1. 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

2. --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 established the current standard for the clinical testing of investigational drugs”….
--Kenneth I. Kaitin, PhD Tufts CSDD Director

3. Workflow for Clinical Research?

4. 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 Chunhua Weng, Yu Li, Solomon Berhe, Mary Regina Boland, Junfeng Gao, Gregory W. Hruby, Richard C. Steinman, Carlos Lopez-Jimenez, Linda Busacca, George Hripcsak

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

6. From Silos to Network Systems

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

8. 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

9. 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

10. 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

11. 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

12. 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

13. Committed to Systems Solutions
for Accountable ResearchTM