Medical Writing
Medical writers are critical to the communication process of outlining the goals, strategies, analysis and medical understanding of a clinical trial/program to patients, sites, sponsors and regulatory agencies.
Manage constantly evolving regulatory protocols and submission guidelines with our experts. Get collaborative, affordable support for clinical, data management, and biostatistics groups — whether you need minimal support or a whole team. From study design – protocol development to regulatory support to publishing, our expertly prepared reports comply with local and ICH guidelines.
Our experts support writing and regulatory services to ensure complete, compliant, and high-quality deliverables. Receive documents that have undergone rigorous scientific, statistical, editorial, and quality control review, compliant with FDA, EMA, and other regulatory requirements.
NovoBliss’s services cover medical and regulatory writing, scientific communications, and publishing. These services include:
Medical Writing
- Study protocols and design
- ICH and GCP compliant clinical study reports (CSRs)
- Including CSR synopses for public disclosure
- Clinical and non-clinical sections of the Common Technical Document (CTD)
- Investigator Brochures
- Patient safety narratives
- Patient/Study participants information
- Informed consent brochures
- Patient brochures
- Assent Forms
- Parental Consent Documents
- Advertisements
- Patient Diary
- Clinical trial registration and results postings on clinicaltrials.gov. and Clinical trial registry of India (CTRI)
- Standard Operating Procedures (SOPs)
- Covering all aspects of drug development including clinical trial design, conduct, and reporting, and the outsourcing of sponsor responsibilities to a clinical research organization (CRO)
Scientific Communications
- Conference materials
- Abstracts
- Poster presentations
- Slide decks
- Manuscripts
- Editorial support
- Journal/conference submission
- Website content
- Both scientific and patient audiences
- Educational material for patients, healthcare professionals, and pharmaceutical industry personnel