Your trusted partner for accelerating psychiatric and CNS research through innovative clinical trial design and delivery.
We design and deliver clinical trials on time and within budget, with optimised outcomes.
Clerkenwell Health is closing a critical gap in the clinical trial landscape, specialising in psychiatry and CNS—fields experiencing rapid growth and requiring expertise to deliver on time and budget. Despite this surge in research, specialised trial sites outside the US are limited. We’re on a path to becoming the European leader by building a scalable network of clinical trial sites and CRO-enabling services.
-
![]()
“Their fast site set-up, expertise and timely recruitment of patients have been evident throughout our ongoing Phase IIa study of BPL-003 for Alcohol Use Disorder and Phase IIb study of BPL-003 for Treatment Resistant Depression. We are impressed by their high standards of professionalism and commitment to delivery which have supported the progress of our clinical research.”
-
![]()
“Strong therapists and strong patient recruitment. We at Transcend Therapeutics would be very grateful if you are able to get your second research facility on-line as soon as possible to support our ongoing IMPACT-1 trial. Following the performance of your first site, having a second (and even more) would be a big help to accelerate the delivery of our trial.”
-
![]()
“Clerkenwell represents an excellent partner to push forward our regulatory efforts. They have brought not only excellent experience with regulatory affairs in two different key jurisdictions, but also represent the capability to execute clinical research at their UK facility. We're incredibly pleased to have them as partners.”
-
![]()
“Communication from the team has been outstanding. There has been a lot of valuable scientific and operational input from Clerkenwell on our trial design.”
-
![]()
"We could not be happier with the work done so far by the Clerkenwell team! Their professionalism, attention to detail and clear scientific expertise has been hugely useful to us and their output has far exceeded our expectations. This partnership has already proven to be invaluable to Octarine, allowing us to make significant strides in our R&D plan."
-
![]()
“We've been very impressed with the Clerkenwell team. Their understanding of the unique requirements of psychedelic-assisted therapies and the literature surrounding them allows us to dramatically accelerate our clinical development plans.”
We’re leading the future of clinical research
Our forward-thinking operating model combines the operational consistency and resource access of site networks with the centralised services and oversight of a CRO, setting a new benchmark for trial design and delivery. We’re not just adapting to the future—we’re shaping it.
Integrated trial design and delivery
Our fully integrated model brings a new level of operational sophistication to complex clinical trials. By combining CRO services, trial sites, and advanced supporting technologies, we create valuable synergies that drive both efficiency and precision in trial execution.
With a single point of contracting for multiple sites and principal investigators, we streamline operations while maintaining tight control over trial design and delivery. This integrated approach ensures that trials are not only practical to run but also tailored to optimise the patient experience. By sharing workforce, standardised processes, and technology across all functions, we can design trials that are more efficient, patient-friendly, and deliver better clinical outcomes.
Reliable and efficient patient engagement
We take a patient-centric approach to recruitment and trial delivery, drawing from our extensive experience in mental health care and research. Our focus is on enhancing participant experience from initial contact through to trial completion.
Our multi-channel, adaptable recruitment strategy allows us to rapidly identify and screen participants using the most cost-effective methods. Alongside our highly engaged patient database, we maintain close partnerships with referral sources including patient groups, charities, hospitals, and a trusted network of clinicians and therapists. This model enables us to build a participant pipeline pre-approval and add sites without needing additional regulatory approval.
3-10x
Faster recruitment compared to other sites
48h
Turnaround from sign-up to pre-screening call
93%
Enrolled participant retention
>30k
Vetted UK patient database
Fast site selection and trial set-up
Our dedicated team moves swiftly, offering faster feasibility assessments, onboarding, and training to expedite site selection and trial initiation. By applying a streamlined, systematic approach to site management, we ensure operational excellence from the outset, even for complex or specialised trials. We are also equipped to integrate new technologies and innovative treatment approaches, allowing us to run highly tailored trials.
2 wk
Between sponsor greenlight and first patient screened
2-3 wk
Between site selection and contracting
8-12 wk
Between site selection and first patient
Network of principal investigators and therapists
We’ve built a robust network of principal investigators with extensive experience and a ready-to-deploy pool of therapists trained to the highest standards. With this foundation, we can swiftly assemble the right team to meet the unique demands of your trials.
Recognising the critical role psychological intervention plays in the success of psychedelic trials, we've developed a specialised psychedelic practitioner training program. This program, combined with our rigorous monitoring process, ensures that therapy is delivered consistently across all sites and by all practitioners, safeguarding the integrity and reliability of your trial results.
6
Investigators with experience in 20+ indications
>40
Trained therapists
>1k
practitioners in our database waiting to be trained
Deep expertise in psychiatry & CNS
In psychiatric and CNS research, a one-size-fits-all approach simply doesn’t work. Generalist CROs often rely on standardised, "cookie-cutter" models that overlook the critical nuances of thse patient populations. At our core, we understand that patients face unique challenges, and we’ve built our expertise around addressing these needs with precision and care.
Designing practical and easily deliverable studies requires a deep understanding of both the science and the patient journey. Our experience allows us to develop study designs that not only meet regulatory standards but also optimise the patient experience to ensure recruitment and retention.
15
Psychiatric indications we’ve worked with
100%
of clients said the work we delivered met or exceeded their expectation
100%
of clients think the work we delivered was good or excellent value
85.7%
of clients said they’d be working with us at the next opportunity
Our capabilities
-
Accelerated clinical development pathways
Regulatory advisory
Innovative trial design & protocol development
Support across phase I-III trial design
Focus on operational aspects to ensure optimised delivery
-
FDA, MHRA & EMA approvals
Full submission dossiers
Import / export support
Manage entire submission process
Lead regulator meetings
-
Site set-up & management
Biostatistics & data management
Trial performance management & monitoring
Clerkenwell-owned trial units
Global network of sites proven to deliver
-
Provided as stand-alone service or as part of site delivery
Multi-channel, tech enabled approach
Study-specific approach to deliver precision recruitment strategies
-
Market leading approach to recruiting, training & monitoring therapists in trial context
Ability to ‘white label’ therapy manuals
Processes to monitor and continually improve therapists practice and adherence to manuals