Registries Case Study 2
Challenge:
The client asked us to take over a series of ongoing programs that had moved into long-term extension. We were asked to develop a strategy for managing multiple global studies across several therapeutic areas that was process driven and cost effective. This served as the foundation for a collaborative partnership in outsourcing future long-term extension programs.
Solution:
- Provided strategic project management to utilize in-house resources for site management activities and field CRAs for source document verification
- Coordinated global resources to ensure that all study activities were of high quality and completed efficiently
- Developed training material for a ‘SWAT’ team of CRAs to be able to conduct on-site monitoring visits with minimal training
- Served as single point for site contact available in each country/region
- Tracked all CRFs and query responses
- Collected and tracked amendments/regulatory documentation Managed study supplies
- Ensured that all database lock timelines were met
- Managed all regulatory and IRB/Ethics Committee submissions
- Trained sites (new staff only) on an as-needed basis
- Facilitated safety data reporting with sponsor’s pharmacovigilance group
