Clinical Documentation

Spectrum Regulatory Solutions' medical writing team is drawn from former industry professionals with proven track records in clear and effective communication and project management necessary for successful participation in multidisciplinary client teams.

Our service includes:

• Clinical Trial Authorisations (CTAs)
• Trial design and protocol development
• Assistance with multicentre/local ethics committee submissions (MREC/LREC)
• Drug Master Files (DMF)
• Advice on disclosure policy; establishment of registries and portals; writing summaries for online trial registries
• Standard Operating Procedure (SOP) preparation
• Writing of Clinical Study Reports (CSR) - Phase I, Phase II, Phase III and Phase IV
• Investigator brochures (IB) - de novo or annual updates
• Investigational Medicinal Product Dossiers (IMPD)

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