Clinical Trial Software: Understanding EDC, CTMS, ePRO, RTSM, and Addressing Industry Challenges

What is a clinical trial? Clinical trial workflow and toolkit

  1. Study design and patient data capture
  2. Patient outcome collection
  3. Supply management
  4. Centralized trial management
A simplified visualization of main clinical trial systems and their functions

Study design and patient data capture using EDC

CDASH-compliant eCRF created in Oracle Health Sciences InForm
Source:
CDISC

Patient outcome collection using ePRO

Supply management using IRT and RTSM

RTSM Through The Ages — 1980s to Now
Source:
4Gclinical

Centralized trial management using CTMS

CTMS integrations needed for the centralized trial management

Clinical trial challenges

Bringing a drug to market takes from months to years
Source:
ProQR

How to solve clinical trial challenges

Adopting clinical data standards by CDISC

Automating EHR-EDC connectivity with the OneSource model

Source Data Capture from EHRs: Using Standardized Clinical Research Data
Source:
FDA

Modernizing legacy CTMS software

  1. Migrate to a new CTMS and change your entire workflow
  2. Modernize an old CTMS and keep your workflow intact

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