Increasing compliance for global medical coverage for clinical trials

Hugh Devine1, Stephen Ferrell1

1Promedim UK

Objective

Insu cient medical oversight is a common finding in regulatory inspections. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) requires that medical oversight be ‘readily’ available.1

Previous best practice relies on a paper rota or pager system or handing around a single mobile phone with regulators checking paper testing documentation at audits.

We set out to enable sponsors and contract research organisations (CRO) to demonstrate an audit trail and to learn how compliance and e ciency can be improved in provision of 24/7 medical monitoring, whilst having a user-friendly solution for on-call study physicians.

Method

We looked at the problem and designed a solution with technology, compliance and usability for all parties in mind i.e. provision of high utility for sponsors and physicians alike whilst providing a continuous audit trail.

As a 21CFR part 112 and Annex 11 compliant3 cloud-based solution the technology allows management of study physicians who can log in and out depending on availability and can access the latest study documentation remotely through an iOS or android app.

Results

This cloud-based technology and associated medical services have now been utilised in global studies with over 1000 patients worldwide.

Case study 1

An innovative biotech company, developing new medicines in the critical care setting, required immediate medical helpline support for investigators in a complex study. The support was focused on enrolling patients and helping to correctly titrate the study drug. This 24/7 solution integrated the extensive company team with additional external medical resources to support sites around the clock on 3 continents. This enabled potential patients to be assessed by the sponsor in real-time and drug titration to be managed in collaboration with the sponsor. The technology allowed coordination of the medical support team from the sponsor together with a CRO to ensure no calls were missed despite very high call volumes.

Case study 2

Cloud-based app

Site

Conclusion

A technology enhanced medical monitoring solution can supplement in-house medical resource for global studies allowing;

• Physicians to have easy to access study documentation through an app.

• Sponsors to have visibility of the medical resource whilst ensuring a continuous audit trail to assure GCP 24/7 medical coverage.

References

A small biotech company with limited medical resource was starting a global study in a gastro-intestinal indication. They required their Chief Medical O cer to be supported by externally contracted medics to ensure global, round-the-clock provision with maximal cost e ectiveness. The continuous medical coverage was demonstrated through instant reports accessed through the app.

1. www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM073122.pdf (Accessed March 2017)

2. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11 (Accessed March 2017)

3. http://ec.europa.eu/health//sites/health/files/files/eudralex/vol-4/ annex11_01-2011_en.pdfcfm?CFRPart=11 (Accessed March 2017)ww