eTMF and Site Archiving: Lessons Learned

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Agenda

• Background
• Why is drug assessment necessary
• How is endpoint adjudication managed today
• How can we make it more efficient

Background

• Focus of many pharmaceutical companies today is creating treatments for chronic conditions and diseases.
  • This shift results in:
    • Increase in development times and cost
    • Requirement of long term data to assess benefits and risks
    • Endpoint driven studies

Why is drug assessment necessary?

• Allow regulatory authorities to monitor effect of the intervention on an ongoing basis
  • ensure drug or device safety
  • more sound and effective clinical trials

Who generally assesses these endpoints?

• Clinical Endpoint Committees (CEC)
  • Unbiased reviewers

How is endpoint adjudication managed today?

• Source Data Collection
• Send items to Clinical Project team
• Report endpoint
• Identify documents that need translation and submit to vendor
• Issue and resolve query for missing or incomplete items
• Compile endpoint package
• Submit to CEC
• Review package
• Issue and resolve query
• Complete adjudication

How can we make it more efficient? Go Paperless

Drawbacks to Paper

• No centralized location for packages
• Documents need to be shipped to and from several parties including: site, CRO, Translations team, Adjudicators
• Slow work flow, frequent duplication
• Adjudication results recorded on paper CRF need to be shipped to CRO and or Sponsor to identify patterns

Electronic Enhancements

• One seamless portal, easy communication and sharing of documentation
• Documents move from one party to the next in a single electronic platform
• Decrease processing time and avoid duplicates with electronic identifiers
• Adjudication completed on same electronic platform and results are visible immediately

SPONSOR

• Visibility into all cycle times
• Customized reports
• Real-time data on key deliverables

CROs

• Faster package assembly
• Online query
• Online coding

ADJUDICATORS

• Real-time access to endpoint
• E-adjudication card built in
• E-CRF card built in

10% Decrease in CEC Adjudication Time

30% Decrease in Endpoint and Package Processing Time by CRO

75% Reduction in Translation Turnaround Time

90% Decrease in Shipping Costs

Additional benefits of Electronic Adjudication

• Allows Sponsor to design their own unique workflow
• Immediate reconciliation with EDC
• Easy access for international teams
• Data allows for power calculations, periodic safety reviews by Data Safety Monitoring Boards, sample-size re-estimation and other interim analyses, overall results for efficacy and safety analyses