(Laval, Québec, Canada, March 19, 2015) – Algorithme Pharma, an Altasciences company, is now a proud 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, including the use of electronic health records 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 Pharma’s gold CDISC membership and Registered Solution Provider certification further enhances the capabilities of this established full service early stage clinical contract research organization in delivering quality solutions to their sponsors, and demonstrates the company’s commitment to staying ahead of industry needs.
With well over a decade of experience, Algorithme Pharma’s team of Biostatisticians, SAS Programmers and Data Managers provide high quality data with a personalized approach. Algorithme Pharma partners with sponsors on a wide range of therapeutic areas, from Alzheimer, Bipolar Disorder and Cardiovascular, to Diabetes, Erectile Dysfunction, Gastroenterology and Hepatology, and several others.
Over the last five years, the team has completed over 1,000 early and late stage studies: Single/Multiple Ascending Dose [SAD/MAD], Drug-Drug Interaction [DDI], Pharmacokinetics (PK), Pharmacodynamics (PD), Clinical Endpoints, Efficacy, Health Economics and Post Marketing.
“As a CDISC Gold member, Algorithme Phama 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”, stated Petra Hillebrand, Vice President, Integrated Services and Process Optimization.
Altasciences, owned by Kilmer Capital Partners, owns Algorithme Pharma, Algorithme Pharma USA and Vince & Associates Clinical Research. All organizations operate with a common mission, to provide the best quality early stage clinical development services to an international customer base of pharmaceutical, biotechnology and generic companies with a focus on customer service.
CDISC is a 501(c)(3) global non-profit charitable organization, with over 300 supporting member organizations from across the clinical research and healthcare arenas. Through the efforts of volunteers around the globe, CDISC catalyzes productive collaboration to develop industry-wide data standards enabling the harmonization of clinical data and streamlining research processes from protocol through analysis and reporting, including the use of electronic health records to facilitate the collection of high quality research data. The CDISC standards and innovations can significantly decrease the time and cost of medical research and improve quality, thus contributing to the faster development of safer and more effective medical products and a learning healthcare system. The CDISC Vision is to inform patient care and safety through higher quality medical research.
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