The following case study is based on real work conducted between TrialAssure and one of its trusted partners, Certara, to build stronger anonymisation and redaction processes and tools.

Problem

Certara’s Clinical Disclosure team needed to streamline and enhance their document anonymisation and redaction processes to better serve their global client base. Their vision was to achieve process efficiencies in these tedious and often error-prone processes, while maintaining high quality deliverables, remain compliant with regulations, and significantly reduce queries from regulatory agency reviewers.

At the same time, Certara wanted a partner that was responsive to urgent document-specific challenges to comply with tight deadlines and meet their customers’ expectations. With evolving requirements, endless document variations, and a new anonymisation report form template, Certara sought a partner that could deliver more mature tools and faster support turnaround times while producing high-quality and regulatory compliant documents.

Solution

As Certara’s exclusive partner for anonymization and redaction, TrialAssure worked closely with their team to address these challenges and improve efficiency. TrialAssure enhanced ANONYMIZE® with multiple features, that supported Certara’s vision. One of the features soon to be implemented is a new output format that removed extraneous technical data, presenting only the information necessary for regulatory reviewers. This reduced confusion during the regulatory review process and unnecessary back-and-forth between Certara and the regulators. To align with the updated anonymisation report form template, TrialAssure also introduced a report functionality that extracted necessary information from the system and automatically populated key fields in the anonymisation report form. This reduced the manual effort required to populate the anonymisation report, supported the accuracy of the information presented, and ensured compliance with the regulatory guidance. Additionally, TrialAssure implemented a flexible rule method, giving Certara more advanced capabilities to identify sensitive information when standard approaches were not sufficient.

Throughout the partnership, TrialAssure worked with Certara as one team that included solution architects, developers, business analysts, and technical support. This allowed Certara to maintain tight timelines for their clients and regulatory agencies.

Results

This ongoing collaboration between Certara and TrialAssure has resulted in faster, more efficient anonymization processes that reduce manual effort to directly benefit Certara’s biopharmaceutical and biotech sponsors. The streamlined outputs and compliant reporting have reduced unnecessary back-and-forth with regulatory agencies, accelerating review timelines, and improving sponsor satisfaction. TrialAssure’s responsive support and AI-powered solutions have allowed Certara to meet its tight deadlines, satisfy its customers, and comply with regulatory agency requirements. This ultimately improved quality and delivery.

Together, Certara and TrialAssure have anonymized over 850,000 pages across more than 250 projects, reinforcing their shared commitment to advancing clinical trial transparency and helping medicines reach patients sooner.

For questions regarding this case study or a demo of ANONYMIZE, connect with us here.