MedLexicon

MedLexicon is a company based in Russia, Moscow, specializing in the development and review of localized country-specific regulatory packages on all phases of clinical drug development.

This includes:

• preparing files submitted to regulatory authorities in support of a request to authorize a biomedical study in humans (or animals)
• developing national master or site-specific versions of documentation given to study subjects
• validation of tools used to quantify Patient Reported Outcomes and Quality of Life measures
• maintaining Investigators' Site Files and Trial Master Files and providing standardized documents required before, during and after the study,
• developing study-specific forms, depending on the specific study design and objectives,
• help in audits (independent review), site visits, Investigators' meetings, Q&A logs
• medical writing of clinical study protocols, Investigator's Brochures, safety summaries or case narratives/listings
• processing all kinds of safety reports (from initial SAE narratives on a site-level to CIOMS/MedWatch notifications) on an expedited basis
• transforming raw and scattered technical data into summaries of manufacturing process of formulation compliance testing
• involvement at the most important stages of a compound registration dossier in pursue of a marketing authorization
• verification, reviewing and updating pre-existing documents
• recommendation on any outstanding deficiencies and implementation of corrective action to bring a regulatory approval forward

...and many more related functions.

Additionally, we perform oral medical translations.

The company is operating on Russian, Ukrainian, Belarusian and Lithuanian markets.

Contact us at info@medlexicon.net