Medical Writing
Medical writing is an integral part of all phase I-IV clinical research. The progression of compound in the development process hinges on the data obtained from clinical trials and its accurate presentation and interpretation.
The manner in which a protocol is put together is equally important to the data produced and how it is presented, as it dictates the way a study will be conducted. Cmed CS’s Medical Writing team has considerable experience in producing Clinical Study Protocols and Study Reports according to ICH guidelines as well as specific region/country requirements including Asia Pacific. Each protocol is developed in collaboration with the Sponsor in order to fulfil Sponsor requirements and objectives. All protocols are written with input from Cmed CS’s medical and regulatory team.
The Clinical Study Report is the final deliverable and the one document for which the study will be remembered. Our experienced Medical Writing team works alongside the clinical, data management and statistical analysis team throughout the study to ensure accurate representation of data and results of the clinical study.
All of our reports are written to ICH guidelines and undergo a full process of comment integration, QC and review. Cmed CS can use its standard templates or those of the sponsor company.
We understand the value of strong project management and a flexible working relationship. We will:
- work remotely or face-to-face
- integrate with your project team
- work independently yet collaboratively
- maintain client confidentiality at all times
Our proactive writing strategy means that you can:
- depend on us to meet your timelines
- trust us to stay within budget
We can offer services covering:
Regulatory Documentation
- Common Technical Document (clinical overview (expert report), clinical summaries)
- NDA to MAA conversions, supplemental NDAs, NDAs in CTD format
- risk management plans
- clinical study reports (phase I-IV)
- serious adverse event narratives
- clinical evaluation reports
- periodic safety update reports
- nonclinical reports
- PIP
- IMPD
- ICFs
Clinical Trials Documentation
- clinical development plans
- protocols
- amendments
- investigator brochures and updates
