Safety Writing for Clinical Trials
From DSURs to RMPs — Structured, Accurate, Submission-Ready
Expertly crafted safety documents that stand up to regulatory scrutiny.
From Development Safety Update Reports (DSURs) through Risk Management Plans (RMPs) and Periodic Benefit-Risk Evaluation Reports (PBRERs), Veristat’s Safety Writing and Aggregate Reporting services enable sponsors to deliver scientifically rigorous, high-quality safety documents that meet global regulatory standards. These multidisciplinary deliverables bring together clinical, nonclinical, safety and regulatory data into a unified profile, carefully crafted for submission, consistency, and clarity across every stage of a drug’s lifecycle.
Clear, consistent aggregate safety reporting
Transforming complex safety data into compliant reports across the product lifecycle
Integrated Expertise
Veristat offers a unified team of pharmacovigilance experts, reducing hand-offs and ensuring seamless project execution.
Global Compliance Assurance
Our in-depth regulatory knowledge ensures adherence to guidelines across major global agencies.
Customized Solutions
Flexible processes tailored to meet changing regulatory requirements and project timelines.
Lifecycle Safety Reporting
Our safety writing services support every stage of the drug lifecycle to ensure compliance and transparency.
Veristat’s Expertise And Unique Approach
Veristat: Innovating Pharmacovigilance with Expertise and Technology
Comprehensive Safety Document Support
Veristat authors all safety-related documents, including DSURs, RMPs, PBRERs, and more, ensuring compliance throughout the drug lifecycle.
Proactive Risk Management
Anticipate and address challenges before they impact timelines with proactive project management and regulatory insights.
Proven Success with Global Agencies
With a track record of excellence, Veristat collaborates with global regulatory bodies to meet stringent safety standards across every phase of product development.
Collaborative, Cross-Functional Expertise
Veristat integrates safety writing with clinical, regulatory, and pharmacovigilance insights to deliver cohesive, submission-ready reports that reflect the full picture of product safety.
Veristat's Offerings
- Development safety update report (DSUR). Required annually throughout clinical development of a drug. Can also be required in the post-market setting if clinical trials are still ongoing e.g., in other indications.
- Risk management plan (RMP). Required for marketing authorization applications to the EU. While most regions accept the EU format, regional variations often necessitate tailored versions. We work from your Core RMP to ensure consistency with your strategic position.
- Periodic safety update report (PSUR)/Periodic benefit-risk evaluation report (PBRER). EU regulations require submission every six months for the first two years, then annually, unless specified differently in the EURD list. The US FDA accepts this format with an approved waiver.
- Periodic Adverse Drug Experience Report (PADER). For US markets, quarterly reports are required for three years, followed by annual submissions. This format is typically used for drugs approved exclusively in the United States.
- Safety Assessment Report. From Health Authority query responses to signal evaluations and safety topic reviews, these ad hoc reports address emerging safety considerations as they arise.
- Addendum to the Clinical Overview (ACO). EU market authorization renewal requires ACO submission at least nine months before license expiration, ensuring continuity of your market presence.
Meet Our Experts
Every one of these services is backed by hands-on experience in the areas that matter most: adaptive designs, rare disease and small populations, complex biologics data, and independent safety oversight, delivered at the speed your program needs.
Mary Pilkington, PhD
Associate Director | Service Line Head (Safety/PV)
Regulatory Services & Medical Affairs
Associate Director and Safety/PV Service Line Head, bringing two decades of regulatory writing excellence to every client.
WHY US
Why Choose Veristat for Pharmacovigilance Consultancy?
Veristat brings together unparalleled expertise, innovative technology, and a proven track record to deliver comprehensive pharmacovigilance consultancy services. We prioritize patient safety and regulatory compliance through tailored solutions that adapt to your specific needs.
PROOF POINTS
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223+ Annual Safety Reports/DSURs Authored
Over the past five years, Veristat has successfully authored more than 223 Development Safety Update Reports (DSURs) and Annual Safety Reports.
PROOF & RESOURCES
Real Programs, Real Outcomes
Categorizing & Managing Risks In Aggregate Safety Reports
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Delivering High-Quality Responses
To EMA Safety Queries
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Ask the Experts: All About Safety Documents
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Turn safety data into the full picture.
Safety data rarely tells its story in one place. Veristat brings clinical, nonclinical, safety, and regulatory evidence together to reveal the evolving benefit-risk profile of your product and translate it into rigorous, submission-ready reporting that keeps regulators informed and your safety strategy grounded in the evidence.
Frequently Asked Questions
Aggregate reports bring together data from nonclinical, clinical, safety, regulatory, and CMC disciplines. This integrated approach provides a complete view of product safety and encourages collaboration across Veristat’s broader writing and regulatory service lines.