Medical Writing

Clear. Compliant. Scientifically Sound.

At mediSMART, our Medical Writing Services are designed to support sponsors and CROs throughout the entire clinical development lifecycle. From early-phase protocols to final study reports and regulatory submissions, we deliver accurate, high-quality, and submission-ready documents that meet global standards.

Our Services Include:

📄 Regulatory & Clinical Trial Documents

• Clinical Study Protocols & Amendments
• Investigator's Brochures (IBs)
• Clinical Study Reports (CSRs)
• Informed Consent Forms (ICFs)
• IMP Dossiers and Product Information Documents

📢 Scientific & Medical Communications

• Abstracts, Posters, and Slide Decks
• Manuscripts for peer-reviewed journals
• Literature reviews and publication support
• Medical content for educational or promotional use

📨 Submission & Compliance Documents

• Common Technical Document (CTD) modules
• Risk Management Plans and Safety Reports
• Briefing documents for regulatory agencies
• Responses to regulatory queries

Why mediSMART?

• ✅ Scientifically accurate
• ✅ Well-structured and clearly written
• ✅ Compliant with ICH-GCP and regional regulatory requirements
• ✅ Tailored to the target audience – whether regulatory agencies, investigators, or patients

We collaborate closely with clinical, regulatory, and safety teams to deliver content that drives understanding, supports decision-making, and ensures smooth progress of your clinical development programs.