This service entails the generation of well-structured individual reports to extensive medical writing programs, including:
1. SAE Narratives (CSR, DSMBs etc.)
2. Clinical Study Protocols
3. Clinical Study Reports (ICH-E3)
4. IND Annual Reports (21 CFR 312.33)
5. Clinical Summaries/Product Feasibility Reports for Medical Devices
6. Manuscripts and Publications
7. Patient Diary Cards (PDC), Informed Consent Form (ICF), Subject Information Sheet (SIS), Case
Report Forms (CRFs)
Our medical writers have a strong academic; pharmaceutical and biotechnology industry background and can help you prepare clear, concise, and high quality;
Case Report Form
Patient information leaflets
Informed Consent Form
Safety data reports
Medical translation services
Study related Forms and Logs
Experienced Medical Writing Professionals at Synmeta LLC can design and write a wide range of high quality clinical trial documents in your style / format, efficiently within the prescribed timelines. The department has the experience necessary to deal with the unique challenges of a clinical trial; our medical writing services span across all departments, assimilating information from a wide range of expertise.
Your success results from reduced clinical development time with possible fewer patients and lower costs than expected due to our proven Medical Writing structure.
We can assist you with:
Protocol Development, designing of Screening Form and CRF:
Expert review and reports of Safety data:
Statistical Analysis and Report.