Transparency and Disclosure

Mitigating Risk and Ensuring Compliance

As the issue of transparency and disclosure (T&D) of clinical trial information has grown in importance, so has the recognition that sharing clinical trial information is a key step toward increasing trust between the public and the industry. More importantly, increased transparency regarding data about ongoing research could spur new products or therapeutic approaches, widen the participation of needed subjects, and potentially avoid unnecessary trials.

Synchrogenix Transparency and Disclosure Services

As external visibility increases, so must vigilance. Recognizing that T&D is inherently connected to the entire regulatory submission process and communication plan, we advise sponsors on potential areas of risk and how to embed and document compliance throughout the full drug development process. Synchrogenix provides services and technology to achieve regulatory compliance and effective participant engagement, including anonymized clinical documents, plain language summaries, and protocol registration and disclosure of study results.

ClinGenuity Redaction Management Service (CRMS)

A key concern in disclosing clinical trial data is protecting patient and other confidential information contained within those documents. The Synchrogenix CRMS solution is the only artificial intelligence (AI)-enabled redaction solution to automatically identify and redact protected personal data (PPD) and company confidential information (CCI) with more than 99% accuracy. CRMS supports redacting and de-identifying datasets in clinical study reports, patient narratives, patient data listings, and submission documents, to enable publishing of clinical study information publicly. The AI-powered solution is built on proven natural language processing and recognition; it is fully compliant with EMA Policy 70, Policy 43, and TransCelerate requirements.

Plain Language Communications for Clinical Trial Participants

According to the Institute of Medicine, nearly half of American adults have difficulty understanding and acting upon health information. This challenge is global and impacts recruiting and retaining clinical trial participants. Synchrogenix, in partnership with the Center for Information and Study on Clinical Research Participation (CISCRP), offers plain language communications services, including informed consent, protocol, and clinical trial (lay) results summaries in both written paper format for dissemination to trial sites and electronic (online) format via our online portal, MyTrialsHub.com (coming soon).

Clinical Trial Disclosure

Synchrogenix provides services to accurately and efficiently achieve sponsor compliance on ClinicalTrials.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.

Flow of Information and Mitigating Risk

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