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Phase IV Post-marketing Biometrics Support

Industry Vertical: Pharmaceutical

Executive Summary

Phase IV trials involve the post-launch safety surveillance and ongoing technical support of a drug following its release to the marketplace. Post-launch safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and timescale than was possible during the initial clinical trials. InfoVision assisted one of the industry leaders in finding, developing, and bringing to market new medicines and related products for persistent pain, with post-marketing studies of a multi-billion dollar blockbuster drug.

InfoVision leveraged (a) its understanding of FDA clinical trial process, its experience in data acquisition, analysis process development, data organization and biometric analysis, and (b) its expertise in advanced analytical platforms such as SAS to help our client successfully complete several post-marketing studies in several categories of target populations as part of phase IV. Our initial work subsequently led to development of additional protocols, analytical models and biometric report templates for our client, for use both in additional Phase IV studies and also in other future clinical trials.

Our Client

Our client is a privately held pharmaceutical company. Headquartered in Connecticut, USA it is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products. Together with its independent associated companies, it is dedicated to finding, developing, and bringing to market new medicines and related products that promote health and healing. The company has long been known for its pioneering research on persistent pain, a principal cause of human suffering.
Our client has led the battle against inadequate treatment of pain by developing sustained-release medications to manage pain and provide meaningful benefits for patients. Its sales, marketing, and medical education professionals provide the healthcare community with comprehensive educational materials and programs relating to pain management.

Our Client’s Need

With the introduction of the drug into the marketplace, our client needed to ramp up its ability to perform Phase IV studies, or post-marketing studies, as these are known in the industry. The post-marketing study team required, among other skills, the expertise to develop biometric protocols as part of each new study, organize various internal and external process to reflect the protocol, collect data following the commencement of a study, normalize received data, analyze it using FDA approved and other complex techniques, and develop results for subsequent interpretation by the entire team. The function also required a deep understanding of commercial solutions, especially from SAS, for analysis, charting and reporting. Finally, the client desired to leverage the intellectual property and processes for both the present drug as well its future drug launches.

How InfoVision Helped

As part of a multi-disciplinary team, InfoVision provided critical expertise and skills related to biometric protocol development, collection of data from various post-marketing studies involving pediatric patients, post-operative care and neuropathy. Further, once the study data was accumulated, it was be cleansed, normalized and analyzed using FDA mandated, and proprietary criteria. SAS Technology and tools were utilized to conduct statistical analysis, regression testing, graphing and report generation. The results were reviewed by the biometric team and others in the client organization, to organize within the safety database and to decide on next-steps, actions.

Client Benefit

InfoVision’s work
(a) Accelerated our client’s ability to complete a substantial number of post-marketing studies
(b) Assisted our client in complying with FDA and other regulatory requirements in a timely manner, and
(c) Enhanced our client’s ability to continue revenue growth from the drug.

InfoVision provides IT staffing solutions, SAS-powered information delivery, visualization & collaboration, and wireless & IP communications. Contact InfoVision for more information on our integrated value delivery model.

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