Study Participant Engagement, Transparency, and Disclosure Services
Synchrogenix provides expertise, services, and technology, not only to meet transparency and disclosure requirements, but also as a complement to our commitment to enhance engagement of study participants and the general public in drug development. Synchrogenix produces anonymized and redacted datasets and clinical documents; authors Informed Consent Forms (ICFs), plain language study design and results summaries, and other plain language documentation; and supports protocol registration and disclosure of study results. Synchrogenix addresses sponsor-specific initiatives and risk tolerance while maintaining compliance according to established policy guidelines and industry watchdog measures.
Clinical Trial Postings and Results Disclosure
The demand for transparency and disclosure of clinical trial data continues to grow. Disclosing clinical trial information and creating transparency of data are key steps toward increasing engagement, trust, and data utility. These, in turn, are expected to spur new products and therapeutic approaches, and enable sponsors to avoid unnecessary trials.
Synchrogenix provides the following services:
- Accurate and efficient assessment of current sponsor compliance with posting 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.