Enhance engagement. Meet requirements. Maintain compliance.

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 increasing engagement, trust, and data utility. These, in turn, are expected to spur new products and therapeutic indications, which can lead to a competitive advantage with Clinical Investigators.

Certara Regulatory Science, also known as Synchrogenix, provides expertise and technology-enabled services, not only to meet transparency and disclosure requirements, but also to enhance the engagement of study participants, their caregivers and healthcare professionals, and the general public. We address your specific initiatives and risk tolerance while maintaining compliance according to established policy, guidelines, and industry watchdog measures.

As key opinion leaders, Synchrogenix’s transparency and disclosure experts speak regularly at major transparency and disclosure events worldwide.

Data anonymization and redaction management powered by artificial intelligence

Our ClinGenuity Redaction Management Service (CRMS) artificial intelligence (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 anonymized reports.

We have processed over 6500 reports (13+ million pages) and completed 65+ European Medicines Agency (EMA) Policy 0070 submissions. Our redaction process supports EMA, Food and Drug Administration (FDA), and Health Canada redaction and anonymization requirements.

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Accurate and efficient clinical trial postings

Using a proven methodology, we’ve supported sponsors with thousands of trial postings to global disclosure databases.

  • Reliable and comprehensive assessment of your current compliance with postings on ClinicalTrials.gov, EudraCT, and other applicable worldwide registries
  • Experienced consulting and project leadership across process components 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
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200+ plain language summaries

Engaging the patient is key. Writing for patients and the general public is vastly different from writing for regulatory authorities or clinicians. Although not yet a regulatory requirement for the FDA or EMA, it is expected that by 2021, the EMA will require all clinical trial sponsors to prepare a summary of the results of every clinical trial written in language understandable to the general public.

Having authored 200+ plain language summaries to date, our medical writers produce plain language summaries in the voice and advocacy of the patients’ interests, effectively and efficiently.

Plain language summaries ensure that study participants are informed about study results and that they understand the value of their contribution to science and public health.

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Engage with Patients via PODIUM

As a complement to our commitment to enhance engagement of patients, caregivers, clinicians, and patient advocates in drug development, we’ve created PODIUM. Using our secure PODIUM platform, sponsors can receive valuable responses throughout the clinical trial process from patient groups within specified therapeutic areas.

  • Inform protocol feasibility by engaging with patients in the study planning/development stage
  • Provide feedback on documents intended for patient use, including informed consent forms and patient summaries of EU Risk Management Plan
  • Allow patient groups an opportunity to provide comments and assess readability of the plain language summary
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Featured 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.

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