A Streamlined Approach to Policy 70

The European Medical Agency’s (EMA’s) regulation Policy 70 requires sponsors to anonymize all Marketing Authorisation Applications (MAAs) submitted as of January 1, 2015, and provide them to the EMA for public release through a web portal.  The process of anonymization requires that patient and study administrator personal protected data (PPD) be removed or altered so that the public cannot connect the private information with actual individuals.  The EMA also allows sponsors to remove company confidential information (CCI) under some very specific guidelines.  Additionally, sponsors must provide two supporting documents: a justification table listing and explaining the CCI proposed for removal and an anonymization report outlining the methodology for anonymization of PPD.

Review and redaction of sensitive information from regulatory documents is a tedious and time-consuming process. Yet, drug development teams must perform these tasks quickly and accurately. Conventional processes are ill-equipped to manage this effort. They are slow, plagued with version control issues, and fail to accurately track and report changes. Transparency and disclosure policies such as EMA Policy 70 make having an efficient process even more critical.

Synchrogenix’s industry-leading, artificial intelligence (AI)-enabled redaction solution provides anonymized clinical trial documents in support of Policy 70 rules. PleaseTech’s newest version of their collaborative document review software, PleaseReview, enables users to review and apply redactions. In partnership with Synchrogenix’s AI technology that automatically applies contextual rule-based redactions, a new release of PleaseReview will allow sponsors to review documents in a real-time, collaborative, and controlled environment.

In this webinar, David Cornwell, Founder and CEO of PleaseTech, and Lora Killian, Synchrogenix Director of Transparency and Disclosure, reviewed the streamlined process that will be created as a result of this partnership.