Using Cloud-Based Technology in Clinical Trials - The Technology and Procedures are both Important

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What is Cloud Computing?
Essentials for Cloud-Based eClinical Applications
Contracting with Cloud-Based Technologies
Embrace eClinical Cloud-Based Features in Your Procedures

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Using Cloud-Based Technology in Clinical Trials - The Technology and Procedures are both Important

  1. 1. Using Cloud-Based Technologies in Clinical Trials: The Technology and Procedures are both Important October 31, 2013
  2. 2. Introduction Craig Wigginton Chief Technology Officer Craig brings over 20 years of product development, software engineering and architecture experience, with recent success in population health management, healthcare supply chain management and telecommunications services. Craig spent seven years leading the Technology and Service Delivery organizations at Health Integrated as the Chief Operating Officer and Chief Technology Officer. Previously, he was Chief Technology Officer at Neoforma where he led the development of the NeoConnect™ platform responsible for revolutionizing supply chain connectivity for acute care hospitals. Prior to Neoforma, he was one of the founding engineers of Pharos Technologies and held various technical leadership roles with Centillion Data Systems, Ameritech (AT&T) and E-Span. Confidential – 2
  3. 3. Introduction Niki Kutac Product Manager Niki has over 10 years’ of eClinical technology and Data Management experience, at the vendor, CRO and biotech levels. Prior to joining DATATRAK, Niki held positions at Nuron Biotech, Pharm-Olam International, and ClickFind, Inc. Confidential – 3
  4. 4. Agenda • • • • What is Cloud Computing? Essentials for Cloud-Based eClinical Applications Contracting with Cloud-Based Technologies Embrace eClinical Cloud-Based Features in Your Procedures Confidential – 4
  5. 5. What is Cloud Computing? Confidential – 5
  6. 6. Cloud Computing is Everywhere Today Confidential – 6
  7. 7. Technical Definition of Cloud-Computing ► “Cloud computing is a model for enabling ubiquitous, convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, and services) that can be rapidly provisioned and released with minimal management effort or service provider interaction.” ---National Institute of Standards and Technology (NIST) U.S Department of Commerce Confidential – 7
  8. 8. Simple Definition of Cloud-Computing ► “The practice of using a network of remote servers hosted on the Internet to store, manage, and process data, rather than a local server or a personal computer.” ---Oxford Dictionary Confidential – 8
  9. 9. Cloud Jargon Jumble ► ► Customers are often confused by what is really cloud Cloud is • Elasticity • Scalability • On-Demand • Dynamic • Confidential – 9 Provisioning Managed Upgrades
  10. 10. Essential Cloud Components ► ► ► On-demand self-service • Acquire computing capabilities as needed, without human interaction or support Available Everywhere • Access is provided through standard mechanisms any time, anywhere on any device – Mobile phones, tablets, laptops and workstations Dynamic Computing Resources • Confidential – 10 Computing resources are pooled to serve multiple consumers using a multi-tenant model, with different physical and virtual resources dynamically assigned and reassigned according to consumer demand. – Examples of resources include storage, processing, memory, and network bandwidth.
  11. 11. Essential Cloud Components ► Rapid elasticity/Scalability • Resources may be quickly provisioned and released when no longer needed ► Measured service • • Confidential – 11 Service may leverage metering capability Usage can be monitored, controlled and reported, providing high transparency
  12. 12. Essentials for Cloud-Based eClinical Applications ► Enterprise Class Security • Support for current security standards • ► – PCI DSS, HIPAA, HITECH and SOC 2 Self-service administration Disaster Recovery & Business Continuity • Ability to maintain availability to serve your business • Redundant sites, hardware and networks • Verified business continuity plan Confidential – 12
  13. 13. Essentials for Cloud-Based eClinical Applications ► Validation • Ensure consistent on-going performance, security and integrity of stored and managed data ► Availability & Uptime • Confidential – 13 Redundancy to provide users with limited down-time – Designed to be upgraded while online – No down-time for mid-study changes
  14. 14. Key Ingredient – Service Level Agreement Service Level Agreement (SLA) allows you to manage the cloud-based vendor appropriately Measure what matters - Availability (99%) - Support Services - Response Times - Service Level Credits Confidential – 14
  15. 15. Cloud-Based Technologies open a whole new world for Clinical Trial Management Confidential – 15
  16. 16. With Cloud-Based eClinical Applications Contracting with CROs & Sites takes on a SLA like model Confidential – 16
  17. 17. Site Contracting • Negotiate enforceable expectations for clinical data entry into eClinical application – i.e. Data Entry within 48 hours of visit • Payments based on data quality (no queries or open issues) Confidential – 17
  18. 18. CRO Contracting • Negotiate enforceable expectations for: – Operational & trial data entry into eClinical application – Data Cleaning Activities Confidential – 18
  19. 19. CRO Contracting • Move away from time based unit of measurements to activity/task based measurement • Define the responsibilities and task associated with the cloud and who is responsible Confidential – 19
  20. 20. Important Functionality for Cloud-Based eClinical Applications • Reports • Standard & Ad-hoc Reports • Status Reports on Data Entry & Cleaning • Ability to see average times to task • Time between Visit Date & Entry (EDC) • Time from Query response to Query Close (EDC) • Time between data received & data entered (CTMS, eTMF, Safety, Labs) Confidential – 20
  21. 21. Averages Report Confidential – 21
  22. 22. Important Functionality for Cloud-Based eClinical Applications • Record Archival • Ensure any application provides industry and regulatory required archival records • Minimum Integrations • By selecting a unified (single) database that does not require integrations (pushing/pulling) of data provides streamline process Confidential – 22
  23. 23. WITH A CLOUD-BASED ECLINICAL APPLICATION EMBRACE THE PROCEDURAL CHANGES Confidential – 23
  24. 24. Embrace eClinical Cloud-Based Features in Your Procedures • Real-Time System Responses – Data Driven Inventory Re-supply Triggers – Notifications for Serious Adverse Events – Data Trends – Quality Issues • Greater Study Control – Turn Site Enrollment Off/On – Views/Permissions Confidential – 24
  25. 25. Embrace eClinical Cloud-Based Features in Your Procedures • Real-Time Study Management – Study Dashboards – Reports – Remote Data Review & Monitoring • Access the Data from Any Device – Mobile, Tablet, Laptop or Workstation • Flexibility of Contracted Resources – With Cloud-Based Technologies the proximity of contracted resources is no longer an issue Confidential – 25
  26. 26. In Summary make sure your vendor provides all the essential components of an eClinical Cloud-Based Application and have the proper procedures in place to support the application. Confidential – 26
  27. 27. Confidential – 27

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