Knowde Group Announces Successful Site Support Post Health Canada Non-Compliance Inspection

Knowde Group Announces Successful Site Support Post Health Canada Non-Compliance Inspection




Knowde Group Announces Successful Site Support Post Health Canada Non-Compliance Inspection

TORONTO–(BUSINESS WIRE)–Knowde Group (“Knowde”) provides clinical trial management services and strategic advisory focused on the conduct of phase I-III trials globally, including investigator initiated and registry trials. We are excited to announce the successful completion of our regulatory and site support post Health Canada inspection for Remedy Institute, which is a research site conducting phase 2 MDMA clinical trials in Canada. Health Canada deemed the Corrective and Preventative actions post Health Canada Inspection acceptable to resume conducting clinical trials.

As a result of the Health Canada Inspection and findings, The Remedy Institute did undergo a complete revision of their Quality Management Systems and staff training to address Health Canada’s GCP Inspection findings. Although inspections can be challenging to experience, it provides an opportunity for sites to improve compliance and study conduct,” said Jaspreet Grewal, CEO of Knowde Group.

The Knowde Group team manages psychedelic clinical trials, including site selection and feasibility, to help ensure the success of psychedelic clinical trials. There is currently a challenge finding sites globally to conduct clinical trials using psychedelic-assisted psychotherapy, and we support sponsors with site assessment and feasibility as this is one of the most critical decisions impacting a sponsor’s clinical trial program. This includes but is not limited to an experienced research site, risk mitigation plan, qualified and experienced study team, track record of recruiting participants, with the appropriate set and setting for extended safety monitoring, and insured and regulated investigator(s) trained in the use of psychedelics and with the therapeutic indication.

The proper conduct of clinical trials and ensuring participant safety are paramount to the success of any clinical program. As the psychedelic industry continues to grow, we are pleased to continue to provide our clients with the tools they need to find success in their research endeavours.

Knowde Group thanks Remedy Institute for choosing our team on this project and we congratulate the study team as they commence the conduct of their psychedelic clinical trials. Consider donating to Remedy Institute to support the important work that they are doing, information on how to donate can be found on their website www.remedyinstitute.ca.

About Knowde Group

Knowde Group, Inc is a female-minority founded company providing phase I to III clinical trial management services globally with offices in Canada, the US and the United Kingdom. In addition, Knowde Group provides consulting services to support Biotech and Life Sciences companies with strategic support from preclinical advisory up to commercialization, including reimbursement strategies. Knowde Group understands the importance of funding to drive clinical trials and innovation; as such Knowde Group provides a unique offering of connecting investors to viable biotech and life science companies that have a strong go-to-market strategy.

Contacts

For further information, please contact Sabrina Ramkellawan, Knowde Group at info@knowdegroup.com