To be granted regulatory and ethics committee approvals to perform a clinical trial, the Clinical Trial Dossier (CTD) and all its component documents must not only adhere to applicable guidelines and legislation but must also be written to the best possible quality standards. Medical writing skills are central to this.
At SMS-oncology we use a multidisciplinary team with proven medical writing skills to ensure the content, accuracy and presentation of any document meet the highest quality standards. Our medical writers carry this out with input from consultancy, medical affairs and clinical operations teams.
Tasks involve anything from drafting, reviewing, updating to full writing of regulatory documents, supporting our sponsors with high-quality documents that meet all GCP and industry standards, including:
- Investigational Medicinal Product Dossier (IMPD)
- Investigational New Drug (IND) file
- Investigator Brochure (IB)
- Clinical study synopsis
- Clinical study protocol
- Study-, country- & site- specific master informed consent forms (ICFs)
- ICH E3 compliant clinical study report (CSR)
In addition, we offer a free and confidential review of the of your planned early phase oncology trial (draft) protocol, thereby providing you with comprehensive, strategic and clinical recommendations. For more information, see expert protocol advice (free).