Managing efficiently a large cohort RWE study, thanks to dedicated apparatus

<5 days

average time before data monitoring

90%

exploitable visits

6 months

time between the LPLV & the Clinical Study Report

Background

Our client is the french subsidiary of a major international pharmaceutical company (Top 5), operating in more than 150 countries, in a wide variety of therapeutic areas, in particular Oncology, Cardiology and Ophthalmology. Wishing to set up a RWE study on the french market, this client chose us for our agility and capacity to adapt, essential for such a study.

Challenge

The objective of the study was to better understand 'in real life' care management habits for patients suffering from heart failure, and referred for the first time/rarely to their cardiologist. Such a RWE study was performed to help the client optimizing its marketing strategies, in conjunction with healthcare professionals.

Approach

To achieve this objective, a large-scale national multicenter study (150 centers, 1600 patients) has been set up. Keyrus Life Science carried out all the activities required for the study: regulatory submissions, recruitment of investigator cardiologists, follow-up of patient recruitment, remote (or not) monitoring of the data, data management & statistical analyses, clinical report and presentation of the results.

Key results

Selection of the 150 most appropriate investigator cardiologists for the study (among 4500 contacted)

Sufficient patient recruitment to statistically evaluate the primary objective, despite the epidemic context that impacted the study

Management of the monitoring activities in compliance with the schedule, thanks to agile processes adapted to the study challenges (dedicated CRAs, TEC visits, mixed paper-electronic CRF)

Benefits

Satisfied with the overall management of the study and the results obtained, the client emphasized the performance of the Keyrus Life Science teams, both in terms of setting up a structure adapted to the study recruitment goals and in response to the Covid context. The better disease understanding, gained throw this study, helped the client building an optimized market access strategy.