Real World Data

The Real World Data (RWD) Initiative aims to collaborate with global regulatory agencies and other stakeholders to develop a framework for RWD that provides tools, methodologies, case studies, and appropriate levels of evidence to support regulatory decision-making.

Rationale

Supplementing or replacing clinical trial data with Real World Data (RWD) to inform regulatory decisions is a transformative, ambitious goal that has the potential to substantially contribute to the totality of evidence regarding the benefits and risks of drug products. Leveraging RWD can benefit patients, researchers, and regulators, among others.

Benefits

  • Enhanced evidence generation through RWD potentially leading to improved patient outcomes
  • Enhanced credibility and increased awareness of appropriate use of RWD
  • Increased confidence in acceptance of RWD for regulatory decision making

Available Solutions

For more information and to explore our solutions, visit our Initiative Solutions page.

Related Initiatives

Historical Trial Data Sharing (Controls) Solutions

The Historical Trial Data Sharing Initiative enables the sharing of historical trial data to maximize the value of clinical data collected in the control arms of clinical trials. Explore the materials below to learn more about our findings. Please note, the Historical Trial Data Sharing Initiative was formerly known as “Placebo and Standard of Care.”…

eSource Solutions

The TransCelerate eSource Initiative, begun in 2016, aimed to assist sponsors in overcoming challenges in moving towards more efficient data gathering practices to benefit patients, sites, and sponsors.  The key outcomes of this work are below. While the eSource Initiative is completed, TransCelerate remains invested in the pursuit of global implementation of eSource through our…

Digital Data Flow Solutions

TransCelerate’s Digital Data Flow (DDF) Initiative offers a mechanism to digitize clinical study components to enable interoperability and reuse, across the study lifecycle starting with study design. TransCelerate has collaborated with CDISC and other stakeholders to develop a standard data model for specifying protocol information, as well as a demonstrated way to connect disparate systems…