2023 Pre-Conference Workshop II
Sunday, May 14, 2023
Psychedelics & Clinical Trials: Site Feasibility and Audit Preparedness
⇒ Learn about licensing requirements for clinical sites.
⇒ Learn about agreements with Contract Research Organizations, who will be running your clinical trial.
⇒ Be introduced to an analysis framework to help trial sponsors consider various clinical trial sites and determine which sites are feasible.
⇒ Identify issues that may come up in an audit and could shut down your clinical trial.
⇒ Identify potential fraud and abuse risks around clinical trials reimbursement.
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 and viable go-to-market strategy.
Our team has deep industry expertise in a broad range of therapeutic areas and indications including Mental Health, CNS/Neurology, Ophthalmology, Sleep Medicine, Gastroenterology, Dermatology, Oncology, Rare Diseases, and Chronic and Neuropathic Pain conditions and more. In addition, we can support decentralized trials, digital health products and advise on the use of AI in drug discovery.
At Knowde Group we understand the business of research and combining innovation and extensive experience, we take a progressive approach to consulting services, clinical research, commercial outsourcing, and data intelligence. We help clients connect the dots between their needs and our offering that uses a strong collaborative approach and vast connected network of global expert advisors, preidentified research sites, vendors and partners.
Similar to the early days of the medical cannabis movement, psychedelic drugs such as MDMA, psilocybin, LSD, ketamine and DMT are emerging in a complex and difficult legal and regulatory environment that can frustrate efforts to develop new therapies. Our team guides researchers, manufacturers, investors, clinicians and other participants around and through the myriad obstacles that result from the patchwork of state and federal laws regulating Schedule I controlled substances, including the Controlled Substances Act (CSA), Money Laundering Control Act (MLCA), various criminal statutes that cover the sale and consumption of psychedelics, and various state legal and regulatory regimes.
Our team is multidisciplinary by nature and integrates subject-matter authorities who can drill down into relevant issues at every phase of research, development, commercialization and medical practice. We assist entrepreneurs and investors in forming ventures and developing governance structures best suited for operation in the psychedelic industry. Once established, clients turn to our regulatory and finance lawyers to assist with operationalizing and funding the enterprise.