The Situation

EVERSANA was approached by an emerging biotech company to manage the drug safety operations and safety reporting of their serious adverse events (SAEs) that would originate from their oncology clinical trials and also from the investigator-sponsored trials (ISTs). This included the need to maintain a Safety Assessment Committee Charter and conduct SAC meetings on a quarterly basis. They needed help with the development of a safety management plan, workflow process, configuration of the safety database, staff training and alignment of communication between the client, EVERSANA and the investigational sites.

The Solution

With years of clinical trial experience, EVERSANA smoothly launched the safety operations for this clinical trial project. Here’s what we did:

• Developed a safety management plan outlining roles/responsibilities and procedures required to collect/process the SAEs
• Provided SAE templates to the investigational sites and the guidance needed to complete the SAE form
• Interacted with the CRO maintaining the clinical database and guided them in the development of an SAE reconciliation plan to perform SAE reconciliation between the clinical sites and the CRO’s safety databases
• Conducted the SAC meetings on a quarterly basis, gathering and compiling the data required for the meeting

The Results

The clinical trial project was initiated in the U.S. and slowly expanded to the EU. We expanded our scope to support the clinical trial safety processing for the EU cases and also submit the cases to EMA’s Eudravigilance system. Safety staff members were trained to support the EU and US case processing. EVERSANA also managed the translation of the documents received in a foreign language.

The client continues to work with EVERSANA as they initiate new clinical trial studies and as more clinical trial sites open up. They are pleased with our commitment and flexibility to meet their changing needs.