03.19.15
Algorithme Pharma, an Altasciences company, is now a member of the Clinical Data Interchanges Standards Consortium (CDISC), a non-profit organization harmonizing clinical data and streamlining research processes, from protocol through analysis and reporting, to facilitate the collection of high quality research data.
A recent FDA guidance indicates that all submissions for studies started after December 2016 will require CDISC compliance for submission. Algorithme’s CDISC membership and Registered Solution Provider certification aims to enhance the harmonization efforts.
“As a CDISC Gold member, Algorithme Pharma can further collaborate with global leaders and contribute toward the development and release of new standards. We now have the ability to play a key role in the evolution of CDISC standards. Our sponsors can rest assured that we are implementing all standards as soon as they are released,” said Petra Hillebrand, vice president, Integrated Services and Process Optimization.
A recent FDA guidance indicates that all submissions for studies started after December 2016 will require CDISC compliance for submission. Algorithme’s CDISC membership and Registered Solution Provider certification aims to enhance the harmonization efforts.
“As a CDISC Gold member, Algorithme Pharma can further collaborate with global leaders and contribute toward the development and release of new standards. We now have the ability to play a key role in the evolution of CDISC standards. Our sponsors can rest assured that we are implementing all standards as soon as they are released,” said Petra Hillebrand, vice president, Integrated Services and Process Optimization.