The European Medical Agency’s (EMA’s) regulation Policy 70 requires sponsors to anonymize all Marketing Authorisation Applications (MAAs) submitted as of 2015 年 1 月 1 日, 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.
Join our webinar on November 10, where David Cornwell, Founder and CEO of PleaseTech, and Lora Killian, Synchrogenix Director of Transparency and Disclosure, will review the streamlined process that will be created as a result of this partnership.
David Cornwell founded PleaseTech in 2002. Over the last 14 years, he has developed PleaseTech and its flagship product, PleaseReview, into the world’s leading collaborative document review and co-authoring solution. David is a business visionary and veteran of the technology market providing thought leadership in the area of document collaboration. David is a science and engineering graduate of Imperial College, London and holds a Master of Business Administration degree from the University of Bath.
Lora Killian, Director of Transparency and Disclosure, has over 12 years of pharmaceutical and business operations experience. She is responsible for the development and oversight of Synchrogenix’s entire suite of transparency services which includes anonymization, clinical trial disclosure, and lay language summary development. Ms. Killian has played an integral role consulting with sponsors in the development of company-specific transparency policies to address the latest wave of regulation arising out of the EU and the US.