Providing solutions that keep the pain out of compliance

Pharmaceutical companies and other sponsors of clinical trials are under increased pressures to disclose data and documents in accordance with regulations and requirements that include the European Medicines Agency (EMA) Policy 0070 and Health Canada Public Release of Clinical Information (PRCI). As the demand for increased transparency and disclosure continues to grow, so does the need for more advanced anonymization and redaction solutions to meet changing regulations and the needs of patients, study participants, and their caregivers.

As the leading technology and services provider in clinical trial transparency and disclosure, Synchrogenix, Certara’s regulatory sciences division, provides technology-enabled advanced anonymization and redaction services for posting regulatory documents and clinical trial data in the public domain. These services include compliance assessment, consulting and project leadership, and remediation planning.

Synchrogenix has been at the forefront of the transparency movement since the inception of EMA Policy 43 including the support of proactive report disclosure by large pharma before regulations were introduced. Synchrogenix was the first to provide an artificial intelligence (AI)-enabled redaction technology solution with built in patient privacy algorithms to the marketplace.

“Thank you so much for providing all the documents required for the XXX NDS PRCI project, including the proposed redaction documents for personal information and confidential business information, anonymization report, and CBI control sheet.”

– Regulatory Director, Global biotechnology company

Data anonymization and redaction management powered by artificial intelligence

The Synchrogenix Redaction Management Service artificial intelligence (AI)-powered anonymization and 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 they require. In addition, our experts assist sponsors with the authoring of anonymization reports.

Features of our anonymization process include:

  • Validated and 21 CFR Part 11 compliant system
  • Powered by natural language processing (NLP)
  • Risk based questionnaire to set individual risk thresholds
  • Multi-system generated risk assessment for optimal balance between risk and utility
  • Reusable templates
  • Systematized approach to quality control review
  • Customizable publishing formats

Using the Synchrogenix Redaction Management Service, we have redacted over 15 million report pages to date and worked with 22+ sponsors in 2020.

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Technology paired with in-house statisticians

Recognizing the importance of optimizing the utility of your clinical data while still maintaining patient privacy, we employ our global team of in-house statisticians to assure your compliance with the evolving regulatory requirements for quantitative risk and advanced anonymization of trial data.

From clear-cut to more challenging thresholds and determinations based on population size and disease, we work with your team to come up with the optimal approach.

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Strategic consulting services

Our transparency and disclosure experts address sponsor-specific initiatives and risk tolerance while maintaining compliance according to established agency guidelines and industry watchdog measures.

  • Experienced consulting and project leadership to ensure that transparency requirements are met in the most optimal manner
  • Preparation of remediation plans and creation of future robust processes, including policies, Standard Operating Procedures, and Work Instructions
  • Routine and expedited clinical trial registration and disclosure of results, including redaction of clinical trial protocols and statistical analysis plans

As key opinion leaders, our anonymization and redaction experts speak regularly at major transparency and disclosure events worldwide.

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CBI/CCI identification

Preparing anonymized and redacted reports for regulatory agency submissions that remove Company Business Information (CBI) for Health Canada and Company Confidential Information (CCI) for EMA presents a major challenge for sponsors.

The ability to identify the intellectual property that sponsors want to protect versus what is already in the public domain is an extensive activity that calls on finite legal and regulatory resources within sponsor organizations. We address this for our sponsors by offering a unique consulting team that has expertise with both regulatory and legal backgrounds.

Our team of experts are able to:

  • Drive the identification process with sponsors’ teams and take the lead in developing the criteria for a specific submission
  • Manage the process for you, including identification, leaving a simplified review/approval step
  • Utilize our system that will annotate the reports appropriately and develop an automated proposed control sheet

Our process has saved sponsors a great deal of frustration. Additionally, sponsors have seen a reduction in agency review of their CBI/CCI.

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Our Experts
Mari Welke Director, Safety and Innovation

Mari brings nearly 25 years of industry experience, from both sponsor and service provider perspectives, spanning clinical development, project management, process improvement initiatives, medical writing, safety analysis, clinical trial disclosure, team management, and systems development. She works with clients and internal colleagues to bring future solutions to safety documents and the transparency and disclosure space.

Nirpal Singh Virdee Global Head of Transparency & Disclosure

Nirpal comes with over 18 years of Life Sciences experience. He is a subject matter expert in the Clinical Development, Regulatory Landscape, Transparency and Disclosure space. He is considered an industry thought leader, having globally presented at conferences. He has sat on industry advisory panels. At Synchrogenix , Nirpal is accountable for business development, client management and consulting for technology enabled services.

Trevor Standish Associate Director, Product Management

Trevor brings vast experience in developing product strategy, roadmaps, and requirements with cross-functional teams to launch successful software products. He has spent the last decade creating and managing disruptive technologies in finance, marketing, and pharma. His focus on collaboration between customer and company aligns incentives delivering successful results.

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