May 15, 2023 — London, UK: Drug developers will now be able to find the most suitable regulatory environment to run psychedelic clinical trials and have access to a transatlantic network of specialist clinical research sites and services through a new partnership launched today (15th May 2023).
Clerkenwell Health, who opened Europe’s first commercial psychedelic clinical trials facility in London last year, have partnered with Cognitive Research Corporation, a full-service contract research organization founded in 2006 that specialises in Central Nervous System (CNS) product development for the pharmaceutical, nutraceutical, biotechnology, and medical device companies, to accelerate psychedelic research between US-UK.
The combined offering is nimble, with services tailored to client needs. The partners look to solve challenges in this research field through collaboration rather than traditional client-vendor relationships. In addition to in-house sites, the combined offering has access to a network of sites with the right experience and expertise to recruit and deliver consistently.
In addition to its CRO services, Cognitive Research Corporation advances the value by leveraging their proprietary neuropsychological assessment and state-of-the-art simulation technologies for the rapid assessment of deficits or changes in attention, memory, information processing, and executive function to further support the developing market. (CogScreen, MiniSIM)
Cognitive Research Corporation’s CEO, C.G. Gillooly said “We are excited about this collaboration in this rapidly emerging segment of our market. Over the decades that we have been helping clients navigate the challenges associated with developing new therapies to address mental health conditions we have seen the psychedelic segment evolve from concept to now a well-funded reality. There remains much work to be done in terms of executing proper clinical trials to confirm efficacy and therapeutic benefit. This partnership will help both us and Clerkenwell achieve that objective.”
George McBride, Clerkenwell Health’s Chief Commercial Officer said “I am a firm believer that long-term success is rooted in collaboration. The traditional client-vendor relationship in clinical research will be beaten by niche and nimble operators who challenge the status quo, put their clients’ needs first and seek creative solutions to complex issues. I’m excited to see what this partnership of expertise and experience can bring to the psychedelic research field.”
The news comes as more North American biotech companies look to London as a key location to run clinical trials due to its fast-track approvals and welcoming clinical and preclinical infrastructure. Clerkenwell Health have been engaging the UK regulatory authorities on behalf of clients for over a year with success in accelerating clinical development plans and receiving regulatory approval for clients conducting trials with classic and new psychedelic compounds for mental health and CNS conditions.
Both Clerkenwell Health and CRC team will be presenting at the 3rd Annual Psychedelic Therapeutics and Drug Development Conference in San Francisco in 15-16 May. Clerkenwell Health’s CEO Tom McDonald is hosting a panel on the unique challenges of running psychedelics-assisted therapy trials in different jurisdictions, with different regulators. Joining him are Mindset Pharma CEO James Lanthier and Vice President of PharmAla BioTech Harpreet Kaur. In addition, Gary Kay, Ph.D. Cognitive Research Corporation Co-Founder & Chief Scientific Officer will be the featured speaker presenting Driving Safety following Administration of Psychedelics – a guidance for conducting large trials with psychedelics.
About Clerkenwell Health
Clerkenwell Health is a specialist clinical research organisation, focused on supporting clients with the design and delivery of psychedelic-assisted therapy trials. They facilitate psychedelic research at scale through commercial centres of excellence which allow organisations to run clinical trials, co-develop drugs and be at the forefront of clinical innovation.
The team brings together decades of international regulatory affairs, clinical development strategy, clinical operations, and market access expertise. They support clients by identifying suitable indications, engaging regulators, designing clinically sound and scientifically robust study protocols, and delivering trials through their own facilities and those of their wide partnership network. More information about Clerkenwell Health can be found on their website.
Cognitive Research Corporation’s mission is to support innovative companies developing new medicines and therapies to improve mental health and neurological disorders. As a leading neuroscience clinical research organization (CRO) and cognitive assessment technology company, CRC works with sponsors, specialized clinical trial sites, and CNS experts to bring new drugs through rigorous testing to support FDA submissions and eventual market introduction. For more information, visit www.cogres.com. To read the full press release, please visit EIN Presswire.