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Safety writing solutions

In today’s highly regulated healthcare and pharmaceutical industries, the importance of comprehensive and accurate safety writing solutions cannot be overstated. 

Regulatory authorities worldwide demand rigorous reporting to ensure that safety risks associated with drugs and medical products are effectively monitored and managed.

ICON is a trusted partner in delivering high-quality, compliant safety documentation. With a team of skilled safety medical writers and scientists, we offer flexible, scalable solutions for clients of all sizes, from small biotechs to large pharma, ensuring cost-effective, timely, and globally compliant reporting.

We have extensive experience in the generation of aggregate safety reports and continuously monitor regulatory requirements from health authorities worldwide. We offer tailored support for smaller clients while efficiently managing high-volume report delivery and global scheduling for larger organisations. To ensure cost-effectiveness, we leverage the expertise of our Safety Medical Writers and Safety Scientists from lower-cost regions, delivering high-quality results while optimising resources.

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Aggregate safety report generation

ICON has extensive experience generating aggregate safety reports (ASRs) for both developmental compounds and marketed products including:

  • Development Safety Update Report (DSUR)
  • IND annual report
  • Local country-specific clinical safety reports (such as, Final Safety Report--Mexico)
  • NDA Periodic Adverse Drug Experience Report (PADER)
  • Periodic Safety Update Report (PSUR)/Periodic Benefit-Risk Evaluation Report (PBRER)
  • Addendum to Clinical Overview (ACO)
safety writing

Wherever possible, we look to remove the complexity from ASR generation. With established procedures, a global team of highly experienced safety medical writers, and the support of a dedicated safety regulatory intelligence team, we deliver fully compliant aggregate safety reports, efficiently and cost effectively, and tailored to evolving global requirements

We offer robust, proven, and inspection-ready procedures and systems, while also being able to operate within client-established frameworks. This allows us to deliver flexible, custom-fit solutions tailored to each client’s specific needs and existing capabilities.

We also offer a modular approach to our end-to-end suite of ASR services, allowing clients to select the specific level of support needed, from management of worldwide reporting schedules through to authoring, review, publishing and/or submission of individual reports. 

Risk management planning

Our Safety Medical Writers provide expert support in the development of Risk Management Plans, as well as related educational materials and targeted follow-up questionnaires. Learn more. 

Literature search & evaluation

At ICON, we apply a structured and scientific approach to literature search, ensuring comprehensive search coverage, expert analysis, and the delivery of robust, well-authored summaries by our experienced Safety Medical Writers.

Our services include:

  • Epidemiology reviews to support clinical trial planning and risk management for marketed products
  • Safety signal detection and risk assessment
  • Labelling changes and regulatory strategy for indication expansions, prescription-to-OTC switches, and updates to contraindications, precautions, warnings, or new dosage forms/routes of administration

We deliver fully referenced, structured summaries that support regulatory discussions and help facilitate efficient submission processes with regulatory authorities.

Document quality review

Our expert Safety Medical Writers enhance the quality and compliance of safety and regulatory documents through specialised review and consultation services. We ensure accuracy, consistency, and alignment with applicable guidelines, delivering clear, precise, and submission-ready documentation. 

Our services include:

  • Editorial quality checks
  • Content verification against source materials
  • Compliance reviews with regulatory standards
  • Manual assessments of AI-generated content

Partner with ICON to simplify your safety reporting and ensure global compliance. 

Contact us to find out more about our tailored safety writing solutions.

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