We collaborate with organizations as they establish and broaden their research agenda and identity.

For new biotechnology firms with in-house statistical departments, we provide consultation on the design and analysis of preclinical, Phase I, and Phase II studies. As young companies grow, we help them find new staff statisticians. We provide guidance and statistical expertise in the preparation of protocols for clinical trials, and we consult with scientists and clinicians in the process of drug development. Here is a sampling of these projects:

• For a small biotechnology company with expertise in neurological disease, we helped develop Phase I studies, Phase II/III studies, and compassionate use studies. We worked closely with the director of medical affairs, the in-house statistician, and the outside investigators. We co-authored peer-reviewed scientific papers.
• For a large biotechnology company with expertise in cancer research, we are responsible for statistical design for pre-clinical and Phase I studies.
• As statistical consultants to a young biotechnology company specializing in infectious disease, we worked with the staff statisticians to develop protocols and with the staff clinicians to prepare reports. A meta-analysis we designed and performed in conjunction with the staff of the company was presented at the annual meeting of a major infectious disease professional society.

For several international cardiovascular device companies, we have provided the statistical design, protocol development, and analysis of device studies. The devices have included defibrillators, stents, and artificial heart valves.

For large pharmaceutical companies, we provide an independent, critical eye for reviewing protocols, analytic plans, and submissions to the Food and Drug Administration (FDA). We analyze datasets that pose particular problems. We perform meta-analyses and analyses of trials whose results are difficult to interpret. For example, for several large pharmaceutical companies:

• We have provided statistical review of major drug development programs.
• We have participated in mock FDA panels, playing the role of FDA panelists.

For government agencies, we help design, analyze, and interpret research studies. We offer statistical support for preparing abstracts and manuscripts. We also provide independent assessments of current and past studies. For example:

• For the USDA, we provide sensory evaluation analyses on an ongoing basis to help determine how food should be cooked for school lunches.
• We serve as the statistical consulting group for the research studies of the NationalInstitutes of Health Critical Care department.
• For the Walter Reed Army Institute of Research, we are the statistical coordinating center for malaria vaccine studies.
• For the Department of Veterans Affairs, we consult on studies conducted through the Cooperative Studies Program Coordinating Centers.

For a non-profit organization developing a new research program, we served as the statistical center for the development of clinical studies of HIV and for an observational database study of HIV disease.