a boutique clinical research service provider

Phase V Technologies, Inc. specializes in providing services supporting information systems and technologies involving direct-from-patient data collection, analysis and interpretation of health care and clinical research data for outcomes research and management. Since 1987, Phase V has been providing its clients in the pharmaceutical, health technology and health care industries with solutions for evaluating the impact of new therapies, devices and disease management programs.

Patient-Focused Drug Development

Phase V has been providing its clients in the pharmaceutical, health technology and health care industries with solutions for evaluating the impact of new therapies, devices and disease management programs using the Phase V® Health Outcomes Information System (PVOIS), a proprietary platform, customized to the requirements of the study design. This system has evolved over the past 35 years from a paper-based questionnaire and unconnected-device platform to a connected, highly integrated web-based technology service platform, offering visualizations and artificial intelligence aids to Phase V technicians and clinical site staff for dealing with the complexities of “big data” outcomes amassed through the use of continuous and frequently measured physiological sensors, biotechnology and ecological momentary assessments in addition to the standard clinic-based assessments.

Over a quarter of a century before the FDA’s “Patient-Focused Drug Development”  became a critical goal in drug and device approvals, Phase V had trademarked the term “Phase V®” to describe patient-centered outcomes as the “fifth phase of therapeutic testing” in the drug and device industries.

With Phase V’s focus beyond laboratory and clinical assessment,  Phase V emphasizes the importance of demonstrating the effectiveness of therapies and medical interventions in real world settings from the patient’s perspective.

To achieve the real-world delivery of patient data, since 2004, Phase V has used device enabled technologies to incorporate direct-from-patient data to the clinical research studies for new drugs and devices during pre-marketing and post-marketing studies.

Our Services

We provide a range of services like questionnaire development, remote patient data collection and monitoring, statistical analysis and reporting.

35 Years of Scientific Innovation in Direct-from-Patient Assessments

Phase V Technologies was built on a strong foundation of scientific innovation in clinical trial research, promoting new methods for therapeutic drug and device development.

35 Years of Regulatory of Patient Reported Outcomes Assessment

Phase V Technologies was the first Contract Research Organization to promote the use of patient-reported outcomes including the assessment of quality of life and treatment satisfaction in pivotal Phase 3 clinical tirals.

35 Years of Advancing Technological Development

Phase V Technologies has excelled in advancing technology in the  measurement, data collection, intensively longitudinal big data analytics and statistical analyses as part of its Phase V® Outcomes Information System for clinical trials research.

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799-P: Gender Differences in Diabetes Distress Comparing Dapagliflozin plus Saxagliptin to Glimepiride When Added to Metformin in Poorly Controlled Type 2 Diabetes

MARCIA A. TESTA and DONALD C. SIMONSON, Boston, MA Gender Differences in Diabetes Distress Comparing Dapagliflozin plus Saxagliptin to Glimepiride When Added to.

810-P: Patient-reported outcomes in T2D patients inadequately controlled by metformin are more favorable for dapagliflozin plus saxagliptin vs. insulin glargine.


1520-P:  Impact of Patient-Centered Factors on Comparative Effectiveness of Initial Therapies in Treatment-Naïve T2D

MARCIA A. TESTA, ALEXANDER TURCHIN, MAXWELL SU, DONALD C. SIMONSON, Boston, MA Impact of Patient-Centered Factors on Comparative.

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