Drug Safety, Pharmacovigilance & Risk Management

Our senior safety physicians and scientists are experts in designing and leading cutting-edge risk management and pharmacovigilance (PV) programmes. Their unparalleled expertise equips us with a comprehensive, global perspective, enabling us to not only secure regulatory approvals and achieve label extensions but also to excel in vigilant safety monitoring.

Strategic Expertise

Strategic Expertise

Operational Excellence

Our drug safety and PV team offers comprehensive support throughout the entire drug lifecycle.

From early clinical development to post-licensing PV, our tranScrip experts ensure your projects are in expert hands. We provide services including PV inspection readiness and training, post-approval safety study planning, and end-to-end safety signal management. We have access to a regulatory compliant in-house safety database and support Data and Safety Monitoring Board (DSMB) activities. Additionally, we offer Qualified Person for Pharmacovigilance (EU/UK) support.

Explore our comprehensive services

Maximise the value of your products with our bespoke solutions.

Pre-Approval Drug Safety Management

Navigating the complexities of drug safety before market approval requires meticulous planning and execution. Our team excels in:

  • Clinical Trial Safety Monitoring: Real-time surveillance and management of adverse events during clinical trials.
  • Pre-Market Risk Assessment: Comprehensive evaluations of potential risks associated with drug candidates.
  • Safety Data Management: Detailed tracking and analysis of safety data to ensure robust pre-approval safety profiles.

Signal Detection and Management

Effective signal detection is crucial for identifying potential safety concerns early. We provide:

  • Signal Assessment and Prioritisation: Evaluating the clinical significance of detected signals to inform risk management strategies.
  • Ongoing Monitoring: Continuous review of safety data to identify and respond to emerging safety signals.

Data and Safety Management Board Activities

Our approach to data and safety management includes:

  • Board Meeting Facilitation: Coordination and preparation for Data Safety Monitoring Board (DSMB) and Safety Management Board meetings.
  • Data Review and Analysis: In-depth evaluation of clinical trial data to provide actionable insights.
  • Recommendations and Reporting: Providing recommendations for study modifications or safety interventions based on board evaluations.

Safety Report Preparation

Timely and accurate safety reporting is essential for regulatory compliance. We offer expert preparation of:

  • Development Safety Update Reports (DSURs): Comprehensive reports detailing the safety profile of investigational products during development.
  • Periodic Safety Update Reports (PSURs)/ Periodic Benefit-Risk Evaluation Report (PBRER): Regular updates on the safety of approved drugs, summarising the benefit-risk balance and any new findings.
  • Risk Management Plans (RMPs): Strategic plans outlining risk minimisation and management strategies to ensure drug safety.
Perfectly positioned

Perfectly positioned

for a unique partnership

Navigating the intricate landscape of global pharmacovigilance regulations demands more than just expertise, it requires seasoned professionals who can guide you through every twist and turn. Our drug safety specialists bring hands-on experience and an agile approach, seamlessly integrating with your team to amplify your capabilities. We offer not just support, but a dynamic partnership that evolves with your needs, ensuring you stay ahead in a constantly shifting regulatory environment.

Case Study

Navigating the Development Path for Novel Immunological Biological Products

Read more

Brochure

Overview Flyer

Read more

“I have worked with tranScrip on several occasions, in my previous capacity as Head of Development and Chief Medical Officer at Polyphor AG and in my previous role as Chief Medical Officer at Polyneuron AG.

Services tranScrip have provided in the therapeutic areas of oncology, infectious diseases, neurology and rare diseases have ranged from protocol writing, manuscript writing, drug safety, clinical pharmacology and microbiology. To simply state that they have delivered consistently and to a high standard of quality would badly understate the impact they have had on the performance and ability of the companies to execute and deliver on key investor and regulatory milestones. Strategic oncology input enabled us to design a winning oncology strategy, deliver a publication in a Key Journal in time for IPO and write the protocol for the pivotal study. tranScrip’s staff were able to integrate seamlessly and work (remotely) as a full value adding part of the team. This delivering as part of the team was also seen in the drug safety and clinical pharmacology support where tranScrip employees integrate to the team and add value from their general drug development experience, as well as their specific area of key focus, both of which are appreciated.

As well as proactive ongoing support, tranScrip have also demonstrated their effectiveness on “emergency interventions”, able to pull a team together at short notice for a deep dive into a problem after regulatory advice has been received. The quality of the technical input and contribution to problem solving is impressive, as well as the higher level drug development and safety expertise to participate in the development of overarching and comprehensive effective solutions.”

Debra Barker

Chief Medical Officer

Destiny Pharma

Contact Us

Our experienced physicians and scientists, together with our regulatory, clinical and commercial experts can support you to maximise the value of your products. Whatever your project requires, we have the expertise to meet your needs.

Get in touch