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Statistical due diligence for a CNS asset for an investors' group.
Statistical support for a mid-size biotech on the clinical program in a rare dermatological disease that included FDA interactions on a sequential design and multiplicity control.
Statistical advice on a design for a phase 2 study in a rare skin disease for a start-up biotech..
Adaptive design for a small biotech's kidney disease study with a different primary endpoint in the US vs. Europe.
Design and statistical analysis plans for two patient registries that are a part of a mid-size biotech's post-marketing commitment to the FDA. Challenges focused on balancing the non-interventional nature of the registries with increasing regulatory requirements including a formal sample size calculations and a stringent statistical analysis.
Eva is currently serving as an independent statistician on two Data Safety and Monitoring Boards for gene therapy clinical trials ran by a mid-size biotech company.
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