WCG statisticians are scientific partners who work alongside scientists from other disciplines to develop interventions for the prevention and treatment of disease. By their nature, statisticians question data and design and sometimes challenge whether other possibilities lurk behind the obvious explanations.

We assist biopharmaceutical and medical device sponsors in all statistical areas of trial design and regulatory strategy, including:

Statistical Review of Protocols

SAP Authoring and Review

Final Analysis

Regulatory (FDA/EMA) Meeting Support

Statistician Outsourcing

Analysis Support for Publications and Research Programs

Study Design Support

Due Diligence Review

Clinical Outcome Assessment (COA) Support

Sensitivity Analyses

Simulation Studies

Meta Analysis

Statistical Capabilities

Our statistical experts conduct original research in statistics resulting in significant contributions to the scientific literature. This includes applying both recently developed and conventional statistical methods to the wide range of study designs encountered in biomedical research.

We help sponsors with:

Clinical trial methodology

Survival analysis

Experimental design

Longitudinal data analysis

Development and assessment of decision rules

Meta-analysis to combine data across studies

Real world evidence (RWE) analysis

Who Needs Statistical Consulting Solutions?

For new biotechnology firms with or without in-house statistical capabilities, we provide consultation on the design and analysis of clinical trials across development programs ranging from Phase I to Phase IV.

Clients utilize our guidance and statistical expertise in preparing protocols for clinical trials. We consult with scientists and clinicians on the development of therapies— and as young companies grow, we help them find new staff statisticians.

We work with:

Small to large biotechnology companies

Pharmaceutical companies

Medical device companies

Government agencies

Non-profit organizations

Statistical Consulting FAQs

WCG works with our clients throughout the life cycle of study development. Our statisticians provide an experienced perspective on the entire process, starting from the initial stages of defining endpoints, writing protocols, calculating sample sizes, designing case report forms, and continuing to the later phases of analysis, interpretation, and regulatory submission.

We are most effective when we begin working with the study team early in the process, but we also have considerable experience joining project teams during an ongoing study or after an unsuccessful regulatory submission.

WCG often reviews analyses performed by others. We may simply review the methodology to see if it is appropriate for the question asked and the data collected.

We may suggest other methods of analysis that take into consideration the disease under study, the conduct of the trial, or issues with the data. In many cases, clients provide us with the data and we perform our own analyses and write a summary report.

Yes. We have worked with many clients on the statistical analyses for New Drug Application (NDA), Biologics License Application (BLA),, and medical device submissions to the FDA. We also have experience supporting submissions to international Health Authorities (e.g., EMA, MHRA, Health Canada, MHLW, NMPA). We are familiar with Central Data Interchange Standards Consortium (CDISC) data standards and have experienced programmers who can develop SDTM and ADaM datasets along with the required data documentation.