Mitigating risk and ensuring compliance across all publically disclosed text and data
The issue of transparency and disclosure of clinical trial data growing in importance over the past few years. Disclosing clinical trial information and creating transparency around the data are key steps toward increasing trust between the public and the industry. Increased transparency regarding data about ongoing research could spur new products or therapeutic approaches and potentially avoid unnecessary trials.
Synchrogenix Transparency and Disclosure Services
Synchrogenix provides services, technology, and expertise to meet transparency and disclosure requirements. Synchrogenix produces anonymized clinical documents, lay summaries, as well as supports protocol registration and disclosure of study results. These documents are created according to established policy guidelines and customized to address sponsor-specific business rules to address compliance and consistency requirements. Our unique artificial intelligence (AI)-enabled technology is the most effective and efficient approach to mitigate risk for meeting data transparency requirements. The technology is effective across our entire suite of services and can be employed to meet each company’s business objectives.
Policies 43 and 70 – ClinGenuity Redaction Management Service (CRMS)
We offer the only AI-enabled redaction solution in the marketplace to automatically identify and redact protected personal data (PPD) and company confidential information (CCI) with more than 99% accuracy.
- The Synchrogenix CRMS solution is fully compliant with the EMA Policy 43 and TransCelerate.
- The AI-powered solution is built on authoritative and proven natural language processing and recognition. As a result, our solution automatically and accurately identifies and marks for redaction-sensitive information across thousands of pages and millions of words of documentation at accuracy levels that manual options simply cannot match.
We work closely with our clients to
- Define criteria around several aspects of the overall process.
- Review transparency guidance along with company-confidentiality policies to determine what information is to be retained versus what is to be redacted.
- Configure the system (based on established requirements) providing an end-to-end solution.
- Allow for the AI engine to create an automated output.
- Include legacy study reports, new study reports, and submission documents.
- Work with scanned PDF’s, converted PDF’s, and Microsoft Office documents.
Synchrogenix in partnership with the Center for Information and Study on Clinical Research Participation (CISCRP), provides clinical trial participants with high-quality, written summaries of their trial’s results. Lay summaries provide patients and others with a summary of the complex scientific explanation of the clinical research project.
Lay summaries support PhRMA and EFPIA transparency commitments and pending European Union requirements.
Synchrogenix automatically prepares draft lay summary text and images using its AI, providing quality control to ensure data and message accuracy.
Clinical trial disclosure
Synchrogenix provides services to accurately and efficiently assess current sponsor compliance on ClinTrials.gov and EudraCT systems, establish a remediation plan, establish future processes and complete clinical trial registrations and disclosures.
Our uniquely trained writers and editors lead and operationalize the registration and disclosure component of clinical trial data to meet transparency requirements.