A whole range of regulatory and non-regulatory documents is required during clinical trials. The success of drug approval hinges on the quality of these documents – and this is where the Medical Writing Team of CRS comes in.
The Medical Writing Team offers expert services ranging from preparing individual documents to producing all the documents needed for the draw up, coordination and documentation of clinical trials in a scientifically accurate way. Thanks to their extensive experience the professionals in the Medical Writing Team understand how to meet challenging timelines and to crystallise the essential data. They are able to integrate clinical and operational data into concisely written, well structured documents complying with current regulations and guidelines. The bottom line is that CRS makes sponsors' clinical trial documentation more efficient, saving both time and money.
- CRS’s Medical Writing Team specialises in...
- Writing, preparing, and compiling clinical study protocols and integrated clinical study reports complying with GCP and ICH-E3
- Writing, preparing, and compiling clinical and non-clinical sections of the Investigational Medicinal Product Dossier (IMPD) and the Common Technical Document (CTD) and the investigator’s brochures (IB) in close cooperation with scientific and medical experts
- Preparing and submitting manuscripts for publication in close cooperation with scientific and medical experts
- Giving support in the drafting and editing of lectures, presentations, and posters
- Providing expert assistance in literature research
- Range of services
- Clinical study protocols
- Integrated clinical study reports pursuant to ICH E3 and complying with electronic Common Technical Document (eCTD) standards
- Clinical and non-clinical sections of the Investigational Medicinal Product Dossier (IMPD)
- Clinical and non-clinical summaries and overviews of Common Technical Documents (CTD)
- Development and therapeutic areas:
- Phase I
- Clinical pharmacology studies – pharmacokinetics and pharmacodynamics
- Biologics and biosimilars