Management of Serious Adverse Events (SAE) & Suspected Unexpected Serious Adverse Reactions (SUSAR)
Case Management Services
Our Case Management Process
Regarding case management, We provide a comprehensive and meticulous approach to handling Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs). Our streamlined process includes the following steps:
- Get Report: Prompt acquisition of comprehensive case details for a thorough evaluation.
- Evaluation: Assessing whether the reported case is reportable and determining its severity.
- Reporting: Processing the report according to local regulations if it’s reportable; leveraging non-reportable cases to enhance the product.
- Submission to the Health Authority: Timely and accurate submission of reports to the relevant Health Authority.
Our follow-up strategy follows good pharmacovigilance practices. We conduct two follow-ups for serious cases within specific timeframes: one within 15 days and the second within one month. Non-serious cases involve at least one follow-up within 30 days.
Streamlined Individual Case Safety Report (ICSR) Management
Jeyflex ensures end-to-end ICSR Management solutions by offering a comprehensive suite of services, including collection, triage, data entry, quality review, and regulatory submission of ICSRs to the Health Authorities. Periodic reconciliation of safety cases is conducted following Pharmacovigilance Agreements and contracts.
Types of Pharmacovigilance Data
Our case management services handle various types of PV data, including:
- Adverse Drug Reaction
- Off-label Use
- Occupational Exposure
- Medication Error
- Falsified Medicinal Product
Case Validation Process
Ensuring the necessary criteria are met for reportable Individual Case Safety Reports (ICSRs), our comprehensive validation process checks for the presence of the following key information:
- Identifiable patient details, including age, gender, and initials.
- Identifiable reporter details, including name, address, phone, and email.
- Comprehensive information on the suspect product, such as name, indication, dose, route of administration, and start and stop dates.
- Detailed descriptions of the adverse event, including timing, nature, and outcome.
Our efficient case management services prioritize accuracy, compliance, and timely reporting, ensuring the highest standards of pharmacovigilance and patient safety.
Our solutions are tailored to meet your unique needs and requirements, whether you’re a small startup or a large multinational corporation. We offer a range of services, including, consulting, training, and auditing, to help you ensure that you are complying with relevant regulations and laws, and to minimize the risk of non-compliance.