From study protocol to Clinical Study Report in Covid-19 environment

The beginning of the global pandemic coincided with many Clinscience CRO trials being in their start-up stage. In this post, we would like to highlight our capabilities in delivering study milestones despite restrictive and unprecedented circumstances. As just one example case, we would like to present our customer Phase 4 trial in the andrology and urology therapeutical area which was contracted to be performed in an expedited manner. Its start-up timelines to the full extent overlapped with the first wave of COVID-19 in Europe.

Despite the noticeable slowdown in Ethics Committee and Regulatory Authority meetings/authorizations, their understandable shift of focus to COVID-19 trials and closures of diagnostic (ECG) sites in selected study cities and sites, we managed to obtain all relevant approvals and secure the active study sites. During the 7 months of the project duration, we succeeded in delivering the full scope of contracted services ranging from the study protocol development and other study relevant documentation, trial registering, engaging and contracting sites and investigators, together with performing monitoring visits and close-out visits. Our efforts resulted in finalization of the Clinical Study Report development.

In addition, despite the safety restrictions across Europe and increased anxiety among patients about  SARS-CoV-2 infection , Clinscience accomplished enrolling  4% above the agreed patient enrollment target before the end of the recruitment deadline.

We are proud of our study team and its achievements, as well as appreciative of our Clients continued investment in medicine expansion and inviting us to be a part of it.

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