Arete | Medical and Report Writing

	India
1)	Central Drugs Standard Control Organization (CDSCO)

2)	Indian Council of Medical Research (ICMR)

3)	Department of Biotechnology (DBT)

	International

1)	U.S. FDA

2)	Center watch

3)	International Conference on Harmonization (ICH)

	What We Do

	Clinical Trial Design & Management \| Clinical Monitoring \| Regulatory Affairs \| Biostatistics

	HR Augmentation \| Medical and report writing \| Auditing and Expert consultation services \| Strategic Alliances

	Additional support services
	Clinical Research Document like : Phase 1- 4 Protocol synopsis, protocol, CRF, ICF, Investigator fesiblity, Clinical Study Report etc. Medical Writing - Common Technical Document ( CTD) for any Regulatory Submission, PI infomation, IB - version changes, Safety Narrative writing, Drug Monograph, PPT Slides etc. Pharmacovigilance - PSUR, ( Periodic Safety Update Report) PADER (Periodic Adverse Drug Experince Report) ASR ( Annual Safety Report) SBR ( Summary Bridging Report) DSUR ( Drur Safety Update Report) etc.