LEVERAGING CLINICAL DATA TO STREAMLINE GLOBAL DEVELOPMENT

• What has been your biggest cost "guzzler"?
• Smart Digitization
• Effective Study Archiving Process
• Robust Analytics

BIGGEST COST "GUZZLERS"?

PAPER

• Forces many duplicate copies of the same document in multiple locations.
  • There is no centralized location where all parties can instantly access documents on demand.

• Paper requires much more manual labor to manage.

SMART DIGITIZATION

• Use a robust digital form creator.
  • Provide an efficient mechanism to collect clinical information digitally.
  • Instead of filling out monitoring visit reports on paper forms, CRAs should be able to fill them out digitally based on a template available in eClinical system.

• A robust digital form creator allows creating any type of forms that can be hosted directly in your platform.

• Benefits
  • Large savings in reviewer productivity
  • Helps eliminate multiple cluttered Excel trackers
  • Bypass paper inventory hassles
  • Avoid scanning, OCR, initial base coding
  • All of which require enormous amounts of manual labor, hence, of course, increased COSTS.

• Select an integrated platform that connects feasibility, study start up & eTMF.
  • Feasibility
    • ​​​​​​​CDA
    • Contract Dependencies
    • Investigative Site IRB Info
    • IS Contact Info
    • IS Lab Info
    • Principal Investigator Research Experience
    • Country Feasibility
  • Study Start Up
    • CDA
    • Contract (MSA)
    • IRB
    • IS Qualifications
    • Country Approvals
  • eTMF
    • IS Documents
    • Country Documents

• Ensure that the platform can share data across process steps.
  • ​​​​​​​Feasibility
  • Study Start Up
  • Trial Master File
  • Archival

EFFECTIVE STUDY ARCHIVING PROCESS

• Archive data in entity listings - example.
  • ​​​​​​​IRB Listing
    • Location
    • Meeting Schedule
    • Required Documents
  • Investigative Site Listing
    • Contact Information
    • Qualification Documents
    • IRB Information
    • Lab Information
    • Indication/Therapeutic Area
    • EDC/Subject Enrollment Data
  • Country Regulatory Listing
    • Required Documents
    • Submission Requirements
  • Patient Recruitment Listing
    • Screening Information
    • Investigative Site Information
    • Study Information

• Benefits
  • ​​​​​​​Over time it eliminates the need to get listings from 3rd party vendors for each new study.
  • It offers a set of good pre-qualified investigative sites with their proven track records from past studies.
  • It provides reliable and readily available information about essential study parties.
    • IRBs
    • Sites
    • Countries

ROBUST ANALYTICS PLATFORM

• What should you be looking for in a good analytics engine?
  • ​​​​​​​Fully integrated with systems that you use to run your clinical studies.
  • Ability to easily exchange data with external systems over standard channels such as web services.
  • Ability to run strategic aggregate reports across all past and current studies to identify time lapses between phases, activities, and processes to help with future budget and schedule planning.
  • Ability to quickly extract initial sets of information about essential parties for each new study based on study characteristics such as indication or therapeutic area or location.

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Smart Digitization

Effective Study Archiving Process

Robust Analytics Platform