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Initiative

Common Templates for Nonclinical Studies Initiative (CTNS)

The CTNS Initiative is focused on, with input from sponsors, CROs and other stakeholders, developing publicly available documents for preclinical study protocols and study reports that are intended to be used by CRO partners and sponsors. Efforts are focused on improving efficiencies for investigators, sites, CROs, sponsors and regulators by helping to minimize cost, errors, reduce burden for sites and CROs, and improve operational efficiencies during the interpretation and execution of studies.

Initiative

Enabling Translational Safety

90% of drugs fail overall in clinical development and 30% of drug failures are due to unmanageable toxicity or side effects. Industry practice designed to anticipate these observations are limited.​

TransCelerate is uniquely positioned to advance a Translational Safety solution that drives value for key stakeholders by improving the use of historical data to increase patient safety, reduce cycle times, promote sustainability and advance science. ​

The desired outcome is to bring therapies to patients faster. Achieved through improved decision making around compound toxicity and focused use of resources.

Initiative

SEND Implementation for Cross-Study Analysis Initiative (SEND)

In collaboration with the FDA through a public-private partnership, the SEND 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 preclinical 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.

Initiative

Toxicology & Background Control Data Sharing Initiative (TDS)

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