Pharmacovigilance Support for Clinical Trials

Safety monitoring and management starts early in product development, and is a requirement to every clinical trial (CT). It provides valuable information to the pharmaceutical company during the introduction of a new medicinal product to the market, and ensures the safety of all subjects and consumers.

The safety data obtained will help identify the product safety profile, and can be used for decisions on additional research and development regarding posology, administration route and method, populations, indications, warnings and precautions, contraindications, pharmacodynamics, and pharmacokinetics. The benefit-risk ratio is expected to be continuously improved, monitored, and updated accordingly.

The submission to the competent authorities (CAs) of all suspected unexpected serious adverse reaction (SUSAR) reports associated with the use of the developmental medicinal product (DMP), occurring during or after its administration, is an obligation of the CT’s sponsor. The applicable ethics committees and investigators should also receive communication of all SUSARs that occur. Local regulatory requirements in each trial territory should be reflected in the activities procedures to assure compliance.

At Med Communications, our pharmacovigilance (PV) team provides full support in case processing activities, including data entry in the safety database, MedDRA and WHODrug coding, case narrative writing, quality and medical reviews, follow-up requests, expectedness assessment, handling standard reporting forms, and support regulatory submissions. We create and implement procedures that will fit the characteristics of the CTs, territory, and stakeholders involved. Learn more about these services on the Case Processing page.

Our PV team also handles the authoring of periodic development safety update reports (DSURs), which include description of the actions taken for safety reasons, changes to reference safety information, inventory of the CTs, estimated cumulative exposure, all newly available safety information received for the DMP, evaluation of all serious adverse reactions and events, significant findings from the studies, safety findings from marketing experience (if applicable), non-clinical data, literature, lack of efficacy, evaluation of the risks, and benefit-risk considerations. See the Aggregate Reports page to learn more about these services.