Amarex's medical writers work closely with our Project Managers and the Lead CRA on the project to prepare documents to meet regulatory requirements on an on-going basis throughout the entire product process. Our medical writers have knowledge in ICH (International Conference of Harmonisation) guidelines and clinical study statistics for CSR (Clinical Study Report) content and format.

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We use a two step process for CSR writing:

1. ICH compliant CSR shell is produced before the trial is completed so the client can review, edit and approve the format in advance.

2. The first draft CSR is provided to the client within 2-3 weeks after database lock.

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Services include:

• ICH-GCP Compliant CSR

• Clinical & Pre-Clinical Study Protocols

• Informed Consent Forms

• Investigator Brochures

• ISS / ISE (Integrated Summaries of Safety and Efficacy)

• Manuscripts, Abstracts, Poster Presentations and Summaries

• GLP/GCP Audit Reports

• DSMB Reports