The success of a clinical development program depends on the proper documentation of research plans and results. ICBio offers a range of flexible Medical Writing services and Document Publishing services to support various clinical study documentation needs along with the project management services
ICBio has a team of experienced medical writers with scientific expertise to provide high quality clinical study documents (including eCTDs) compliant with ICH guidelines and regulatory requirements. From protocol writing to the final study report preparation, our medical writers coordinates with biostatisticians and project team members to produce comprehensive, submission-ready documents for all stages of clinical development. We provide medical writing services as part of clinical trial program or as a stand-alone service.
Our team of writers has experience working in a broad range of indications and therapeutic areas. ICBio Medical Writing team offers flexible solutions for single documents or an entire multi-study program and all these effective output made ICBio as one of the prominent medical writing companies.
Our Medical Writers can assist at any point in the product development from Phase I to Phase IV, and have experience in a wide array of documents, including
- clinical study protocol development
- Investigator Brochures
- clinical study reports
- patient narratives
- DSMB updates
- regulatory submissions and other documents involving study data
- Case report forms
- Abstracts and manuscripts
Clinical overview and clinical summary (sections 2.5 and 2.7 of CTD) As one among the top medical writing companies our Medical Writing services follow ICH guidelines and are compatible with regulatory requirements. We fulfill the requirements of other premier CRO in India and help the companies or organizations offering clinical trials services in India.
Our document publishing team vast experience and many are certified in several software applications used for electronic Publishing.