Case Study

A small Pharma company needs help with sponsor oversight for a clinical trial of 600 patients, conducted in 9 countries, at 100+ study sites.

A small pharmaceutical company (10 employees) had a single compound in several clinical trials for different indications. Clinical trial management and monitoring was outsourced to one large CRO and two small CROs with no clear-cut plan in place for coordinating efforts of the various other vendors providing required services (e.g., interactive voice/web response for clinical supply distribution, central clinical laboratory, ECG vendor, meeting planner, etc.)

Scope



After contracts were signed and start-up of clinical trials was underway, Cogent Pharma was asked to provide a virtual team to serve as an extended management and coordination team for the pharmaceutical company. The Cogent Pharma team partnered with the CRO and other vendors to ensure appropriate sponsor oversight was provided from study start-up through database lock and reporting.

Methodology

The Cogent Pharma team reviewed all vendor contracts to understand the scope of work which was outsourced and to identify any potential gaps. Roles and responsibilities were then established in concert with the client, CRO and vendors. Standard tracking tools and processes were implemented to help monitor the timeliness and quality of study activities and to ensure GCP/ICH compliance. Countries and sites were prioritized based on ability to complete the required steps enabling drug shipment and start-up. Patient enrollment was monitored against site enrollment plans and CRO monitoring visits and recruitment and retention strategies were implemented. Data quality was reviewed on an ongoing basis to identify any opportunities for (re)training. Cogent Pharma Consulting planned and implemented worldwide site communication webinars to ensure that Investigational sites remained motivated and informed throughout the trial. Throughout the clinical studies, project plans with baseline and actual milestone dates were maintained and reviewed against the contract to assess potential delays and potential contract scope changes.