Expert Statistical representation at regulatory authority meetings
With extensive experience representing statistical and drug development issues to regulatory authorities worldwide, including the US FDA, Japanese (MHLW), UK (MHRA), Canadian (Health Canada), German (BfArM), Sweden (MPA), Spanish (AEMPS), French (AFSSAPS), Dutch (MEB), Australian (TGA) and Swiss (SwissMedic), KJC Statistics can offer truly experienced support to help secure a successful regulatory interaction for your project.
Support preparing for FDA Advisory Committee meetings and EU Oral Explanations including statistical speaker & Q/A training
In addition to supporting health authority meetings, KJC Statistics has unique industry statistical experience in directly presenting critical data and scientific issues at multiple FDA Advisory Committee meetings as well as experience with MHLW Open Public Hearings and EU Oral hearings. As part of supporting your project through these very challenging meetings, KJC Statistics can further offer critical speaker training and Q/A preparation to put you and your team in the best possible shape to succeed.
Expert IDMC Statistician
KJC Statistics offers a high level of technical expertise and know-how coupled with experience and judgement gained through over 15 years hands on involvement with IDMCs and trial Steering Committees.
In-licensing Support – Due Diligence of Critical Trial Data and Critique of Proposed Clinical Programme Design
In-licensing represents a major investment decision for your company. Often timelines to make a deal are very tight, squeezing into a narrow window the time available to complete critical due-diligence activities. KJC Statistics has deep experience of time pressured clinical due diligence assessment and what critical items to examine and stones to turn over in the limited time available. In this way, KJC Statistics will help you and your company to make the right, fully informed decision to invest or not.