Case Study Background:
A small startup company needed to meet a very aggressive, 12 month enrollment period for two complicated Community Acquired Bacterial Pneumonia (CABP) protocols which totaled working with 12 CRO’s, 36 countries, 291 sites, 1,238 patients and 40 vendors. Typical CABP trials allow 24 months enrollment to incorporate northern and southern hemispheres.
There was very little room for errors – one patient, one site, one miscalculation could force complete re-work causing delays that could not be made up. The coordination of multiple countries with multiple regulatory environments and timing issues was of major concern.
The sponsor knew that InClin had a wealth of experience in managing CABP trials and called on InClin experts to join their clinical team to manage the trials in order to meet the very aggressive enrollment timeline.
- Start the planning from LPI and work backwards
- Select regional CROs with extensive geographic and local regulatory experience
- Operate under the caveat “Tell us what is real, not what you think we want to hear”
- Build trust and relationships within the team so that if problems arose team members knew they could count on each other
- Gain commitment to the timelines
InClin’s Actions Taken:
- Conduct 3-day, face-to-face, intensive planning session with all the key players
- Build an project plan that ranged from broad strategy down to the exacting detail of individual sites, individual patients
- Manage to well defined study timelines
- Assess and define capabilities and resources to meet timeline
- Develop per county, site, and patient plan to achieve goal
- Global WebEx training for ALL team members
- Daily status/tracking reports
- Define communication plan from site level to senior management
- Regional teams communication plan
- Data management communication plan
- The trial was delivered on time
- 5 EEU / FDA site audits and no 483 issued
- Successful sponsor audit
- NDA and EMA approvals