Clinical Trial Biostatistics and Analysis

Providing high-level consulting support for clinical program, and ensuring statistical deliverables with the highest quality and efficiency.

Biostatistical & Analysis Services

Biostatistical analysis is an integral component of the overall service offering of WCCT Global. From conception of a program or study, we can provide consulting on study design and analytical strategy which keeps in mind the most precise way to address study objectives within the current regulatory landscape.

WCCT’s biostatistical programmers have deep experience in all phase of drug development. We provide specific support that is imperative for early phase trials such as Pharmacokinetic and Pharmacodynamic analysis. For late phase trials, we provide independent Data Monitoring Committee support by helping select the voting statistician on the committee and by providing statistical analyses to the committee to evaluate the interim evidence.

For the overall program, we create submission packages by helping to prepare the overall storyboard, drafting the integrated documents, as well as preparing regulatory presentations. We also respond to regulatory questions in writing and seek feedback from the agencies in-person.

WCCT’s biostatistical services include:

• Statistical consulting on project development plans
• Preparing protocol sections
• Statistical Analysis plans
• Writing statistical sections of Clinical Study Reports
• Preparation of CDISC-compliant datasets (SDTM and ADaM) and statistical outputs for study reports
• Pharmacokinetic analysis
• PK/PD modeling
• Representation at regulatory agencies such as the FDA, EMA, PMDA, and others
• Data Monitoring Committee Support
• Regulatory responses

WCCT’s Biostatistical Team

Biostatistics is one of the cornerstones of regulatory assessment of submissions, and thus, it is essential that sponsors have a knowledgeable group supporting any specific study or program. Our team of biostatisticians is comprised of personnel with over 70 combined years working in the pharmaceutical industry. They have been directly involved in successfully collaborating with other functions, evaluating programs at the portfolio level, and negotiating with regulators on behalf of sponsor companies. Additionally, they have also managed teams to provide operational support numerous submissions. We believe our vision from a strategic viewpoint sets us apart.