An integral phase of clinical research is providing clients with accurate high-end quality documents ready for global regulatory submissions. The team at MC are specialized in data conversion from complex crude paper formats to highly curated inter-intra linked ‘just a click away’ e-formats. Our core expertise includes preparation of pre-trial & post- trial documents and conversion of patient related data to organized electronic report formats matching scientific and regulatory standards.
Medical writing at MC includes:
Pre-trial and pre-database lock:
- Preparation of SOPs covering all phases of a trial conducted
- Clinical study protocols detailing the trial plan from execution to completion
- Informed consent forms detailing patient information/patient brochures
- Designing and management of case report forms to capture patient related details during the trial
Database lock at site (trial location)
Post-trial and post-database lock:
- Clinical study reports to accurately report the results of the trial
- Additional summary reports or synoptical reports as required by specific regulatory agencies
- Compilation of CSR and appendices in submission-ready formats (eCTD formats)
Independent documents:
- Investigator Brochure and Patient Narratives
- Safety Reconciliation
We also specialize in presenting specific patient related details for research purpose or assessments in future trial design based on pre-defined templates from the client. Eg: Demographic profiles, lab data pertaining to specific conditions, reconciliation of events occurred during trials etc.
Type of Clinical Study Reports:
- Complete CSR (pilot and pivotal) and appendices – Follows ‘E3 Structure and Content of Clinical Study Reports’ and is used to support approval from regulatory agencies such as FDA or EMA.
- Abbreviated CSR – Condensed version of the full CSR, that are not intended to contribute to the evaluation of product effectiveness, provides sufficient information about the trial conducted and elaborate only the significant safety procedures
- Supplemental CSR – Addendums or follow up details to the full CSR already submitted to the regulatory authority
- Synopsis report – Generally includes only examined details to assess the safety of the product for the proposed indication
- Terminated and Interim reports – Short version of reports providing details of termination and extent of trial conduct.
- Summary tables – Supportive tabular data based on regulatory/client request.
