Overview - Individual Case Safety Report (ICSR) Processing Serviecs
Patient safety is of utmost importance and the root of all decisions along the entire drug development pipeline. Systems must be established to ensure that safety related data is collected and managed appropriately to mitigate potential or confirmed risks relating to a pharmaceutical product. ICSR case processing and submission are integral components of pharmacovigilance as they provide critical safety data in the form of adverse reactions of serious & non serious nature with cause & effect analysis. The ADRs are received from various sources that include, but are not limited to, Health Care Providers (HCPs), patients, consumers (spontaneous reports), scientific literature, clinical studies, epidemiological studies, and any post-approval clinical/safety studies that have been conducted.
DDReg understands the importance of adhering to global and national ICSR Case Processing requirements. Our ICSR Pharmacovigilance Services comprehensively covers all stages of case reporting, be it case receipt, duplicate check, triage, data entry, quality check, medical review, case publishing and/or final submission to competent authorities.Our highly experienced team processes the ICSRs received from various sources and provides our customers with end-to-end assistance in handling diverse reports.
DDReg’s ICSR Pharmacovigilance Processing & Submission capabilities include:
- Receiving Adverse drug events, Medical Information queries & Product Quality Complaints.
- Triage of initial and follow-up ICSRs, SUSARs,
- Case Processing through E2B(R3) compliant databases and other relevant databases integrated with Drug dictionary (WHO DD) and MedDRA
- Quality Check, Medical reviews
- Submission of cases as per agency timelines
- Maintaining ICSR monitoring & tracking sheets
- Reconciliation process with customers
Basics of ICSR Pharmacovigilance
ICSRs form the cornerstone of post-marketing drug safety surveillance and basis of pharmacovigilance. Different competent authorities around the world have different requirements for ICSRs, especially with respect to their reporting. They contain important information on patients, the adverse events they have experienced, and information regarding the suspected drug. ICSR Pharmacovigilance reports provide a detailed description of the adverse events such as its nature, severity, onset, and outcome which is critical to assess the impact of a drug on patient safety. It also includes information on the concomitant medication and medical history of the patient which helps in identifying if there is a causality between the adverse event and the suspected drug.
It is important for pharmaceutical companies to submit the ICSRs associated with their products to competent authorities within the required timeline. Most authorities have established electronic systems that allow ICSR processing and submission, which streamlines the process and accelerates ICSR submission. This is important to ensure that safety concerns regarding drugs and allied pharmaceutical products are addressed efficiently and promptly. ICSRs that are comprehensive and accurate help support patient safety and competent authorities in making decisions regarding the drug. This contributes towards the overall risk-benefit assessment of drugs that are on the market and aim to safe guard public health.