LEVERAGING CLINICAL DATA TO STREAMLINE GLOBAL DEVELOPMENT
Vladimir Pyagay, eClinical Solutions Engineer, TransPerfect - Trial Interactive: March 12, 2014
AGENDA
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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