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Maintaining Continuity of Clinical Studies of a New Drug

Task

Developing legal methods for contactless delivery of drugs to patients in line with the dedicated clinical investigation plan

Client
Federal clinical centre
Industry
Public health

Background

Governmental authorities re-formatted the medical institution to accept only those people who are infected with CoVID-19.

Due to the restricted access, those patients taking outpatient treatment were unable to visit their doctors to take drug courses, resulting in suspension of the related clinical studies, violation of the investigation procedures and an impact on the relevance of the drug property data.

Outcome

RussianLegal developed and caused to be approved a drug supply procedure involving a forwarding intermediary using digital delivery confirmation methods to comply with the protocol.

The client became able to complete Phase IIb of its two-year clinical studies without violating the Russian Health Ministry’s requirements and to introduce a new drug to the market.