How Certara and TrialAssure Partner to Deliver Faster, Compliant Anonymization for Global Sponsors

The following case study on Certara anonymization is based on real work conducted between TrialAssure and one of its trusted partners to build stronger anonymization and redaction processes and tools. Together, they cut manual effort out of that work, extended the tooling behind it, and ran it as one team.

Problem

Certara’s Clinical Disclosure team needed to streamline and enhance their document anonymization 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 anonymization 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. That form is a regulatory deliverable in its own right: under the EMA’s clinical data publication policy, sponsors releasing anonymized clinical documents must also describe the methods they applied and the residual risk of re-identification.

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 TrialAssure 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 anonymization report form template, TrialAssure also introduced a report functionality that extracted necessary information from the system and automatically populated key fields in the anonymization report form. This reduced the manual effort required to populate the anonymization 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. Clinical documents rarely present the same identifier the same way twice, which is where a fixed rule set runs out.

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. Feature requests and urgent document-specific issues went to the same group, so answers came back without a handoff between vendor and customer.

“TrialAssure has been an essential partner in helping us deliver high-quality, compliant anonymization and redaction services to our clients. Their ability to adapt quickly to our needs and provide responsive support has streamlined our processes, reduced review cycles, and strengthened the transparency services we offer sponsors worldwide.”

Evan Richardson, Senior Director, Regulatory Operations & Clinical Disclosure, Certara

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.