Medical Writing Services

Medical Writing Services-44
Writers are qualified to the MSc or Ph D level, and they possess full knowledge of industry guidelines and vast experience in writing and editing medical documentation.

Writers are qualified to the MSc or Ph D level, and they possess full knowledge of industry guidelines and vast experience in writing and editing medical documentation.

Medical Writing is a vital segment of clinical research.

It plays a critical role in the development and submission of clinical research documents and defines the success or failure of new medicinal products/devices.

Writers undergo regular training conducted by the EMWA (European Medical Writers Association), the AMWA (American Medical Writers Association) and other recognized medical writing organisations to keep their skills at the vanguard of the medical-writing field.

Felicitous and competent documentation is vital for the success of clinical development program.

They possess strong project management and negotiation skills and support projects with multiple customer contributors and external thought leaders.

They drive timelines, organize and lead authoring meetings, and reconcile sponsor feedback across functions to create consistent, scientifically cohesive documents and minimize nonessential customer oversight.

We draft wide range of documents for clinical trial submissions and other regulatory documents yoke with clinical research.

The documents we cover are investigators’ brochures, study protocols, Informed consent, patient narratives, safety narratives, CSRs, selected e CTD modules, development safety update reports (DSURs), periodic safety update reports (PSURs) and annual safety reports (ASRs).

We also cover all phases of clinical trials over all with bioequivalence and preclinical.

Our writers has executed high end quality documents ranging from IBs and clinical trial protocols, through clinical narratives , aggregate reports like DSURs / ASRs to CSRs and e CTD components.


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