Accelerate the clinical validation of an anti-Covid treatment, thanks to an agile data management

<4 weeks

Development of 2 eCRFs

<1 week

Database lock (Phase I) & go-lives of 2 studies (Phase II)

Background

Our client, an innovative biotech company that develops a product neutralizing the SARS-CoV-2 virus, and its variants, asked us to manage the Biometry for its phase I and II studies.

Challenge

The client entrusted Keyrus Life Science with all Data Management, CDISC Transformation, and Biostatistics activities for Phase I & II studies. The main challenge was to chain the database lock of the Phase I, and the launch of 2 Phase II studies ('mild to moderate' Covid & 'severe' Covid), over a very tight timeframe of just 1 month.

Approach

To match the client's ambitious calendar, Keyrus Life Science mobilized a multidisciplinary and very experienced Biometry team, and partnered with a very well-known EDC provider - Dacima -, to develop, beforehand, the eCRFs of the 2 Phase II studies. Following this, in just 1 week, Keyrus Life Science managed to finalize the Phase I (Data Review Meeting, Database lock), and launch the 2 Phase II studies, including the protocol and eCRFs amendments required by the client.

Key results

End-to-end design of 2 efficient eCRFs, on Dacima, in less than 4 weeks.

Go-live of the two phase II studies, with the protocols and eCRFs amended as required.

Timelines achieved, in line with the initial calendar

Benefits

Thanks to its preparatory work, and the agility of its teams, Keyrus Life Science was been able to launch both Phase II studies, within the expected deadlines and with all the modifications to the protocols and eCRFs incorporated, therefore avoiding any potential delay or added cost.