Medical/Safety Writing Content Development
Nucleon is one of the best CRO which has a vast experience and global exposure in providing high quality clinical study documents which are compliant with regulatory requirements and ICH guidelines. Our experienced medical writers have experience working in a broad range of indications and therapeutic areas.
Our clinical writing process involves a sequence of scientific, statistical and editorial managerial and quality control reviews at each developmental step. From the initiation of a project to the final document, Nucleon maintains a high level of communications with you, ensuring that the document content and format fully meet your expectations and requirements. Nucleon’s medical writing services include clinical and regulatory writing as well as scientific communications, educational material and medical writing consultancy.
- Unique blend of medically qualified skilled MWs (post-graduates, PhD holders and pharmacists) hailing from various Pharma backgrounds.
- 15 + Therapeutics Area Covered
- 2000 + Documents Submitted to various Regulatory bodies
Medical Writing Services Include
- Investigator brochure, Clinical Study Protocol / Protocol Amendments, & ICDs
- SAE Narratives, DBL Review, Shell CSR & Mock Table Review.
- Clinical Study Reports (Full and abbreviated) with Appendices
- Common Technical Document Modules
Regulatory Writing Offering
Safety Writing
- Aggregate Reports (DSUR/ PBRER / PSUR / PADER / SUSAR)
- Risk Management Plan (RMPs)
- Risk Management & REMS Strategies
We prepare documents as per the specific journal/conference guidelines or as per the client requirements. Our writers understand your research goals and ensure that your scientific results and ideas are conveyed accurately to maximize the impact of written documents. Services Includes:
- Publication planning & Writing of Manuscripts
- Review articles, Abstracts, Posters, & Slide Decks
- Literature Reviews
- Medico Marketing Documents