Statistical Consulting: Clinical trials
Introduction
From the initial phase of drug development to registration, biostatistics for clinical trials is essential. L-Biostat is an institute located at the Katholieke Universiteit Leuven with an international reputation in both theoretical and applied biostatistics and in the conduct of clinical trials. Our team consists of statisticians who work in collaboration with computer scientists and medical doctors. We offer a wide variety of quality services for the pharmaceutical industry, with high standards on both quality and deadlines. The Centre has experience in clinical trials in many domains including cardiology, central nervous system, dermatology, endocrinology, nephrology, nuclear medicine, pneumology, bacteriology, etc.
For more details, please contact Dr. Kris Bogaerts.
L-Biostat stands for accuracy and speed in
- Clinical Trial Design
- Data Safety and Monitoring Board (DSMB) assistance
- Data Analysis and Reporting
- Consultancy
Clinical Trial Design
A good clinical trial begins with a good design. L-Biostat offers advice on designing phase I, II, III and IV clinical trials. This includes the selection of the clinical end points and rating scales, the experimental design, the sample size calculations, the design of the case report form and more.
DSMB assistance
L-Biostat can serve as an independent group who is repsonsible for the creation of the statistical tables and listings for the review of the Data Safety and Monitoring Board (DSMB) of the clinical trial. We can be a liason between the sponsor and DSMB or if requested, one of our statisticians can be a formal member of the DSMB.
Data Analysis and Reporting
Making reliable information out of clinical data is the mission of L-Biostat. L-Biostat has an academic reputation in theoretical and applied biostatistics especially in the domains of mixed models, drop-outs and logistic regression. The Centre has numerous publications in major statistical and medical journals like Biometrics, Journal of the American Statistical Association, Journals of the Royal Statistical Society, Statistics in Medicine, New England Journal of Medicine, Circulation etc. Data are analyzed with state of the art software like SAS, Splus, StatXact, etc. L-Biostat prepares integrated clinical reports consisting of text, tables and graphs, tailored according to the clients' demands and assuring high quality. These reports can be used for registration of new or generic drugs at national and international organizations or for scientific publication.
Consultancy
We offer advice on design (sample size calculation), data management, data analysis and reporting of clinical trials. L-Biostat has experience in clinical trials in different medical specialities including cardiology, central nervous system, dermatology, endocrinology, nephrology, pneumology, nuclear medicine, bacteriology, etc.
