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Certara Adopts TrialAssure ANONYMIZE Solution to Speed Life Science Industry Need to Meet Regulatory Requirements for Data Sharing

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Certara (Nasdaq: CERT) has licensed TrialAssure's ANONYMIZE software to enhance anonymization of clinical data. This collaboration allows Certara's regulatory science division, Synchrogenix, to offer tailored anonymization services as a SaaS model to over 1,650 global biopharmaceutical clients. The ANONYMIZE tool enables full configurability to sponsor specifications, leveraging machine learning for efficient data processing. This partnership aims to strengthen compliance with increasing regulatory demands for data transparency in clinical trials.

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  • Licensing of ANONYMIZE software enhances data anonymization capabilities.
  • Expands Certara's service offerings with tech-enabled anonymization.
  • Strengthens compliance with regulatory transparency requirements.
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TrialAssure® – a leading, global software company advancing clinical trial disclosure, data sharing, and transparency – has announced today that Certara (Nasdaq: CERT) – the global leader in biosimulation – has licensed TrialAssure’s ANONYMIZE software to anonymize clinical data.

TrialAssure’s ANONYMIZE for Data provides a cutting-edge anonymization application for datasets that allows clinical trial sponsors to anonymize all structured clinical trial data, including datasets and tables, and is entirely configurable to sponsor specifications and architected to take advantage of machine learning capabilities.

Through this collaboration, Certara’s regulatory science division, Synchrogenix, will utilize TrialAssure ANONYMIZE in a software-as-a-service (SaaS) model to provide a tech-enabled Anonymization service for their client roster of more than 1,650 global biopharmaceutical and biotech companies across 61 countries.

“We are pleased to partner with TrialAssure to build on our strengths as the leading technology and services provider in clinical trial disclosure and transparency,” Mari Welke, Director, Safety and Innovation, Synchrogenix. “Certara will add TrialAssure’s anonymization technologies to our suite of tech-enabled services, including ClinGenuity™ for redaction and PODIUM™ for patient engagement to provide clients with a full range of options to meet regulatory requirements.”

In recent years, pharmaceutical companies and other sponsors of clinical trials have been under increased pressure to disclose data and documents from regulations and requirements that include the European Medicines Agency (EMA) Policy 0070 and Health Canada Public Release of Clinical Information (PRCI).

“Certara has a long history of partnering with best-in-class technology solutions, and our collaboration is an important endorsement to TrialAssure’s commitment in strong disclosure and transparency solutions that are built to evolve with the future of the pharmaceutical industry,” said Mohamad Zahreddine, Chief Information Officer, TrialAssure, and member of the Forbes Technology Council. “Through this collaboration, Certara will be able to provide even faster solutions for its robust client base.”

To learn how to meet and exceed data sharing requirements with Certara, visit: https://www.certara.com/regulatory-science/transparency-disclosure/

About TrialAssure

TrialAssure is a leading, global clinical trial disclosure, data sharing, and transparency software company with unmatched experience in helping navigate complex regulatory compliance challenges. TrialAssure provides fast, affordable, and informed technology and service solutions to help clinical trial sponsors meet clinical trial registration and results reporting, document and data anonymization, patient engagement, and compliance reporting goals. Established in 2009, TrialAssure regularly adapts to ever-changing clinical trial disclosure and data transparency requirements and was recently named Data Solution of the Year—Healthcare in the Data Breakthrough Awards. For more information, visit: www.trialassure.com or follow TrialAssure on LinkedIn.

About Certara

Certara accelerates medicines using biosimulation software and technology to transform traditional drug discovery and development. Its clients include more than 1,650 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 61 countries. For more information, visit www.certara.com.

FAQ

What is the purpose of Certara licensing TrialAssure's ANONYMIZE software?

The licensing allows Certara to enhance its anonymization capabilities for clinical data, providing a tech-enabled service for clients.

How does TrialAssure's ANONYMIZE software support Certara's clients?

The software supports Certara's clients by allowing them to configure the anonymization of clinical trial data to meet various regulatory requirements.

What companies benefit from Certara's new anonymization service?

Over 1,650 global biopharmaceutical and biotech companies across 61 countries can utilize Certara's new anonymization services.

When did Certara announce the licensing of ANONYMIZE software?

Certara announced the licensing of ANONYMIZE software on March 16, 2021.

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