Medical Writing

Regulatory Medical Writing

Providing a powerful and scalable medical-writing solution is one of our core strengths at Acuity Clinical. We are a global organization with Head office in Ahmedabad.
Clinical Study reports (ICH-E3 compliant)
Study protocols and amendments
Investigator’s brochures and updates
Informed consent documents
Clinical sections (Modules 2.5, 2.7 and 5.0) of CTD submission
Non-clinical sections (Modules 2.4, 2.6, and 4.0) of CTD submission
Standalone QC and review of documents
Patient/study-related materials like advertisements, patient cards, patient diaries
Regulatory responses
Briefing books/documents

Safety Medical Writing

Acuity Clinical is a team of experts’ exclusively specializing in CTD modules and Risk Management Plans (RMPs) with in Medical Writing.
Addendum to the clinical overview (ACO)
DSURs
PSURs
PBRERs
PDERS
Risk management plans (RMPs)

Scientific Writing

Acuity Clinical have highly skilled writers with a decade of experience in clinical and regulatory affairs area.
Systematic literature search
Publication planning
Original research manuscripts
Literature Reviews – narrative, systematic and meta-analysis
Manuscript review and editing