|
I specialise in a full range of scientific and regulatory medical writing documents that includes drafting, designing, and reviewing of the following documents on Phase I-IV trials:
- Clinical Trial Reports including abbreviated reports for observational studies
- Patient Informed Consent forms
- Case Report Form and Diary Card design (paper format)
- Patient Questionnaires and Survey Reply forms
- Drafting, review and submission of Scientific Letters and Research Papers
- Drafting of Regulatory Progress Reports
- Performing of quality control and medical writing peer reviews on clinical trial documents
I draft and edit all documents according to client specifications, but I also design and provide document templates for clients who do not have their own standard templates.
All documents are designed according to ICH GCP guidelines and other regulatory requirements and conform to the Standard Operating Procedures of my business and/or the internal operating procedures of the client.
| 
Specialised Services