Efficiently conducting a worldwide phase 2 clinical study with multiple partners

100%

Timeline compliance (submissions, FPFV, CSR, …)

225 patients

Recruitment target achieved!

Background

Wishing to evaluate the efficacy of a treatment for Non-Alcoholic Steatohepatitis (NASH), this client, a French biopharmaceutical company, entrusted us with this full-service Phase II study, for which the results were highly anticipated and had a major interest for the investors

Challenge

Various challenges were inherent in this study:
1. Complexity of the Study: 71 centers, 3 continents, 3 central labs, standardization of procedures
2. Compliance with the regulations of the 16 countries
3. Difficulty in recruiting patients (requirement for biopsy history and centralized review)
4. Pandemic: Lockdown impacting monitoring activities during database lock
5. Data cleaning & Intermediate analyses (for presentation to investors) involving very tight timelines

Approach

An adapted response has been put in place to meet each challenge:
1. Study team organized around an overall Project Manager and several Study Coordinators
2. Global regulatory management through local contacts/relays
3. Close follow-up of the patient recruitment with implementation of booster calls, protocol amendments (simplification of inclusion/exclusion criteria), and extension to new centers and countries
4. Prompt adaptation of the Monitoring plan, allowing the use of videoconferencing during the lockdown, to maintain the database cleaning delays
5. Anticipation: data cleaning by batch allowing to respect the schedule

Key results

Excellent synchronization of the activities carried out on the 3 continents: respect for timelines and the expected level of quality

Target recruitment of 225 patients achieved, despite restrictive inclusion/exclusion criteria and numerous competing studies

Efficient adaptation to the lockdown: advisory role (operational & regulatory) to the sponsor on actions to be implemented, and justifications to authorities.

Benefits

This Phase II study has been a success, thanks to its good management in full-service: the patient recruitment objective has been reached within the timelines, and with a sufficient quality for statistical analysis. And this despite the pandemic and its lockdown, as well as the multi-continental dimension. The sponsor is satisfied and has been able to communicate in due time to its investors.