PACeR bridges the chasm that exists between corporate drug and device discovery and development research teams, academic researchers and hospital-physician and patient care networks. It fosters the translation of basic research into safe and effective product.
The current model employed by drug and device developers is to contract with CRO’s to take their developmental products to market. This strategy is flawed, especially for drug development as demonstrated by the extremely high rates of failure in clinical trial.
Why do companies turn their assets over to a CRO when results from studies that these organizations manage are so dismal? CRO’s argue that corporate development teams are the cause of the failure. Teams design trials that can’t be executed. Patient populations meeting inclusion and exclusion criteria don’t exist in the real-world. Constant protocol amendments, inappropriate clinical end-point measures and a host of other excuses are posited.
The reality is that CRO’s have no better understanding of trial design, existing patient populations or any of the other excuses for failure than corporate teams have.
CRO’s, for the most part do not “own” or control clinical sites where research is conducted. “Experts” within the CRO have no better understanding of the current standards-of-care than the corporate teams. Principal Investigators contracted by the CRO are independent contractors who do not have direct access to the majority of patient study subjects needed for a project. The management of quality, errors in data collection, timeliness of scheduled reporting and a host of other deficiencies that are a result of P.I. study management independence are equally at fault for study and product failure in clinical trial.
PACeR’s Disease Research Networks (DRN) Create Direct Corporate Connections
PACeR connects corporate scientific discovery, product development, safety and Value-based teams DIRECTLY with established Academic Research Laboratories, Hospital and Ambulatory Clinical Sites, Principal Investigators, Practicing Physicians and Patient Populations.
PACeR DRN’s are hospital and physician membership driven and are dedicated to providing collaborative research sites and basic research and practicing clinical experts to empower safer, faster and less expensive cures for our patients.
Powered by our extensive set of cloud-based tools and Clinical Research Social Networks, corporate teams have direct access to Global PACeR sites for: Collaborative Basic Medical Research, Translation from bench-to-clinic, Modeling and Authoring of Study Protocols and Patient Populations, Identifying specific study inclusion subjects in real-time for recruitment, Electronic subject education, Informed Consenting and Enrollment, Selection and Management of Hospital and Investigators, Remote-site Management including: IRB oversight; Financial Modeling, Site Payment and Study Accounting; Point-of-Care Data Entry and Data Cleaning, Study Project Risk-based Management, Adaptive Study Adjustment, Study Execution and Study Close.
PACeR Disease Networks encompass large geographic areas. Unlike the CRO failed P.I. focused approach to the conduct of a study, PACeR engages state and country-wide networks of practicing physicians and hospitals across its cloud-based platform and identifies and refers subjects. For example, PACeR-NY’s network encompasses over 200 hospitals and 18,000 physicians and 20 million potential study subjects. PACeR-Arabia accesses over 30 million potential study subjects. As important, PACeR-Arabia provides unique study populations for clinical research as a result of large-scale autosomal recessive consanguinity.
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