Meticulous patient safety narratives, periodic aggregate safety reports (DSURs, PSURs, PBRERs), and 100% data reconciliation designed to protect patient welfare and maintain global regulatory compliance.
Regulatory health authorities review clinical safety data with forensic scrutiny. A single discrepancy between an adverse event listing and an individual patient narrative, or an inconsistently coded MedDRA term, can trigger extensive regulatory queries, delay marketing approval, or compromise audit readiness.
Kensai Health provides comprehensive pharmacovigilance writing services grounded in hands-on clinical and safety systems experience. Having actively managed medical inquiries and participated in safety platform implementations (such as Argus Safety), our team delivers safety documentation that is medically rigorous, chronologically coherent, and 100% data-verified.
Every SAE narrative is cross-reconciled against patient profiles, MedDRA dictionaries, CIOMS I / MedWatch forms, and the EDC clinical database before delivery.
We author individual patient narratives for Section 14.3.3 and Appendix 16.3 of the ICH E3 CSR. We reconstruct clear, clinical chronologies detailing patient medical history, concomitant medications, event onset, hospital course, de-challenge/re-challenge, and causality assessment.
The annual cornerstone of ongoing investigational compliance under ICH E2F. We synthesize worldwide clinical safety data across all ongoing trials for an investigational drug, ensuring harmonization across FDA IND and European CTA reporting deadlines.
Authoring Periodic Safety Update Reports (PSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs) according to ICH E2C(R2) guidelines. We integrate worldwide spontaneous post-marketing safety data, literature reviews, and clinical trial readouts.
Safety reporting failures often stem from reconciliation errors between the clinical trial EDC database and the pharmacovigilance safety database. We perform systematic reconciliation to verify SAE counts, onset dates, severity, and causality across both datasets.
Developing comprehensive EU Risk Management Plans (EU-RMP) and US Risk Evaluation and Mitigation Strategies (REMS). We articulate identified risks, potential risks, and missing information along with targeted pharmacovigilance activities.
Collaborating with Sponsor Medical Monitors and Drug Safety Officers during real-time data monitoring committee (DMC) or data safety monitoring board (DSMB) reviews, drafting clear responses to health authority safety inquiries.
A multi-tiered safety review process that guarantees audit readiness.
We establish standard narrative templates aligned with the protocol, defining mandatory chronological fields, lab parameters, and concomitant therapy details.
Experienced writers construct coherent narratives that contextualize the adverse event within the patient’s clinical journey, eliminating ambiguous medical timelines.
An independent quality auditor checks every date, dosage, lab result, and MedDRA term against raw CIOMS forms and patient listings before final delivery.
