Request from the sponsor
A re-certification of Sponsors product was needed. To be able to request this, the sponsor needed to collect data retrospectively in several European countries in several investigational sites.
Challenges that were identified by the Sponsor: Considering the busy schedule of their investigators and sites, the Sponsor asked us to find solutions to support the sites with the data collection to ensure timely data collection and submission of their dossier.
Solution
As our site support service was piloted 2 years before this assignment, we knew that our unique approach would help not only the investigational sites but also the Sponsor to capture all the data that was needed. Sites that were able to enter the data in the EDC themselves were support ed by our clinical CRAs to ensure quality of the data.
Sites that were not able to enter the data due to time constraints or shortages of staff, were working together with the site support organization. The site support liaison was able to have access to patient health records, ensuring patient privacy and respecting the GDPR, and enter the data in the EDC. At the same time, with the built in quality procedure, the team was also able to guarantee the quality of the data.
With regards to the regulatory of these type of studies, our regulatory team was able to perform the submissions and ensure all local guidelines were respected.
In this approach we combined our strengths: Site Support Liaisons and CRAs/CRA Liaisons to ensure the timely collection of data but also the quality of the data.
Outcome
Data was timely available, sponsor was able to submit the dossier timely and received re-certification within a few weeks after submission.