Three Critical Factors Essential to the Evolution of Clinical Research Sites in the EU

The clinical research industry is evolving, especially when it comes to the adoption of technology. One of the first steps in making an impactful technology decision at your organisation is understanding the factors at play within the industry, including regulatory bodies, technology vendors, sponsors/CROs, research sites, your peers, and technology innovation at large.

This blog focuses on the critical factors at play within the EU: Transitioning from paper to digital processes, reducing complexities when working with Sponsors and CROs, and reducing regulatory anxiety. If you’re interested in the state of the industry at large, check out the Florence Annual State of the Industry Survey, which focuses on the areas clinical research sites are investing related to technology in 2023, including site enablement technology.

The shift from paper to digital within clinical research is already happening, and it’s happening quickly. You have the choice to make the jump now, or get pushed into it later. We encourage you to be a leader within the technology shift and be a champion for change within your organisation. 

One of the keys to improving your way of working at your site is to ensure you seek out site-first solutions that are built with a true understanding of your specific challenges. Utilising a site enablement platform ensures an intimate understanding of the day-to-day workflows of site operations team members, like managing documents electronically, and working with electronic signatures to replace handwritten ones.

There is an increasing complexity associated with document archival – the number of studies being conducted, as well as the extended period of time required by regulatory agencies, makes it increasingly difficult to keep documents archived, which cannot be effectively (and compliantly) done with filing cabinets and binder rooms.

The challenge of keeping up with rooms full of paper binders won’t go away by itself. By eliminating the need for paper, you remove duplicative processes, enable remote monitoring capabilities, save time and resources, all while keeping documents safer and more secure, just to name a few.

Working with sponsors and CROs can be complex and cumbersome, but it doesn’t have to be. Did you know sponsors and CROs now prefer to work with research sites who have strong internal software platforms?

Direct site access and eTMF integration with site-based platforms are replacing previous trends of trial sponsors and CROs deploying site portals for document collection. This is great news for sites because it puts you in greater control of your processes and workflows while also allowing you to benefit from unprecedented connectivity with sponsors and CROs, whilst maintaining compliance at all times. 

The efficiency gained from this direct connectivity is now forcing sponsors and CROs to reevaluate the sites they select to partner with, which allows you to broaden the scope of research you are able to participate in. In addition, sites are proving to gain more ROI through site enablement technology adoption. 

Regulatory bodies, often known for hindering technology adoption, are themselves making changes internally to both respond to and encourage the advancement of technology.

This acceleration is apparent when noting that the adoption of ICH GCP E6 Revision 2 took 13 years from Revision 1 – however, the conversations about ICH GCP E6 Revision 3 are already in discussion to account for rapid technological transformation.

With the adoption of the General Data Protection Regulation (GDPR) now completely ingrained within Clinical Research, personal privacy has become a commonplace in technology applications. If you would like to learn more about GDPR and clinical trials, please visit our GDPR guide here.

In 2019, the MHRA had 41 audit findings related to essential document collection and storage alone (3 of them critical findings). An electronic system with audit trails, access control, electronic signatures, and data blinding capabilities makes it easy to avoid these types of audit findings.Florence’s mission is to enable research sites to do their best work without spending all day stuck in technology. On March 22nd, we invite you to join us for a webinar where we’ll go deeper into how you can embrace technology and drive change within your organisation – register here.