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Since clinical trials are extraordinarily expensive and addendum to ICH GCP E6 R2 recommends to “encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting”, as well as to use risk-based approach when planning the activities in clinical trials, industry must move forward and utilize efficient procedures in any possible area. One of the ways to optimize is shared audit. Shared audit is […]
Recently more and more Russian pharmaceutical companies are beginning to use specialised Clinical Trial Management Systems (CTMS). In Europe and USA use of CTMS has long become an expected ingredient of high quality clinical trial management. In Russia such systems have not yet gained widespread use. One of the first Russian pharmaceutical companies to introduce a CTMS system was Pharmasyntez, who has been working with a Russian clinical software company […]