Building A Community of Trust to Transform Medicines Development Greg Koski, PhD, MD President and Chief Executive Officer Alliance for Clinical Research Excellence and Safety

--Kenneth I. Kaitin, PhD Tufts CSDD Director “The drug development model has not fundamentally changed in more than 50 years, when the Kefauver-Harris Amendments of 1962 established the current standard for the clinical testing of investigational drugs”…. --Kenneth I. Kaitin, PhD Tufts CSDD Director

Workflow for Clinical Research?

Integrating Clinical Research and Practice An Integrated Model for Patient Care and Clinical Trials (IMPACT) to support clinical research visit scheduling workflow for future learning health systems. Journal of Biomedical Informatics, Volume 46, Issue 4, Pages 642-652 Chunhua Weng, Yu Li, Solomon Berhe, Mary Regina Boland, Junfeng Gao, Gregory W. Hruby, Richard C. Steinman, Carlos Lopez-Jimenez, Linda Busacca, George Hripcsak

Quick, more data! Personal Health and Biological Information (including Genomics) Clinical Trials and Trial-Generated Adverse Reaction Data Monitoring and Oversight Data

From Silos to Network Systems

The Power of Data Standards, Sharing and Aggregation & Analytics EHR/ Biological EDC/ CTMS Monitoring/ Audit Standards

Fundamental Elements of an Enterprise System Global Network of Accredited Sites and Professional Clinical Research Workforce Standardized Policies and Operational Procedures Shared Information Infrastructure and Risk Management System

Sharing, Security and Standards The value proposition for sharing data must be positive! Users can share information only if it is interchangeable Users will share information only if they are confident it will be used safely and wisely! Digital credentials Authentication Identity Management Access Control and Security Non-repudiation Digital Signatures

Industry Sponsors Site Management Organizations Ethics Review Boards Pharmaceuticals Biotechnology Medical Devices Healthcare Organizations Contract Research Organizations Global Dynamic Accreditation Process Site Management Organizations Electronic Health Data Patient Demographics Universal Collaborative Interface Cloud-Based Enterprise Data Vault Secure Data Aggregation and Interchange API Integrated Technology Applications Intelligent Analytic Engines Global Site Network Smart Monitoring Study Sites Standards Information Systems EDC Personnel Site Director Clinical Data Operational Data Smart Financial Engine Facilities CTMS Investigator(s) Administration and Finance Risk Monitors Study Coordinator(s) Metadata Library Information Technology Operations Dashboard Data Services Real-Time Pharmaco- vigilance Informatics Specialist(s) Compliance Monitor Quality Management Data Manager(s) Safety Data Financial Data Patient Enrollment Manager Operations Manager(s) Research Integrity Nurses and Technicians Patient Engagement Logistics Manager Smart Auditing Federated Trust Framework Identity Management Secure Digital Transactions eCommerce Quality Enterprise Management Supply Chain Providers Regulatory Oversight Agencies Ethics Review Boards Integrated Logistics All rights reserved, Alliance for Clinical Research Excellence and Safety, 2016

Challenges in “Trust-land” Multiple users, multiple platforms Single sign-on Regulatory variation Privacy laws Proprietary information Federated cloud storage Rights and privileges authorization Monitoring and auditing Encryption and security Redundancy and resiliency

Credential Service Provider Identity Management / SSO Flow CSP1 CSP 2 Trust Broker Derived System Credential Provisioning Request (Role or Org Based) Provisioning Approval SSO My Apps / Core Apps CSP3 CSPn

Committed to Systems Solutions for Accountable ResearchTM