Accelerating the global development of safe and effective medical therapeutics is our mission. COVID-19 has made that more challenging than ever — but not impossible. We are adapting processes, technologies and training to move promising therapies forward in this fluid and demanding environment. Our primary goal is to maintain patient safety and oversight as we continue the clinical trials through the pandemic. This requires practical and creative solutions as we comply with the regulatory guidance in each region/country. We have established internal COVID response teams (administrative and operational) to support our project leaders with guidance and appropriate documentation across all functions. Our response teams consist of executive management, and meet several times per week/sometimes daily to make decisions quickly and roll out communications around the globe. In addition, we have mandatory weekly trainings with project leadership to ensure appropriate training and guidance on newly developed processes.
Protocol Specific COVID-19 Risk Assessment Process
We have undertaken detailed risk assessment of study protocols for COVID-19 to ensure the safety of patients and site personnel including:
- Mandatory process and documentation for each ongoing study
- Complete cross functional evaluation of protocol and COVID-19 impact
- Management of protocol-driven procedures and visits
- IP (and supplies) delivery/accountability
- Safety and efficacy variables/impact on data analysis/per patient population
Site Management and Monitoring
While COVID-19 has fundamentally altered how we monitor clinical trials for the foreseeable future, we are equipped to adapt in a flexible way. Medpace can ensure obligations for appropriate oversight and monitoring are met and provide full support to site staff while limiting the burden on site personnel who are already overwhelmed with managing the pandemic.
COVID-19 Site Management and Monitoring Plan Highlights:
- Virtual monitoring visits as frequent/more frequent than expected onsite visits
- Completion of CRA visit procedures (as much as possible)
- Easy to use tools (e.g. FaceTime) for site personnel
- Source Data portal — allows sites to upload source data securely
- Remote access to electronic medical records
We have implemented and trained CRAs on the conduct of virtual monitoring visits, including Site Initiation Visits (SIVs) and site study-specific training. A site-specific approach to monitoring is necessary as each center has its own unique policy and/or restrictions. Implementing a flexible, site-specific approach enables us to provide appropriate oversight and support. Whether virtual or on-site, visits will be completed according to Medpace SOPs to ensure proper training of study personnel on the protocol requirements and study procedures.
Heightened Site Support
Trial sites are under intense pressure during this crisis. Medpace is responding by deploying highly-qualified resources such as clinicians — who are independent of the site’s Clinical Research Associate (CRA) — to provide additional site support as needed. These individuals become a working site coordinator under Principal Investigator (PI)/Clinical Research Coordinator (CRC) supervision and can help sites maintain continuity and move trials forward.
Examples of Services:
- Virtual or home visits with patients including:
- Direct to patient shipments of necessary study supplies
- Procurement of additional supplies to conduct home visits
- Review of patient records for patient identification if the study/site is continuing to recruit patients
- Creation of teaching videos for patients
- IP delivery, IP administration, diary inputs, etc.
- Centralized patient transportation services
To accommodate virtual visits and ease the burden on sites where remote access to electronic medical records (EMR) is not permitted, Medpace has released a source module within our ClinTrak® EDC Platform. The ClinTrak® EDC Site Source Study Portal allows sites to upload source documents to a secure portal. All data is encrypted, and only authorized users can upload, view, or verify source documents.
- Enhanced remote source data verification capabilities
- EDC updates including COVID-19-related protocol deviations in patient visits and procedures
- ClinTrak CTMS enhancement to alert teams to site-adjusted policies as well as specific country guidance
- Updated Protocol and Clinical Study Report templates for COVID-19 adaptations
Our Commitment to Making the Complex Seamless
Our industry is being challenged as COVID-19 adds a new layer of complexity. We are putting forth every resource to ensure your clinical trials continue to be advanced, that our efforts do not put clinical site staff and patients at undue risk and our studies remain in compliance with governmental policies. As a full-service CRO with nearly 30 years of experience supporting Sponsors and advancing life-changing therapies, we remain more committed than ever to work by your side and to execute your studies as seamlessly as possible.
You can learn more about Medpace’s response and capabilities related to COVID-19 here.
For print version, click here.