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Full Service CROTurn-Key Phase II to IV Clinical Trials

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Real World Evidence (RWE) is the clinical evidence concern-ing the usage, benefits and

risks of marketed pharmaceutical products in clinical practice. RWE is derived from an analysis of Real World Data assembled about a prod-uct’s use in the “real world”, collected outside the controls and limitations of conventional randomized clini-cal trials. The “real” safety profile of a marketed drug will be revealed by continuing safety surveillance through an extemporaneous adverse event monitoring system, and post-marketing surveillance studies. RWE can be collected from many sources including patient health records, registries and observational stud-ies, health insurance data, biobanks, physician and patient surveys. RWE is an important aspect of pharmaceutical product evolution and commercialization. Regulatory authorities, public and private pay-ers, prescribers and manufacturers demand more comprehensive infor-mation on real-world safety and ef-fectiveness of marketed pharmaceu-tical products. Real-world patient experience can be leveraged to im-prove the quality of medical care, re-duce costs and improve outcomes. It can even result in further evaluation for new indications. RWE impacts the reimbursement and utilization of new products, and early product entry in niche indications.Since 2001 Allphase Clinical Re-search Inc. a full-service CRO, has been designing, implementing and managing Phase IV post-marketing surveillance studies including non-

interventional prospective observa-tional studies, patient registries and health surveys, and retrospective chart reviews, collectively called Re-al-World Evidence (RWE) research. Allphase Clinical works closely with Alio Health Services (www.alio-health.com) to manage ICH/GCP-controlled Phase IV/RWE trials us-ing Patient Support Program (PSP) data. Alio Health Services provides phar-maceutical companies with turn-key PSP services that support patients through their treatment journey, from prescription to reimbursement to administration and adherence. Alio Health has transformed the way in which health care services are de-livered, through the use of their rev-olutionary web-based software tool called HOMETM (Health Outcomes Management Engine). The HOMETM system automates many of the pro-cesses required to manage a PSP more efficiently and more accurately.When used in conjunction with an

Allphase-managed Phase IV study that ensures the protection of per-sonal health information, additional PSP data collection elements are integrated that marry the PSP with the Phase IV study, including data collected directly from patients us-ing Patient Reported Outcomes (PRO) administered through the HOMETM system Patient Interface. The HOMETM system is a validated, 21 CFR Part 11 compliant software suite that can feed data directly into the Allphase DataInsight EDC sys-tem, thus providing a contiguous, unified database.Phase IV studies conducted in close association with a HOMETM enabled PSP leverages layers of Real World Data that are typically ignored, or only used for business intelligence and performance management KPIs. This solution also facilitates additional engagement with the physician and patient in a more holistic way.

www.allphaseclinical.com

Real World Evidence2

Jeff Smith, President & CEO, Allphase Clinical Research Inc.