Medical Writing

Communication through precision and clarity

At the heart of a successful trial is great communication. Proper clinical documentation can streamline study activities, clear communication channels between sponsor, CRO and regulatory groups and ease the process of regulatory submission. Benefit from ARI’s experience in understanding regulatory requirements and medical writing experience. ARI provides:

• Writing of clinical study protocols and clinical research reports, ensuring documentation are in compliance with ICH requirements
• Collaborating with regulatory affairs, biostatistics and PK groups, to review and provide feedback on study protocols, case report forms, statistical analysis plans and informed consent forms
• Undertake review process to ensure that all documents are in harmony and compliance with regulatory requirements, GCP guidelines and SOPs.
• Writing of patient narratives for clinical research reports.

Experiencing writer’s block with your study? Contact ARI today.

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