Your trusted partner for accelerating drug development through innovative clinical trial design and delivery.
We advance frontier mental health and neurological therapies through the clinical development pipeline.
Our Services
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Clinical Research Support
From Phase I to III, we can support drug manufacturers at every point of their clinical development journey, right through to market approval.
Utilising our in-house expertise and a strong network of academic partners across the UK and Europe, we draw on our up-to-date knowledge in the field to guide innovative approaches to clinical trial design.
Our team has an in-depth understanding of the complex factors and challenges that psychedelic-assisted therapies present to clinical trial design.
We provide strategic guidance on the optimal research methodologies, including advice on drug tapering and selection of outcome measures to maximise trial impact and high-value data output. Approaching clinical trial design with the patient experience in mind, we maintain a strong ethical and scientific stance throughout to ensure rapid regulatory approval.
And Submissions
Through our experience in trial design and delivery, we have gained a strong reputation among regulators as a leading, innovative organisation working in clinical research on psychedelics.
As a trusted partner of the MHRA and with a strong knowledge of the latest schemes available (including ILAP and EAMS), we can help identify the right process for your product that will provide the fastest route to market.
Our experienced team can advise confidently on de-risking clinical trial applications, and guide your application through the complex regulatory and ethics submissions and approval process.
Treatment Centres
Clerkenwell Health is home to the first psychedelic therapy clinic in Central London’s medical district, nearby Harley Street.
The site has been custom-developed by our in-house team of clinical trial managers, scientists, and clinicians and designed around the specific needs of psychedelic-assisted therapy.
Our facility will facilitate the speed of site access, avoiding the lengthy bureaucratic processes common in university and hospital-based sites to hasten timelines and patient access.
We understand the importance of ‘set and setting’ in psychedelic-assisted therapy. We have intricately designed our treatment rooms and therapy protocols to guarantee the quality of the therapeutic experience.
Our handpicked pool of psychiatrists and therapists have a wealth of experience and training in psychedelic-assisted therapy and seek to deliver the highest standard of treatment to your trial participants.
Training, recruitment and monitoring
Clerkenwell Health has developed a market-leading approach to recruiting, training and monitoring therapists in a clinical trial context.
We have the ability to ‘white label’ therapy manuals for clients, and tailor our therapist training to their needs.
We have developed processes to monitor and continually improve therapists’ practice and adherence to manuals.
Our Leadership
Dr Emilio Arbe
Chief Medical Officer
Clare Knight
Senior Clinical Trials Manager
Tom McDonald
Chief Executive Officer
Dr Henry Fisher
Chief Scientific Officer
Sam Lewis
Chief Financial Officer
“We could not be happier with the work done so far by the Clerkenwell Health team! This partnership has already proven to be invaluable to Octarine, allowing us to make significant strides in our R&D plan”
– Nick Milne, Co-founder & CSO of Octarine
‘Clerkenwell Health’s understanding of the unique requirements of psychedelic-assisted therapies and the literature surrounding them allows us to dramatically accelerate our clinical development plans.'
– Dr Neil Maresky, CEO of Psyence Group
Want to get in touch with us? Let’s talk ⟶
Announcements
There is a significant & increasingly unmet need for effective mental health treatments, and psychedelic medicines offer a new solution.
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1
MENTAL ILLNESSES PREVALENCE IS INCREASING WITH A CORRESPONDING RISE IN SPEND
» Untreated mental health problems account for 13% of the total global burden of disease
» By 2030, mental health problems will be the leading cause of mortality and morbidity Global spend to exceed $16 trillion between 2010-2030 (direct and indirect costs)
2
EXISTING DRUGS ARE WIDELY DEEMED AS HAVING POOR EFFICACY AND MAJOR SIDE EFFECTS
» Widely accepted that existing mental health drugs are ineffective at treating the root causes of mental health conditions
» Less than 30% of patients report positive response rate to SSRIs (antidepressants)
3
EARLY-STAGE CLINICAL TRIALS SHOW EFFICACY OF PSYCHEDELIC THERAPIES ACROSS MANY CONDITIONS
» Dramatic shift in attitudes toward psychedelics have accelerated the amount of drug development and research in the field.
» FDA have twice granted psilocybin ‘breakthrough therapy’ status - only granted to highly promising treatments
4
INCREASING INVESTMENT INTO MENTAL HEALTH AND PSYCHEDELICS STARTUPS
» Global investment in mental health startups surged from £120m in 2014 to £580m in 2019 (Octopus Ventures)
» In September 2020 British psilocybin drug development company, Compass Pathways completed a $146.6 million IPO on the NASDAQ.
