Medical Writing
The success of a clinical development program 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’s expectations and designing protocols. Our writers with a strong scientific background and therapeutic area-specific knowledge ensure accurate and well-written submission-ready documents.
Clinical study protocol development
Clinical Trial protocols (Phase I, II, III & IV)
PK & BA/BE studies (Both Healthy and Patient studies)
Pharmacokinetics & Pharmacodynamics (PK/PD)
Glucose Clamp studies
Trial related essential documents
Case report forms (CRF)
Informed Consent Documents (ICD)
Investigator brochure (IB)
Patient Information Sheets (PIS)
Patient diaries (PD)
Clinical & Non-Clinical overview writing
Clinical overviews
Non-Clinical Overviews
Safety aggregate reports
Periodic Adverse Drug Experiences Report (PADER)
Periodic Benefit-Risk Evaluation Report (PBRER)
Periodical Safety Update Report (PSUR)
Drug Safety Update Reports DSUR
Risk Management Plan (RMPs)