Medrio

Technology has enhanced operations across all industries, including clinical research. But as eClinical software becomes more sophisticated and widespread, users are faced with more options than ever before. How can they ensure they’re getting the most effective solution for their particular needs? Check out Medrio’s free guide to find out.

 “Organizations conducting clinical trials have been capitalizing on the advantages of electronic data capture (EDC) for years, and are now leveraging additional technologies such as eSource, ePRO, and eConsent,” explains Fred Martin, Vice President of Engineering and Product Management at Medrio.

He notes that as these technologies become more sophisticated, organizations must take great care to determine which system is best equipped to ensure speed, security, data accuracy, regulatory compliance, and cost-effectiveness.

What to look for

To ensure the quality and integrity of the data that is collected in clinical investigations, there are a few fundamental safeguards for eClinical vendors to have in place to ensure they are operating safely and are compliant across international borders. Check with your local management team, but Martin recommends ensuring that any vendor under consideration can provide:

  • Local compliance;

  • Secure data transport;

  • Authentication;

  • Security measures to help ensure the authenticity, integrity, and privacy of data in transit;

  • Assurance that the platform encrypts and authenticates all data in transit at one or more network layers when data moves outside physical boundaries not controlled by the network.

An essential capability

While eClinical technology has advanced by leaps and bounds beyond its early days, one challenge continues to confront users.

“Patient data is captured by multiple systems that don’t integrate well,” says Martin. “There are numerous reasons for this, from businesses not wanting to partner, to standards not being adopted, and to the burden of keeping up with regulatory priorities.”

While eClinical platforms provide sound benefits on their own, their benefits are “compounded when coupled with other systems,” explains Martin. Combining EDC with eSource, ePRO, eConsent, CTMS and other systems makes organizations much more powerful and efficient. That’s why EDC vendors are partnering with multiple source data systems and innovating on their own.

Integration could even unlock the ability for eClinical technology to pull essential data from systems not traditionally associated with clinical trials, such as mHealth applications, wearable devices, and electronic health records (EHRs). “There is an array of ancillary systems that can be beneficial to integrate,” says Martin. “EHRs are desktop systems that are powerful and beneficial in many ways, but systems that capture the data at the point of patient interaction, like eSource, are what will transform the marketplace.”

Ultimately, organizations should be aware of the differences across systems, as not every EDC has the capabilities that today’s clinical trials demand.