Pharmacovigilance
Pharmacovigilance Services
OrciTrials Pvt Ltd, a local Contract Research Organization (CRO), introduces its pharmacovigilance services, dedicated to safeguarding patient well-being by meticulously managing safety data related to pharmaceuticals, medical devices, and various products. Our pharmacovigilance department aligns its operations with the ICH guidelines and continually updates according to national and international regulations to ensure comprehensive safety monitoring and reporting. Furthermore, OrciTrials handles responsibilities associated with drug safety for both pre-marketing clinical trials and post-marketing pharmacovigilance.
Pharmacovigilance services offered by OrciTrials
1. Safety Information Management:
OrciTrials ensures prompt and rigorous management of safety information developed during the course of the trial in terms of AEs, SAEs or any trend that can lead to an outcome that has effect or impact on patient safety. Our mechanisms for safety information accrual, processing and evaluation pass through a discipline process driven approach which result in reliable and accurate data generation.
2. Pharmacovigilance Systems Master File (PSMF
We establish and maintain PSMFs, a regulatory requirement, to document the pharmacovigilance system, processes, and responsibilities, ensuring compliance with global regulations.
3. QPPV Services:
Our Qualified Person for Pharmacovigilance (QPPV) services include the appointment of experienced professionals who oversee safety and compliance, safeguarding product integrity.
4. Periodic Safety Reports
Orcitrials manages the generation and submission of periodic safety reports, maintaining compliance with regulatory obligations to report drug safety information at defined intervals.
5. Risk Management Plans:
We develop comprehensive risk management plans to mitigate and manage potential risks associated with pharmaceutical products, ensuring patient safety and regulatory compliance.
6. Individual Case Safety Reports Process:
Our team handles the collection, assessment, and reporting of individual case safety reports, ensuring adverse events are properly documented and reported to authorities.
7. Literature Searching
We conduct extensive literature searches to identify safety signals and emerging risks, aiding in the assessment of drug safety profiles.
8. Signal Detection & Analysis:
Orcitrials performs robust signal detection and analysis, identifying potential safety concerns and facilitating risk assessment and management.
9. Safety-Medical Writing:
Our expert medical writers produce clear and compliant safety documents, including PSURs, DSURs, and risk management plans, to support regulatory submissions.
10. Compliance & Quality Check:
We conduct thorough compliance and quality checks, ensuring that pharmacovigilance activities adhere to the highest industry standards and regulatory requirements.