Apothecaries Clinical Research




A group of our experienced medical writers are assigned to each project for its entirety. Our medical writers along with the regulatory staff ensure that each document meets the internal requirements and specifications as well as those of Indian regulatory authorities. All regulatory documents undergo an independent quality assurance review by an internal QA staff prior to being released as final.

The medical writing associates at Apothecaries specialize in building objective, comprehensive and reliable clinical trial documents which include:

• Clinical Study Reports (as per ICH guidelines) • Case Record Forms and Patient Diaries • Site Feasibility Reports • Regulatory Dossiers for registration of drugs and medical devices • New Drug Applications • Protocols • Investigational Brochures • Product Monographs • Informed Consent Documents • Quality Control Services • Pharm-Tox Expert Reports • Scientific Papers for Publication • Preparation of SPCs and Package Leaflets • Development of Database • Translated Patient Materials • Tabulated Summaries • Clinical and Nonclinical STD Modules • Benefit Risk Assessment Reports • Operating Procedures & Working Practice Documents. • Literature reviews • Meeting Reports • Training Material