For a start up biotech company in advance of its first filing, we conducted an assessment of its clinical compliance. The client wanted to be aware of any gaps in its Clinical program as well as adoption of ICH E6 (R2) standards, in order to be prepared for regulatory agency inspections. As part of the assessment we identified gaps in process and procedures which we helped to address prior to filing.
For a mid-sized pharma company, DArcy Consulting established business processes for a number of the client’s key clinical processes including Protocol, Informed Consent, CSR as well as Statistical Analysis Plans.
For a start up biotech, we conducted an assessment of its TMF. We also created a set of Inspection Readiness Guidelines.
For a company that received a warning letter, we undertook a complete review of its Biometrics function (Data management, Statistics and Statistical Programing). As a result of an internal survey, we were able to identify specific gaps and put in place solutions to address gaps (structure, training, SOPs).