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Medical Writing

Medical writing is integral part of our working. Auriga Research Ltd offers medical writing services for bioavailability/bioequivalence studies, Phase I to IV clinical trial, Post-marketing studies and also for regulatory dossier preparation which include study protocol, investigator brochure, CRF, ICF, work-practice documents (WPDs), expert reports etc. Most of these medical writing jobs is inbuilt into study project but can be offered as stand-alone basis. We have so far developed more than 150 study protocols and clinical study reports which include both BA/BE and phase trials.

Our medical writing team consists of MBBS, M.D., Master in pharmacy and life science. The review process of all documents is very rigorous to have a finest quality of documentation. We also make sure the delivery of documents before the timeline.

Further we have also prepared lot of expert reports of different pharmaceuticals products for regulatory submission which is basically compilation of clinical, pharmacological and toxicological information available in literature. We have also prepared periodic safety update reports (PSURs) of products which are prepared from the safety data collected during post-marketing stage.

We are closely working with hospital sites and investigators for conducting registry study which includes compilation of data from medical records. This data is then statistically analysed and converted to manuscripts & posters.

With the brief detail on our capabilities on medical writing we request you to share your query on the same to assist you better

We have also published the clinical studies conducted by us as web-link below.

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