Service Description

The CRO was contracted to perform all activities related to regulatory submissions, budget and contract agreements, site selection, site training, ongoing monitoring visits, drug import, shipment and destruction and study closure activities.

What Went Well

The CRO was very pro active in negotiating budgets and contracts, no contract came or Sponsor review. During the Quality Control Visit, very few issues were raised that were not previously identified by the CRO CRA. Study Closure occurred with no Sponsor interference and within planned timelines.

What Could Be Improved

Sites were poor selected.Sponsor had to interfere with sites to start enrollment that ended below the expectation. CRO took a long time to have a person dedicated to the trial in the Country. CRO did not act pro actively with sites to boost enrollment.

Lessons Learned from the Experience

In terms of recruitment no. CRO came back to the sponsor asking for help in negotiating with the sites to achieve enrollment target. CRO personnel is very technical but show lack of therapeutic area knowledge. Sponsor had to organize a local Investigators meeting to train all sites.