Within a year, aligned and simultaneous document and data submissions will be live for Centralised Procedures managed by EMA, and pharma companies will need to take advantage of the intervening time to make sure they have the system capabilities to meet the requirements.
CARA was configured to the original IDMP ISO standards and, thanks to the way the platform is built, additional changes required for the EMA Implementation Guideline v2 have been simply a matter of rapid configuration. This is now well underway following the recent publication of the latest guidance, and will be ready delivery by the end of this month.
“Many software vendors have been slow to provide something tangible for their clients, preventing them from progressing their system plans to be ready to submit compliant data as part of their marketing authorisation submissions once this becomes the expectation, starting next year,” says James Kelleher, CEO of Generis. “We’re different. We are ready to help customers deliver on their SPOR / IDMP requirements as part of the CARA Life Science platform.”
Generis is a UK-headquartered developer of world-class Content and Regulatory Information Management technology for regulated industries globally.
Eight of the top 10 global life sciences companies rely on Generis’ flagship Intelligent Content Services platform, CARA™ for critical document and information management, including AbbVie, AstraZeneca, Biogen, Gilead, Bayer, Pfizer, and Merck KGaA.
Today Generis serves more than half a million users worldwide, across use cases ranging from RIM, Regulatory / R&D and Safety use cases to Clinical, Non-clinical, Quality GxP, CMC, Pharmacovigilance, Medical Information / Medical Affairs applications and more. More at generiscorp.com
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