Choosing the Right EDC System for Pilot/FIH Medical Device Studies

25 January, 2019, by clincapture-client

The benefits of using EDC systems, as opposed to paper, in a clinical trial can be significant for medical device studies. For example, EDC system for medical device studies can help streamline data collection processes by omitting the need for monitors to visit sites for Case Report Forms (CRFs) verification, eliminate redundant double (or triple) data entries, reduce unnecessary mailings and paper use, end long-term storage usage, and alleviate much of the sponsor’s tedious responsibilities in the data collection process.

If you are running an initial pilot/FIH study, you may be wondering if opting for an EDC system for medical device studies is the best choice for you, mostly if you are running a small population study and are looking for an affordable solution. Contrary to popular belief, choosing a paper-based data management system can result in tedious tasks and be more expensive.

Reasons to use an EDC system for medical device studies:

Omit tedious and time-consuming responsibilities, especially for the sponsor.

Eliminate transcription errors as they occur.

Streamline processes with Advanced Reporting and Risk-Based   Monitoring.

Cut costs of paper-related expenses (shipping, monitors, printing, etc.).

Have access to real-time data.

It is important to keep in mind that not all EDC vendors offer the same benefits. Some vendors may charge excessive training and support costs, making it difficult to justify for smaller/simpler studies.

Things to consider when choosing an EDC system for medical device studies:

How does their pricing model work?

Does the EDC vendor charge excessive set-up fees, including high costs for support and training? At ClinCapture , we pride ourselves in being able to handle both small and large studies at 20% the cost of leading competitors. ClinCapture also offers a free support program and affordable training.

Will I have access to Advanced Reporting with Business Intelligence tools?

By having access to advanced reporting tools, companies can make better data-driven decisions and improve resource allocation. The ability to analyze and leverage operational data in real time is critical to streamlining organizational effectiveness. As part of our winter release, sponsors and CROs alike will be able to easily use actionable information from ClinCapture ’s advanced reporting with business intelligence tools.

Is the EDC system scalable for larger populations/pivotal studies?

As your study grows, you will want an EDC system that can handle complex data, while providing advanced tools. It is important to opt for an EDC system that can grow with your study.

What is the track record of the EDC system?

The ultimate goal of medical device companies is to bring their products into the market. Ask your vendors about their track record with other medical device companies. Have they been successful in obtaining regulatory approval? ClinCapture is proud to have a track record of working with companies with successful medical device approvals.

If you are evaluating EDC systems for medical device studies, learn more about ClinCapture ’s comprehensive eClinical platform. You can request a consultation here to get started.

About the author

ClinCapture provides a powerful eClinical platform that enables sponsors and CROs to rapidly build and deploy studies, lower clinical trials costs, and streamline data capture processes. Offering a host of Private Clinical Cloud® solutions, ClinCapture ’s technologies help advance the evaluation and development of drugs, biologics, and devices that demonstrate promise for the diagnosis and/or treatment of a wide range of diseases or medical conditions. For more information, please visit ClinCapture .com or follow us at @ClinCapture .