The ISO IDMP standards (SPOR) have been a “buzz” term lately. While the EMA already took steps in 2012 to mandate data submission and maintenance, the ISO IDMP standards looks to simplify the exchange of data among all stakeholders and improve operational efficiency by being able to use data already submitted.
While the EMA is still laying out a roadmap for implementation, CROS NT looks at the basics of the ISO IDMP standards and the business benefits.
As a data-driven CRO with full service capabilities, CROS NT offers clinical, regulatory and biometrics services. We have particular expertise in EMA regulatory issues as well as clinical data management services with a wide range of eClinical technologies.