Digital Data Flow

This initiative aims to move the drug development process from a current state of manual, study start-up asset creation (i.e. Case Report Forms, Procedure Manuals, Statistical Analysis Plans, and Schedule of Activities) to a future state of fully-automated, dynamic, study start-up readiness via an open-sourced, vendor-agnostic technical solution that will reduce cycle times and improve data quality for sponsors, third-party providers, sites and regulators.

Rationale

Currently, there exists an average lag time of four months between protocol completion and study start. Furthermore, third-party conversion of data to SDTM lengthens cycle time and presents limits for traceability and re-use. Finally, working in a document-based environment results in significant manual duplication of effort.

This initiative aims to move the drug development process from a current state of manual, study start-up asset creation (i.e. Case Report Forms, Procedure Manuals, Statistical Analysis Plans and Schedule of Activities) to a future state of fully-automated, dynamic, study start-up readiness via an open-sourced, vendor-agnostic technical solution that will reduce cycle times and improve data quality for sponsors, third-party providers, sites and regulators.

Benefits

Near-term:

  • Accelerate study start-up asset readiness
  • Minimize bottlenecks between processes and systems
  • Eliminate need for reconciling across study start-up assets, improving consistency and quality
  • Execute automatic propagation of changes and amendments required post study start-up across assets
  • Encourage and facilitate a vendor agnostic solution

Long-term:

  • Take advantage of innovative technologies to automate and enhance creation of study start-up assets
  • Expand connectivity beyond study start-up related systems
  • Enable platform trial design and set-up

Available Solutions

Available assets include:

  • Solution Framework & Conceptual Design
  • Executive Summary
  • Appendix describing a technology-enabled business process for defining a clinical study design supported by a Study Builder platform

Similar Initiatives

Clinical Content & Reuse

What is Clinical Content & Reuse (CC&R) The Clinical Content & Reuse (CC&R) Initiative, formerly known as Common Protocol Template (CPT), aims to enhance clinical trial processes by developing common content for reuse across clinical trial documents in the Clinical Template Suite (CTS). The CTS works towards having electronic, machine-readable documents and improving overall end-to-end efficiencies.

Clinical Data Standards

Clinical data are reported by individual trials in various ways which may cause a labor intensive process to gain data insights. The Clinical Data Standards Initiative, in collaboration with CDISC (Clinical Data Interchange Standards Consortium), C-Path (Critical Path Institute), NCI- EVS (National Cancer Institute – Enterprise Vocabulary Service) and FDA as part of the CFAST (Coalition For Accelerating Standards and Therapies), aims to develop industry-wide Data Standards in priority Therapeutic Areas (TAs) to support the exchange and submission of clinical research and metadata, while improving patient safety and clinical trial outcomes.

eSource

The eSource Initiative seeks to assist TransCelerate Member Companies, and ultimately other trial sponsors, in overcoming real and perceived challenges to influence more efficient data gathering practices to benefit patients, sites and sponsors.