Drug Safety and Pharmacovigilance
Where patient safety is concerned, data quality matters most
With ever evolving regulations, protecting patient safety is becoming more challenging whilst still demanding unwavering excellence. Success rests on proactive engagement with industry changes – and an approach that places quality and innovation first – whether your products are in development or on the market.
We are recognized by ISG as an industry leader in pharmacovigilance and regulatory affairs
Cases processed annually
On-time case submissions to clients/ partners in 2020
On-time case submissions to regulatory authorities in 2020
Complete portfolio of high-quality global safety solutions across the product lifecycle
Case processing
We provide 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.
Our 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
Our GVP-compliant signal management services include detection, validation, assessment and tracking.
Signal detection 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
We have 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.
QPPV & PSMF
Our >15 years of QPPV experience includes the set up and maintenance of complex global pharmacovigilance 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
Our 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.
We have 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.
Pharmacovigilance consulting
Whether you need to establish a new pharmacovigilance system, make changes to your existing system or need to meet regulations in an unfamiliar geographical region, our pharmacovigilance experts are here to advise and recommend a customized safety solution.
Focused on maintaining exceptional staff
As technology advances across the pharmacovigilance (PV) landscape, we’re thoughtfully evolving our workforce to be ready for what’s to come. Our priority is to ensure business continuity to adhere to regulations because patient safety matters.
- Committed to hiring talent and developing critical pharmacovigilance skills as the market changes
- Industry benchmarking to ensure best practices are always in place
- Dedicated to our employees’ career development and growth, which drives high retention and sets us apart from other organizations
Strategic locations in 28+ countries
Years average tenure:
Senior & principal level staff
Years average tenure:
Manager level and above staff
Pharmacovigilance experts
Pharmacovigilance services are also offered as an FSP model
Managing safety more efficiently with business process management solutions
Our pharmacovigilance team has implemented an internally developed tool called the Safety Tracking System (STS), used to monitor safety processes and workload coordination, providing high-quality and compliant safety deliverables.
Leading-edge innovations – more than systems
Technology
- Centralized RA & EC Submission Tracking (CREST) – Regulatory agency and ethics committee submission management tool.
- Safety Databases – we have offered hosting in Aris Global’s systems since 2012. We also have extensive experience in working in client systems.
Automation
- We also look to add technology enablers to augment the best-in-class solutions in our industry such as Robotic Process Automation.
- Monitoring trends with a view to embracing AI technologies when they prove to be stable and effective for pharmacovigilance use.
Process improvement
- Our global team of experts share a strong culture of process improvement based on Lean Six Sigma. We’re continually working to increase our efficiency.
- We have instituted a stage-gate review process managed by senior leadership which includes clearly defined stages: planning, analysis, design, implementation, and monitoring.
- Our deep industry experience alongside our proven success in process automation allows us to assess the marketplace to vet viable solutions using sound processes/technique.
The flexible pharmacovigilance partner for marketed product safety
Safeguard your regulatory compliance and manage risk over the lifetime of your product. We are uniquely positioned to coordinate end-to-end pharmacovigilance activities across the globe. Our teams provide oversight of daily pharmacovigilance operations, including interactions with medical affairs, regulatory affairs, clinical development and quality assurance.
