Health Sciences Network Real-time Access To Healthcare Data for R&D Through Post Market Research
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1 Health Sciences Network Real-time Access To Healthcare Data for R&D Through Post Market Research Joel Haspel Director Health Sciences 21, October, 2014
2 Safe Harbor statement The following is intended to outline our general product direction. It is intended for information purposes only, and may not be incorporated into any contract. It is not a commitment to deliver any material, code, or functionality, and should not be relied upon in making purchasing decisions. The development, release, and timing of any features or functionality described for Oracle s products remains at the sole discretion of Oracle.
3 Alerts Studies Health Sciences Network (HSN) A collaborative network Real Time Data De-identified Self Service Data Healthcare Provider/Pharmacy participants Protocols Protocols Life Sciences Sponsor Participants Data Management Service De-identified Self-Service Protocol Validator & Patient Recruiter Services Study/Site Feasibility, Patient Recruitment, and Grant collaboration Safety Pharmacovigilance, CER, and more to follow Feasibility results in seconds Instantly links patients to study, site, and investigator No buying and selling of data Strong security, protects institutional IP and brings governance to collaboration Gives every patient the same access to the latest in research Network Participants Include:
4 Health Sciences Network (HSN) Opportunities for bio-pharma / med device industries Access to EHR through HSN Protocol Validator and Patient Recruiter enables R&D Epidemiology studies Feasibility assessment and minimize amendments Early site / investigator identification Trial recruitment Predictability, Quality, Speed Access high quality samples for companion diagnostics research Safety Pharmacovigilance monitoring Post market Comparative analytics Competitive insights
5 Sponsor Feasibility on HSN Leverage the data and link into provider side processes Access to near real-time data No more purchasing static data or having to build massive databases for feasibility Brings power of the data directly into the hands of study teams (sponsor and IIT) Easy to use user interfaces for inclusion/exclusion criteria builder and get instant results Save time and money by not building multiple custom databases or waiting for feasibility query results HSN brings healthcare institutional level relationships to sponsors Institutional relationship versus PI centric relationship translates for faster response times from sites HC/Pharmacy institutions incentivized to assist in decisions on patient distribution and multi-site studies Save time and money by completing site feasibility early in the protocol criteria design phase High quality de-identified electronic medical records data Updated on a nightly basis with 5+ years of longitudinal data on patients Complex protocols will require access large qualities of high quality clinical data Save time and money by minimizing protocol amendments and building more accurate protocols
6 Patient Recruitment on HSN Leverage the data and link into provider side processes Information driven decision making for clinical trial operations Brings power of the data directly and instant results into the hands of clinical trial operations teams HC/Pharmacies optimize patient identification and out-reach for clinical trial enrollment Complete site and investigator selection early in study design phase Minimize site start-up timelines Save time and money by selecting sites/pis based on population metrics,not guestimates HSN driven model for system-wide enrollment reach Institutional relationship versus PI centric relationship helps to reach more patients across provider network HSN alerts clinical trial coordinators on new candidate/qualified candidate visit to any of its hospitals, clinics or pharmacies HC/Pharmacy institutions have access to integrated data and technology to optimize site performance Save time and money by increasing site staff efficiency, effectiveness and productivity Integrated workflows with pharmacies and healthcare providers Ability for sponsors to share protocol criteria with pharmacies and HC providers to assist with site and investigator decisions Monitoring study progress in real time Save time and money by increased visibility throughout enrollment period and complete enrollment targets
7 Transition to a system-wide active trial method ACTIVE TRIAL METHOD USING HSN TRADITIONAL METHOD PASSIVE TRIAL Patients must find investigators Advertisements Chance visit to the investigator PATIENT ALERT Clinical trial coordinators at provider alerted to potential candidate visit Provider side trusted broker re-identifies candidates and alerts physician about benefits of study Future: Investigating team directly contacts potential candidates RECRUITMENT Physician and patient discuss study, if patient consents; patient is tagged in HSN; patient gets screening Physician refers patient to investigator, if required Patient is enrolled into study
8 Thank you!
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