Meet and exceed transparency and disclosure requirements with one team, one integrated solution.

The demand for transparency and disclosure of clinical trial data continues to grow.  Disclosing clinical trial information and creating transparency of data are key to growing engagement, trust, and data utility. These, in turn, are expected to spur new products and therapeutic approaches, and enable you to avoid unnecessary trials.

Certara’s Synchrogenix team provides expertise, services, and technology, not only to meet transparency and disclosure requirements, but also to enhance engagement of study participants and the general public.  We address your specific initiatives and risk tolerance while maintaining compliance according to established policy guidelines and industry watchdog measures.

 

Redaction management powered by artificial intelligence

Certara’s ClinGenuity Redaction Management Service (CRMS) is the only artificial intelligence (AI)-enabled redaction technology solution in the market. It can identify and redact sensitive information with 99% accuracy.

Our AI-powered redaction solution is supported by expert reviewers who ensure that trials with specific challenges, such as small populations or rare diseases, receive the customized approach that they require. In addition, our experts assist sponsors with the authoring of anonymization reports.

We have processed over 6500 reports and completed 65+ European Medicines Agency (EMA) Policy 0070
submissions. Our redaction process supports EMA, Food and Drug Administration (FDA), and Health Canada requirements.

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Advanced anonymization techniques

We engage in both standard and advanced anonymization techniques, such as quantitative risk assessment.

Our methodology is based on Certara’s Synchrogenix internal expertise in the implementation of probability of re-identification and K-Anonymity, adhering to Clinical Data Interchange Standards Consortium (CDISC) Data de-identification standard for Study Data Tabulation Model (SDTM).

All of the Synchrogenix Anonymization APIs are designed using the Open API Specification—implemented as Swaggerized RESTful APIs, with standard, language agnostic, machine-readable interface descriptions, callable from a browser interface through a published Uniform
Resource Identifier (URI) or programmatically consumed by other APIs.

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Accurate and efficient clinical trial postings

Certara’s Synchrogenix team offers a wide range of solutions to ensure that your clinical trial postings are accurate and efficiently managed.

  • Reliable and comprehensive assessment of your current compliance with postings on ClinicalTrials.gov, EudraCT, and other applicable worldwide registries
  • Preparation of remediation plans, updates or completion of entries, and creation of future robust processes, including Standard Operating Procedures and Work Instructions
  • Routine clinical trial registration and disclosure of results, including redaction of clinical trial protocols and statistical analysis plans
  • Experienced consulting and project leadership across process components to ensure that transparency requirements are met in the most optimal manner
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