Pharmacovigilance Services in Clinical Trials
At OC Vigilance, we offer specialized pharmacovigilance services for clinical trials, ensuring rigorous patient safety monitoring throughout the clinical development process. Our team of experts collaborates closely with study sponsors and research centers to identify, manage, and report any adverse events or safety signals that may arise during clinical trials, in compliance with current regulatory standards.
In our company, we conduct rigorous clinical trials to determine the safety and efficacy of medicinal products, investigating their clinical and pharmacological effects, as well as possible adverse reactions.
Our services include
- Clinical Trial Pharmacovigilance Consulting
We provide support in drafting and/or updating procedures for implementing a pharmacovigilance system for clinical trials, as well as assistance in addressing any questions that may arise for the personnel involved in trial-related pharmacovigilance.
- Preparation of the Clinical Trial Safety Management Plan
We handle the creation of the clinical trial safety management plan (SMP), providing a systematic approach to clinical safety management that helps trial sponsors minimize safety risks for trial subjects and patients.
- Management of Serious Adverse Events
We supervise and manage serious adverse events (SAEs) in real-time that may occur during clinical trials, ensuring prompt detection, accurate evaluation, and reporting of serious and unexpected suspected adverse reactions to the relevant regulatory authorities.
- Development of Periodic Safety Reports
We prepare and manage periodic safety reports, such as Development Safety Update Reports (DSURs), which are required to meet national and international regulations, providing a comprehensive and updated view of the safety profile of the investigational medicinal product.
- Pharmacovigilance Audits
We conduct audits to ensure that pharmacovigilance processes in clinical trials are carried out efficiently, identifying areas for improvement and optimization.
- Training in Good Pharmacovigilance Practices for Clinical Trials
We provide ongoing training for research teams and sponsors on good practices in clinical trial pharmacovigilance, ensuring compliance with international standards and the well-being of patients. - Communication with Health Authorities and Use of Applications in Pharmacovigilance Activities
We offer support in setting up different applications necessary for communication with health authorities, as well as assistance with their use (EV, CTIS, etc.).