Over 25 years’ statistical experience in strategic drug development, direct interactions with FDA, EMA, MHLW and regulatory authorities worldwide, clinical program design, clinical statistical analysis and reporting.
Generating the right data from the right trial and programme design is at the heart of successful drug development. Navigating the subsequent regulatory process from submission through to approval and beyond requires experienced, considered statistical judgement.
Successful projects are characterised by the quality, experience and commitment of the experts leading them. With support from KJC Statistics you can be assured that the highest level of statistical expertise and commitment will be maintained throughout, as your success is our success.
I have worked with Kevin for several years and recently we have been collaborating on several trials in my oncology program. Kevin is the iDMC senior independent statistician on several studies and is the Chair on one of them. Kevin stands out by his deep experience and knowledge of oncology, his outstanding expertise in clinical development and trial design challenges and his unique awareness of the ever changing regulatory environment and drug approvals. I am delighted to collaborate with Kevin and the huge value he brings to our oncology portfolio.
We were very pleased with Kevin's input into the Wellcome application. It was to the point, professional and responsive to our time constraints.
Kevin has shown himself to be 'Master of the story hidden beneath the numbers'. We were looking for help to simplify the content of slides that described complex statistical techniques and Kevin was the person we turned to. With very little notice he was willing and able to help us. Not only did our content improve, we learned a great deal too.
I have recently had the pleasure of working with Kevin on a phase IIIB oncology study, where Kevin has performed the role of independent statistician on the Independent Data Monitoring Committee. Kevin has provided thorough and useful feedback in a very timely fashion, and is professional, responsive and clear in his communication, both written and verbal. It's been a pleasure working with him.
The input provided by Kevin to the task set was professional, considered and highly relevant. From the outset, I was reassured that he fully understood the brief and was impressed by the knowledge and experience that he was able to leverage to help provide a solution. The output Kevin provided will add real value to our organisation, by enabling us to make informed and rationalised decisions.