Medical Writing Services

Medical writing counts in creating well-structured scientific documents, documents for journals, clinical research documents. It can be either regulatory medical writing or educational medical writing.

Medical writing in the context of Clinical Research undoubtedly plays a crucial role in the success or failure of new compounds.

Innayat CRO Medical Writing Services is well equipped with professionals having strong academics besides having valuable scientific experience in various therapeutic areas; help to compile, organize, write, edit and produce a wide range of medical and scientific documentation essential to deliver the quality and timeliness required to support the product development efforts.

Our clients can safely bank on our writers at any stage in their product development lifecycle – from clinical development plans and investigator brochures to regulatory submission and licensing maintenance documents. Having in-house expertise from PK|PD to pharmaco-vigilance, we are capable to work on study reports, patient narratives, DSMB updates, labeling, or other documents involving study data.

The Medical Writing services at Innayat CRO are proficient in:

• Clinical development plans
• Abstracts, manuscripts, and journal articles
• Investigator brochures and annual updates
• Informed consent forms
• Protocols
• Clinical study reports
• Clinical sections of Common Technical Documents (CTDs)
• Clinical sections of New Drug Applications (NDAs)
• Periodic Safety Update Reports (PSURs) and other pharmaco-vigilance documents
• Pre-FDA meeting briefing documents
• Response to clinical hold orders
• Preclinical study reports, expert reports, and summaries
• Data Safety Monitoring Board (DSMB) manuals
• Written and tabular summaries

Bio-Analytical Reporting

• Method Validation Reports
• Bioanalytical Reports
• ISR Reports
• Submission-ready Documentation (Hyperlinked eCTD formatting)
• Dispatch & Archival
• Benefit | Risk assessment reports apart from medical and scientific literature reviews

Our unique medical writing offerings are in strict adherence to ICH guidelines and similar regulatory requirements.