Pharmacovigilance Outsourcing

Case Management

PharmXL provides 24/7/365 adverse event management and reporting services to comply with regulatory timeline. Adverse event case processing from different sources i.e. clinical trial, literature, spontaneous, marketing program, call centre, health authority and various licensee parties in the pharmacovigilance database. Further, manage the reportability based on the seriousness and expectedness of adverse events.

Literature Searches

PharmXL, offers comprehensive worldwide adverse event literature screening services for all types of products by using appropriate terms. It includes:

Periodically monitored the worldwide publications for relevant product Screening of literatures to identify the potential ICSRs via validated database such as Pubmed and Embase

Monitor the articles in targeted local journals in each territory where product is marketed Triage analysis and relevant processing for expedited or periodic reporting for literature ICSRs Screening the literature to identify the potential or new safety signals for inclusion in safety reports

Screening the literature for targeted events for benefit risk analysis

If require procure the full length articles for assessment of ICSRs

Signal Management

Our team is expertise to assess safety data to identify the new safety signals and develop robust risk management plans (RMPs) to healthcare products. Our signal detection program consists following approach.

Risk Management

PharmXL provides strategic advice and analysis on risk managements begin with assessment and identification of potential risks associated with a product. On the basis of identified risk we develop risk minimization plan in collaboration with clients. Our team proactively review and helps the clients to monitor and minimise the risk profile of product to deliver the greater patient safety. We develops risk evaluation and mitigation strategies (REMS) and REMS update reports for USA and compiles, writes and updates risk management plans (RMPs) for Europe/Asia.

Aggregate Report Writing

PharmXL reports writing experts ensures that periodic reports, risk assessment documents and safety update reports are prepared in the proper format with appropriate content and submitted to the relevant regulatory authorities as per timelines via electronic or printed version. Our dedicated healthcare team committed to generate quality and consistent reports in order to provide greater patient safety. We prepared following reports and submitted to relevant regulators :-

Global periodic safety reporting (PADER, PSUR/PBRER)

 • Generation of tables & listings from safety database

 • Analyze line listings and prepare relevant tables

 • Analyze previous aggregate reports for the product

 • Compose case summaries and analysis

 • Medical review of each report

 • Draft report for client review and approval

 • Tracking of reporting periods and submission dates

Clinical periodic reports – IND/NDA annual reports and developmental safety update reports (DSURs).

 • Addendum reports

 • Bridge reports

 • Annual safety reports

 • Ad hoc aggregate safety data reports and analysis

 • Report submissions to appropriate regulatory authorities

Qualified Person Responsible for PV