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Pharmaceutical and biotechnology companies are under increasing pressure to improve the speed of drug development. The figures are well known; the average cost to develop a drug to the post approval stage is reported by the Tufts Centre to be $890 million.
The introduction of technology has been one way in which companies have tried to improve their clinical trial processes. However, the move to replace paper with eClinical technologies has brought new challenges, the challenges that you face every day.
Assero are committed to helping pharmaceutical companies in the adoption of data interchange standards, focusing on the Clincial Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM). Assero develop tools to assist companies comply with the standard and also help deploy the model in conjunction with the other CDISC models as part of the true eClinical trial. The company is a member of CDISC and actively supports the standards body in its activities, both in Europe and globally.
Assero Limited
A CDISC Registered Solutions Provider
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Recent Events:
Standards Shock Therapy: Monitoring the State of CDISC and HL7 for Clinical Research and Regulatory Submissions
DIA 45th Annual Meeting. San Diego, CA. June 21-25, 2009.
Convergence of Data and Document Standards: Where Does CDISC Meet eCTD?
DIA 45th Annual Meeting. San Diego, CA. June 21-25, 2009.
CDISC Pilots
DIA 45th Annual Meeting. San Diego, CA. June 21-25, 2009.
Update on the FDA's Electronic Case Report Form Submission Operational Data Model (ODM) Pilot
DIA 45th Annual Meeting. San Diego, CA. June 21-25, 2009.
The CDISC Technical Roadmap
CDISC European Interchange. Budapest, Hungary. April 22-23, 2009.
Published Articles:
CDISC data standards:
reaching out to a global
audience
World Pharma Network. Summer 2008. Read it here.
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