Electronic Review Systems

Electronic Review Systems

• 1.
  Deciding on anelectronic review system Dale Cooke Digitas Health
• 2.
  • Faster approvaltimes • Complete audit trail • Lower agency costs • Improved compliance 2 e-System Benefits
• 3.
  • If thewrong system is implemented or the system isn’t implemented well, the costs are severe: • Cost-overruns and delays during implementation • Frustrated users • Confused agency partners • Compliance risks • Increased cost for reviewing and approving materials (both internally and from agency partners) 3 e-System Drawbacks
• 4.
  Relatively Few Established Players Aprimo VeevaVault Zinc Ahead Documentum Next Docs
• 5.
  • Agency access •One log-in per agency is preferred • Automatic agenda creation • Opens job codes well before submitting projects • Audit reports • Auto-generates certain communications (approval to use, expiration notices, etc.) • Clean user interface • Maintains a library of references • Ability to integrate with other systems (procurement, print production, Digital Assessment Management (DAM)) • How are updates rolled out? 5 Key Features
• 6.
  Key Features (cont’d) •Mobile access (iPad & iPhone) • Immediate accessibility of meeting markup • Ability to link associated projects (e.g., an outer envelope, cover letter, and brochure) • Automatically track expiration dates for annual review and generate renewal reminders • Support all standard web browsers and updates • Allow for integration with FDA Gateway • Accommodate multiple regions and approval processes • Deal with co-promote/joint venture partners • Understand the hosting environment and whether it can accommodate volume demands
• 7.
  Reference Handling • Maintaina library of acceptable references • New references should be vetted by medical reviewer prior to system addition – Ensure this isn’t too time consuming – Avoids duplicate references • Link references to projects using them • Accommodate multiple links to and from the same claim and/or reference • Core claims documentation • Be wary of systems that link too much (weigh the costs and benefits of traceability)
• 8.
  Keys to aSuccessful Implementation • Involve the right people in the implementation • Train at the right time (Goldilocks rule, not too soon, not too late) • Understand customization vs. configuration distinction – Avoid customization • Establish a team of champions with local/regional/departmental representation
• 9.
  Dale Cooke VP/Group Director,Regulatory Review Dale Cooke is the head of the regulatory department for Digitas Health. He has worked with more than 30 pharmaceutical, biotech, and medical device clients and with Medical-Legal-Regulatory committees around the world from offices in Philadelphia, New York, San Francisco, Boston, and London. Dale advises clients on FDA enforcement actions and provides recommendations for compliance with FDA regulations, with a focus on issues involving the Internet and emerging technology. His insights have been featured in the Wall Street Journal’s Health blog, The Pink Sheet, MedAdNews, PharmExec, and others. Dale is a member of the Regulatory Affairs Professionals Society (RAPS) and the Food and Drug Law Institute (FDLI). Dale is the author of Effective Review and Approval of Digital Promotional Tactics, which is part of the FDLI primer series. He is regularly invited to speak at industry conferences on topics including FDA enforcement trends, best practices for review processes, global review practices, and pharmaceutical involvement in social media. Dale earned his B.A. in Philosophy from Southern Methodist University and an M.A. in Analytical Philosophy from the University of Arizona and studied Epidemiology and Biostatistics at Drexel University’s School of Public Health.