15 Nov, 2010

Dokumeds has added additional Specialty Services:

Non-interventional / Observational Studies

Full scope services from protocol draft to final report. Our knowledge of countryspecific legislation and procedures as well as long term reliable collaboration with local KOL (Key Opinion Leaders) serve as basis for successful project execution.

Marketing Authorization

Considering clinical trials as part of marketing approval in Russia, DOKUMEDS focuses its services on regulatory consultancy and marketing authorization handling.

Pharmacovigilance services

Handling of adverse events and adverse drug reactions during clinical development and post-authorization · MedDRA coding · Assessment of seriousness · Expectedness and causality · Expedited and periodic reporting · Literature search · Contacts with local agencies · Medical support

Medical Translations

DOKUMEDS translation services are particularly aimed at medical and pharmaceutical translations, covering wide-range of specialty materials. All translations are done by highly experienced personnel and meet best standards of accuracy, timelines and quality.