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.
We establish and maintain PSMFs, a regulatory requirement, to document the pharmacovigilance system, processes, and responsibilities, ensuring compliance with global regulations.
Our Qualified Person for Pharmacovigilance (QPPV) services include the appointment of experienced professionals who oversee safety and compliance, safeguarding product integrity.
Orcitrials manages the generation and submission of periodic safety reports, maintaining compliance with regulatory obligations to report drug safety information at defined intervals.
We develop comprehensive risk management plans to mitigate and manage potential risks associated with pharmaceutical products, ensuring patient safety and regulatory compliance.
Our team handles the collection, assessment, and reporting of individual case safety reports, ensuring adverse events are properly documented and reported to authorities.
We conduct extensive literature searches to identify safety signals and emerging risks, aiding in the assessment of drug safety profiles.
Orcitrials performs robust signal detection and analysis, identifying potential safety concerns and facilitating risk assessment and management.
Our expert medical writers produce clear and compliant safety documents, including PSURs, DSURs, and risk management plans, to support regulatory submissions.
We conduct thorough compliance and quality checks, ensuring that pharmacovigilance activities adhere to the highest industry standards and regulatory requirements.
