Medical Writing
The success of a clinical development programme depends on the proper documentation of research plans and results. We offer a range of flexible medical writing services to support various clinical study documentation needs. Our medical writers are trained and experienced in understanding the client expectations and designing protocols. Our writers’ with strong scientific background and therapeutic area-specific knowledge to ensures accurate and well-written submission-ready documents.
Clinical study protocol development
1. Clinical Trial protocols (Phase I, II, III & IV)
2. PK & BA/BE studies (Both Healthy and Patient studies)
3. Pharmacokinetics & Pharmacodynamics (PK/PD)
4. Glucose Clamp studies
Trial related essential documents
1. Case report forms (CRF)
2. Informed Consent Documents (ICD)
3. Investigator brochure (IB)
4. Patient Information Sheets (PIS)
5. Patient diaries (PD)
Clinical & Non-Clinical overview writing
1. Clinical overviews
2. Non-Clinical Overviews
Safety aggregate reports
1. Periodic Adverse Drug Experiences Report (PADER)
2. Periodic Benefit Risk Evaluation Report (PBRER)
3. Periodical Safety Update Report (PSUR)
4. Drug Safety Update Reports DSUR
5. Risk Management Plan (RMPs)