Service Description

iV is contracted to manage and international 9 country 135+ center Phase 3 Ovarian Cancer trial. iV is to manage country regulatory and IRB/Ethics submissions including 1 central IRB in the US. It manages XUS contracting with sites and vendors (eg local labs, ancillary drugs, radiology, cardiology) as required. iV manages clinical operations and safety submissions and acts as local sponsor in countries so requiring. It assures appropriate data clean for IDMC and other data cuts and reports to regulatory agencies as required.

What Went Well

iV has performed generally up to expectations. Country managers have done well. The study is pretty much on target. Project management is generally on point and timely.

What Could Be Improved

Given the mantra that there is no such thing as a good CRO, only less bad ones, so far the experience with iV has been pretty much less bad. The conglomeration of 3 companies into one has presented challenges, with issues popping up unexpectedly particularly as re legal entities and contracting. Allocation of personnel has been an issue, with occasional lapses in appropriate focus compounded by turnover in personnel. Additional time needed to catch up or remediate often shows up as proposed scope changes.

Lessons Learned from the Experience

It is very difficult for a Sponsor to both partner with and oversee a CRO; early overoptimism results in later frustration, disappointment and compensatory micromanagement. Individuals at iV have shown insight and their experience and input have been highly valuable. Especially in startup, having country experts as opposed to regional management is a major advantage. Having managers dedicated to the project (only) and not covering more than one is highly valuable. Proper balance between partnering and managing must be set early and be flexible as CRO strengths and weakness appear.