Service Description

Monitoring and full study management from site selection, investigator identification and management to close out activities for a phase 3 trial in Follicular Lymphoma.

What Went Well

PPD have an excellent senior liaison manager. Issues could be dealt with at a senior level in a friendly and engaged manner. They were also very responsive to requests for changing the sites involved in the trial. The finances were updated very regularly with contract amendments and change orders.

What Could Be Improved

Site selection was not done well. Many of the sites did not recruit a single patient and needed to be replaced at significant expense. Reports regularly came from the sites that the CRAs were not helpful and we also found some difficult to work with at a country level. PPD place a competing trial at the same sites as our trial which we felt significantly hindered recruitment - but this was dealt with properly when raised to their senior management.

Lessons Learned from the Experience

We learned the value of building the relationship with a CRO at all levels in the organization. Many issues got "stuck" at a low level which were rapidly resolved once their senior management was engaged. we would also start the relationship at the country level earlier so that we could play a proactive part in site selection and avoid later delays and change orders.