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Product Lifecycle

Complete Portfolio of High-quality Global Safety Solutions

Case Processing

PPD provides an extensive suite of case processing options with or without medical review, for both clinical trial and post-marketing cases.

Our case processing teams process over 500,000 initial and follow-up versions each year with a >99.9% on-time completion compliance rate.


Safety Reporting

Our global clinical trial and post-marketing reporting capabilities are backed by robust regulatory intelligence, for both individual case and aggregate report submissions to regulatory authorities, ethics committees/institutional review boards and investigators.

PPD’s central safety reporting team (CSRT) staff are located in key global hubs, supplemented by local in-country staff where required, and submit to over 3 million recipients annually with a >99% compliance rate.


Literature Surveillance

Our dedicated literature surveillance team performs end-to-end literature safety surveillance activities that support both clinical trial and post-marketing activities, including ICSR detection and review for signal detection purposes.


Signal Management

PPD’s GVP-compliant signal management services include detection, validation, assessment and tracking.

Signal detection at PPD is performed by a dedicated team with more than 25 years of collective experience. Supported by M-SERM physicians, our safety scientists routinely extract and analyze safety data, and conclude on the safety profiles of the products they are responsible for.


Safety Writing

PPD has a full range of aggregate safety report and risk management plan writing capabilities to meet both your clinical trial and post-marketing needs (e.g. DSUR, PBRER, PADER, EU-RMP).

By deploying a specialized team of safety writers who work across a broad spectrum of document types and therapeutic areas, we ensure that only employees with the most appropriate skillset and experience support this critical task.

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QPPV & PSMF

PPD’s >15 years of QPPV experience includes the set up and maintenance of complex global PV systems and participation in non-’routine’ pharmacovigilance activities.

Our QPPVs can provide general pharmacovigilance consultancy in addition to the QPPV ‘oversight’ role, and can effectively advise on additional pharmacovigilance/risk minimization activities over the life cycle of your product(s).

Beyond the EU and UK QPPV roles, PPD also has extensive experience in PSMF and SDEA authoring/management.


MEDICAL SAFETY EVALUATION & RISK MITIGATION (M-SERM) PHYSICIANS

PPD’s M‐SERM team of 40+ physicians provide safety and medical expertise across the product lifecycle.

Strategically distributed in 11 countries and three continents (Asia, Europe, and the Americas) to provide services around the clock, supporting clinical trials as well as post-marketing safety.

In addition to reviewing individual case safety reports (ICSR) for serious and non-serious events, they collaborate on literature review and the production of aggregate safety reports, provide support for safety signal detection and safety risk management plans, and provide consultation on clinical trial safety issues.


CLINICAL TRIAL SAFETY COMMITTEE MANAGEMENT

We have full capabilities to fulfill your adjudication/clinical endpoint committee (CEC) and data safety monitoring board (DSMB) requirements.

PPD has dedicated staff for management of CEC and DSMB coordination activities. Our specialty committee staff have 15+ years of experience in both commercial and government sponsored global studies.


PV Consulting

Whether you need to establish a new PV system, make changes to your existing system or need to meet regulations in an unfamiliar geographical region, PPD’s PV experts are here to advise and recommend a customized safety solution.