Emerging Biotech Selects Synchrogenix, a Certara Company as Transparency & Disclosure Provider
In early 2020, an emerging global biotechnology company was in need of anonymization and redaction services for upcoming expected Health Canada approvals. They engaged Synchrogenix, Certara’s Regulatory Sciences division, to prepare the company’s first ever redaction filings in 2021. In the interim, due to internal growth, the company found itself needing additional transparency & disclosure services, including protocol registrations and clinical trial results postings. The company also required the authoring of plain language summaries.
With this being the company’s first redaction project, Synchrogenix provided expertise and guidance to team members on redaction requirements. Synchrogenix facilitated redaction rule definitions; provided assistance in planning for their Health Canada Process Initiation Meeting; and guided the client internal team on identification and review of patient sensitive and company business confidential information.
Thank you so much for providing all the documents required for the XXX NDS PRCI project, including the proposed redaction documents for PI and CBI, anonymization report and CBI control sheet.
Regulatory Director Global biotechnology company
Health Canada’s objective is to make anonymized clinical information in drug submissions and medical device applications publicly available for non-commercial purposes following the completion of Health Canada’s regulatory review process, while adhering to Canada’s Privacy Act.