Initiatives & Solutions

Initiative

Toxicology & Background Data Control Sharing

This Initiative will enable participating companies to make data-driven decisions on compound progression based on an increased understanding of on-target and off-target toxicity.

The scope of the Initiative is to design, develop, and maintain a centralized data lake capable of storing, visualizing, analyzing, and linking toxicology and background control data, both in structured and unstructured data formats.

Initiative

Common Templates for Nonclinical Studies

The Common Templates for Nonclinical Studies Initiative is pursuing, with input from sponsors, CROs and other stakeholders, the development of common templates for preclinical studies to improve efficiencies for investigators, sites, CROs, sponsors and regulators. Common templates will help minimize cost, errors, reduce burden for sites and CROs, and improve operational efficiencies during the interpretation and execution of studies. The initiative is focused on developing publicly available documents for preclinical study protocols and study reports that are intended to be used by CRO partners and sponsors.

Initiative

SEND Implementation for Cross-Study Analysis

In collaboration with the FDA through a public-private partnership, the SEND Implementation for Cross-Study Analysis Initiative is pursuing the development of proposed solutions for the implementation and use of CDISC SEND data packages with the aim of facilitating cross-study analysis of clinical trials. Open-source guidance on SEND as applied to study analysis, intended for use by CROs, regulators, and sponsors, has the potential to contribute to a broader knowledge base across early-stage R&D and support faster, more improved decision-making.