Pharmacovigilance that grows with your program
Safety responsibilities grow quickly as studies expand into more countries, each with its own and evolving reporting requirements.
We support your pharmacovigilance operations across clinical development and post-marketing. Our medical, regulatory and drug safety experts help you manage safety data, monitor risks, meet reporting timelines and maintain oversight of your product’s safety profile.
Dedicated teams retain knowledge of your compounds, previous assessments and reporting decisions as your program evolves.
Consistent regulatory execution
Use SGS as your full pharmacovigilance partner, for specific activities or as backup support your for your local affiliate safety teams .
Experienced safety specialists
Our multidisciplinary team includes physicians, pharmacists, scientists and regulatory experts with experience from first-in-human studies to post-marketing.
Continuity across development
Established processes support accurate case handling, independent quality control and timely reporting across countries and regions.
When you need to be sure
Build the right pharmacovigilance model
Whether you need an end-to-end partner, additional safety expertise or support for a specific reporting or migration challenge, we help you define an approach that fits your program.
Carl Beyers
Business Development Manager, SGS
Mid-sized pharmaceutical company in an 18-year partnership with SGS for a single compound
Client
SGS provided the medical expertise, operational continuity and regulatory support we needed as our safety responsibilities expanded across studies and regions.
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How we can support you
Safety case management
We manage ICSR intake, processing, coding, narrative writing, follow-up, medical review, quality control and regulatory submission.
Medical review and signal management
Our safety physicians assess cases, review related events and support signal detection, surveillance and ongoing evaluation of the safety profile.
Safety writing and aggregate reporting
We prepare DSURs, PSURs, PBRERs, case narratives, clinical safety summaries, benefit-risk assessments and periodic listings.
Regulatory submissions and intelligence
We support reporting requirements across regions.
Safety database services
We set up and manage Oracle Argus or work within your existing system, with client access to cases, reports and safety data.
Safety data migration
We plan, execute quality-check and document data migrations for vendor changes, database consolidation, licensing and asset transfers.
Maintain control as medical safety requirements grow
Pharmacovigilance involves more than processing adverse event reports. Sponsors need consistent medical assessment, timely regulatory reporting, reliable safety surveillance and access to complete safety data.
We can manage pharmacovigilance independently of the CROs running your clinical studies. This gives you one accountable safety partner across studies, development phases and regions. Support can start with your first-in-human study or through a structured transition from an existing provider.
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About SGS Clinical Research
We're a mid-sized, full-service CRO specialized in early-phase development and biometrics. We offer drug development consultancy, project management, monitoring, data management, statistics, medical writing, safety and regulatory services. We have our own clinical pharmacology unit in Belgium featuring a viral challenge facility and have access to patients through our site network with 400+ sites. Our key therapeutic areas include infectious diseases, vaccines, respiratory, dermatology and oncology.
180+
pharmacovigilance projects delivered in the last 5 years
45+
safety specialists
80%
of our projects are delivered through a functional service model
20+
safety database migrations completed, some with 10,000+ cases
One safety database across your studies
When each study CRO manages safety separately, cases, workflows and reporting processes become fragmented. This makes reconciliation, aggregate reporting and sponsor oversight more complex.
We recommend consolidating safety data for a compound in one safety database. This gives you a consistent safety history across studies, faster onboarding of new trials, simpler reporting and easier data transfer during licensing, acquisition or a change of provider.
Flexible delivery
Operational excellence
Proven, consistent delivery with strong KPI and KQI performance, demonstrating quality, compliance and on-time delivery.