Biostatistics

Biostatistics is one of the key elements in any successful clinical study. Phase V Technologies (PVT) has a strong biostatistical tradition stemming from its close ties to the Department of Biostatistics at Harvard's School of Public Health. At PVT, we have extensive experience in biostatistical methods for all aspects of a clinical trial from planning through to the writing of a manuscript for a journal submission.

PVT has focused most of its energy on research in the fields of health economics, quality of care and patient-reported outcomes (PRO), including quality of life and treatment satisfaction, and prides itself in acheiving the best possible product in these areas. The field of patient-reported outcomes is different from most other study endpoints found in clinical trials because of the latent or unobservable nature of the endpoints of interest. Surveys used to gauge these latent constructs resemble the instruments used in psychological studies and require a different set of methods not typically associated with biostatistics. PVT has developed statistical and clinical expertise on the design and administration of PRO questionnaires in clinical trials and can provide you with the validated Phase V® Outcomes System and will work with your team to modify the system to suit your study's needs.

When it comes to analyzing and reporting results from your clinical trials' data, PVT provides a comprehensive array of services including but not limited to statistical analysis planning, data analysis, technical report writing, authoring journal manuscripts and assisting clients with regulatory guidelines.