Pharmacovigilance in Clinical Trials: The Sponsor's Obligations

What the regulations require, what we handle for you

A clinical trial is subject to safety monitoring—quite the contrary. From the moment the first patient is enrolled, the sponsor is responsible for organizing the trial’s safety monitoring, evaluating serious adverse events reported to it, and submitting regulatory reports on events that meet the applicable criteria. At CLINACT, this responsibility can be delegated to VIGILANCE360, our division dedicated to pharmacovigilance for clinical trials.
Learn more about our full range of expertise on the Vigilance page.

The sponsor of a clinical trial must establish a system for the continuous monitoring of serious adverse events (SAEs) occurring in enrolled patients, analyze their causality and whether they are expected or unexpected, and report them to the competent authorities within strict regulatory deadlines, generally ranging from 7 to 15 days depending on the severity of the case.

Every serious adverse event (SAE) that occurs during a clinical trial triggers a specific management process, guided by Good Clinical Practice and Good Pharmacovigilance Practice:

• causal analysis: evaluation of the relationship between the observed event and the use of the experimental product
• assessment of whether the finding is expected or unexpected, based on the information already available in the investigator's brochure
• data entry and coding according to the MedDRA dictionary, using the dedicated pharmacovigilance software (Safety Easy)
• requests for additional information from the developer's ARCs to fully document the case
• Monitor the EIG until its completion, updating the assessment as new information becomes available

This methodological rigor determines both the scientific quality of the evaluation and compliance with the deadlines set by regulations.

SUSARs are reported electronically via EudraVigilance. Other safety information requiring regulatory reporting—including certain unexpected events that affect the benefit-risk balance or urgent safety measures—is submitted in accordance with the procedures set forth by the CTR, specifically via CTIS.

In addition to providing ongoing reports, the sponsor must also submit an Annual Safety Report (DSUR), which summarizes all safety data collected over the past year and forwards it to the authorities and ethics committees. Overseeing the Data Safety Monitoring Boards (DSMBs) is also part of the sponsor’s safety responsibilities, when required by the protocol.

The processing of adverse drug reactions involves several complementary roles: case managers for receiving and prioritizing cases, pharmacovigilance officers for data entry and coding, pharmacovigilance physicians for medical evaluation, and quality control specialists to ensure compliance with procedures.

One specific aspect of safety monitoring in clinical trials warrants special attention: the regular reconciliation of the safety database (Safety Easy) and the data management database (CRF) to ensure that all serious adverse events (SAEs) recorded by investigators are properly captured in the safety database, and vice versa.

Entrusting a CRO with the pharmacovigilance for a clinical trial—one that also handles data management, biometrics, and regulatory affairs in-house—simplifies database reconciliation and streamlines communication between teams. This integration, unique to the MultiHealth Group ecosystem, reduces processing times and minimizes the risk of discrepancies between clinical and safety data.