Expert pharmacovigilance support for clinical trials
Every clinical trial requires safety monitoring and management, beginning early in the product development life cycle. The data obtained during safety monitoring help with product safety profile classification and also help guide the course for additional research and development regarding posology, administration route and method, populations, indications, warnings and precautions, contraindications, pharmacodynamics, and pharmacokinetics. Safety monitoring and management thus contribute to patient safety in both the short and long term.
Clinical trial sponsors are required to submit all suspected unexpected serious adverse reaction (SUSAR) reports associated with the use of the developmental medicinal product (DMP), occurring during or after its administration, to the competent authorities and other applicable ethics committees and investigators. Sponsors must also abide by local regulatory requirements in each trial territory to assure compliance.
Med Communications’ pharmacovigilance team is highly experienced in supporting safety monitoring and management activities for clinical trials. We offer case processing services at all stages, including safety database data entry, MedDRA and WHODrug coding, case narrative writing, quality and medical reviews, follow-up requests, expectedness assessment, handling standard reporting forms, and regulatory submissions support. We tailor our procedures to the unique characteristics and requirements of the clinical trial, territory, and stakeholders involved. Learn more about these services on the Case Processing page: https://medcommunications.com/services/pharmacovigilance/case-processing/.
Our pharmacovigilance team can also assist with the creation of periodic development safety update reports (DSURs), which describe actions taken for safety reasons, changes to reference safety information, clinical trial inventory, estimated cumulative exposure, all newly available safety information received for the DMP, evaluation of all serious adverse reactions and events, significant study findings, 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 (https://medcommunications.com/services/pharmacovigilance/aggregate-reports/) to learn more about these services.
Contact us to discuss how we can meet your clinical trial-related pharmacovigilance needs: 877-477-0977 or https://medcommunications.com/contact-us/.
