Clear, concise and structured scientific writing to help companies with drug development and post approval documentation
Effective medical writing is critical in ensuring success toward authoring clinical documents for submission as well as for post approval requirements. Such documents not only help healthcare professionals, but are also required by regulatory bodies to ensure safety and efficacy of medicinal products that are developed or marketed. High quality, scientific writing helps in the growth of medicinal products.
With an increased regulatory rigor on transparency in sharing clinical data and pharmacovigilance strategies during clinical development, the demand for writing services is surging rapidly. Wipro’s medical writers have extensive experience in authoring a variety of documents, clinical or non-clinical, regulatory or safety documents, which are spread across a wide range of therapeutic areas, across phases of development and through all product types. Our team of medical writers can deliver quality documents with quick turnaround time and help accelerate your submissions. Our team of medical writers and SMEs (subject matter experts) are highly skilled professionals and possess thorough understanding of the drug development process, ICH-GCP regulatory guidelines and rules across different geographies, thus providing clear and concise scientific documents. We provide end-to-end services across product lifecycle with flexible resourcing model to provide significant cost benefits to our clients.
Wipro can assist your company with all your Medical Writing requirements:
- Authoring of clinical documents such as clinical study protocols, clinical study reports, Investigator’s Brochures (IBs) and updates, clinical common technical components, risk management plans, Top Line Summary (TLS), Informed Consent Forms (ICFs), Case Research Forms (CRFs)
- Non-clinical summaries and overviews, protocols and non-clinical study report
- Develop, review, update and manage Clinical Overviews (CO)/Justification Documents (JD), Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE)
- Safety reports – PSURs, PBRERs, PADERs, DSURs, RMPs, XEVPRM and post-approval safety studies (PASS)
- Toxicology and Permitted Daily Exposure (PDE) reports
- Writing abstracts, journals, manuscripts for required therapeutic area
- Curation of scientific content for slide decks, brochures, posters, educational material for healthcare professionals