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Medical Writing

Specialist services to support your clinical trial

Specialist services in medical writing to support your clinical trial

Medical and regulatory documentation developed by experienced medical writing teams plays a pivotal role in the success of a clinical research project. Our professional service encompassing all regulatory requirements will be tailored to your needs.

Our medical writing team works closely with key operational departments including Biostatistics, Medical Affairs, Quality Assurance, Regulatory and Clinical Operations to access a fully integrated network of information.

Single point of contact

Each project is assigned a medical writer who is responsible for managing the writing process. A communication plan is drawn up to ensure you are aware of progress against timelines.

Our rigorous quality assurance process ensures all regulatory requirements are met and thatyou are provided with a professional, efficient service. We offer certified translations of all medical writing servicesfor our projects globally.

Full range of services

We offer a complete writing services panning from individual documents to extensive medical writing programs. Our medical writers have the therapeutic expertise and knowledge to deliver quality materials according to your specifications.

Regulatory publishing

  • Regulatory writing
  • Regulatory agency submissions

Clinical studies

  • Clinical study reports
  • Study protocols, amendments, and administrative changes

Educational

  • Publications, posters, and abstracts
  • Promotional and educational material

Other medical writing services

  • Investigator brochures
  • Patient narratives
  • Aggregate reports
  • Product labelling

With ICON’s quality management system, you can have confidence in your documents. We leverage technology and automation to increase efficiencies and build quality review and approval milestones in our processes.

ICON is technology agnostic, using a range of software for Medical Writing, including: EndnoteX8, Sage-based templates, PerfectIT, PleaseReview, Workshare, Veeva Vault, JMP Clinical, Protect ARARA.
 

ICON also provides a range of Medical Communications and Creative and Digital Services to support product brand success.

Scalable and fully customisable models

ICON is a trusted, market-leading partner to pharmaceutical, biotech and medical device organisations of all sizes. We are dedicated to helping sponsors implement, manage, and optimise high-performing functional teams. 

Our leadership approach provides bespoke oversight of medical writing activities, ensuring our clients’ projects run seamlessly. By driving team performance and guaranteeing consistent, successful delivery, we empower sponsors to achieve their trial goals with confidence and precision. 

We offer a wide range of customisable operating models to meet your needs, whether using ICON systems, sponsor systems, or a hybrid approach. Services can be delivered as consulting, standalone, FSP, blended or full service and across all therapeutic areas.

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Streamlining dossier preparation

Medical writing professionals play a pivotal role in preparing regulatory submission dossiers. Through years of experience, our experts have developed effective strategies to streamline the submission process and implement best practices that ensure high-quality, compliant documentation.

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