutiny to collect clinical evidence. Originally there was a lack of clarity on good Post-market Clinical Follow-up (PMCF). Now we see medtech companies working to address PMCF requirements under tight timelines to ensure they have the data required by authorities.

In the last few years, EDC tools have become available that are compliant, agile, and easily adaptable to meet the needs of PMCF. See the key components below for leveraging an EDC system for your PMCF studies.

Leveraging Agile Design

Writing and reviewing stand-alone study specifications is time consuming and can add weeks or months to the study timeline. Much of the effort and delay results from the diverse stakeholders. Veeva has a design principle that spans all products which is to automate simple tasks and make the hard tasks easy.

With Agile Design, user acceptance begins earlier, during live interactive design review meetings when the CRF design begins. As a new best practice stud team members come together in a room and online, and updates are made in real-time, with everyone seeing and evaluating the changes together. The ability to see and discuss updates motivates people to make time for in-person meetings, which in turn produces lasting decisions. Agile Design transforms a lengthy UAT process into a fast-paced, proactive activity involving all critical stakeholders.

Risk-based Real-Time UAT

Building on agile design, user acceptance begins early, in the design phase, which fosters better collaboration and decision making. Due to the cloud-based development environment, sponsors have direct access to the casebook throughout the entire build. Real-time visibility and collaboration eliminate the delays and miscommunication inherent in traditional UAT cycles.

An innovation in Vault EDC called the Study Differences Report allows data management to see any additions, omissions, or changes between studies. Using the template study as reference, companies no longer performs UAT on forms that were previously tested. Whether building a database for a new study or amending a current one, traditional UAT is a tedious process due in part to the volume of items to evaluate. Veeva’s risk-based approach to UAT also gives teams the visibility and justification to test only what’s needed. Narrowing the fields and rules for testing saves significant time and effort.

Repeat Studies Leveraging a Standards Library

Once you invest time in your first PMCF study, similar studies should be easy to build but we have lacked the proper technology to properly manage these standards and “template” studies. Clinical data standards can speed the simple PMCF studies that many manufacturers need to run and drive higher quality data entry at sites. But often, these initiatives fizzle out. It’s possible to successfully establish standards if you involve the right stakeholders, stick to what’s necessary to support study objectives, and determine when and how updates should occur. Establishing standards requires a team effort and organizational buy-in from the very top. While a small working group hammers out the proposed templates or standards, executive support is needed at the beginning to get started in the right direction and at the end for final approvals. Internal alignment is critical to success, therefore be sure to incorporate the needs of downstream teams such as stats programming and statistics.

When it comes to simple data collection for PMCF, overall endpoints and objectives are key. What data are necessary to feed your analysis? Standards should only collect what’s required to support your study objectives. Exploratory data is potentially useful, but diverts resources from critical data and places additional burden on patients and sites. Start defining your data standards with these first steps. Vault Studio provide the right library management to support managing multiple versions of your case report forms and thus reduce the overall time to get your PMCF study live from months to week or even days!

Easy Amendments and Changes

With the volume of PMCF studies that many manufacturers need to run they must be able to make simple study changes easy and fast. Outdated systems require lengthy downtime and migrations to make simple changes which there just isn’t time for with PMCF. Modern build tools make it simple to make changes. And there are error checking tools that help prevent making changes that may be detrimental to the current design or existing data.

Vault Studio allows for an underlying database design that is as dynamic as the PMCF study itself. With an architecture designed to support multiple CRF designs and make real-time changes, Veeva delivers a better EDC that eliminates the need for migrations and reduces the overall cost and time to make simple changes common in PMCF studies that are otherwise normally very simple. Using the difference report that is leveraged during UAT allows users to see what has changed between versions of the casebook, sense that nothing was changed inadvertently, and focus validation efforts. Add this to the Vault library capability and you have a win-win scenario to support your PMDF studies.

Summary

Technology has finally caught up and can provide the functionality to support the needs of PMCF studies. With the right tools and partner manufacturers can implement solutions to accelerate the work that is needed for EU MDR requirements.

Learn more about Vault Clinical Data Management Platform visit Veeva MedTech.