US FDA awards I-ACT for Children a grant for pediatric medicines & devices network

The US Food and Drug Administration has awarded the Institute for Advanced Clinical Trials for Children (I-ACT for Children) a grant to improve clinical trials of new drugs and devices for children. The award establishes an alliance among I-ACT for Children and PEDSnet, the James M. Anderson Center for Health Systems Excellence, Critical Path Institute and the National Capital Consortium for Pediatric Device Innovation, to work together with leading children’s institutions and health systems to address key gaps and challenges in pediatric clinical trials.Continue reading

White Paper: Innovation Challenges for Large and Small Companies

Challenges in innovation are universal in many ways. The need for user requirements identification, brainstorming/ idea generation, prototype creation, and feedback collection are staples of the design process across many industries. However, a dichotomy exists for large and small companies with respect to the challenges they face when trying to create a robust product innovation process. Continue reading

C-Path and CDISC Announce Therapeutic Area User Guide For Duchenne Muscular Dystrophy

TUCSON, Ariz., and AUSTIN, Texas – October 18, 2017 –Critical Path Institute (C-Path) and The Clinical Data Interchange Standards Consortium (CDISC) announce the open availability of a Duchenne Muscular Dystrophy Therapeutic Area User Guide (TAUG-DMD v1.0), which describes the most common clinical concepts relevant to Duchenne studies using the CDISC standard format. This format allows datasets from different sources to be compared or combined for data collection, sharing, and analyses.Continue reading