Case Study: support for patients within a clinical trial involving psychedelic compounds
Background
Psychedelic compounds have long been identified for having possible therapeutic benefits but due to their controlled drug statuses (Schedule I in the US, and Class A in the UK) they can be difficult to research, having cultural impacts as well as medicinal challenges.
Formed in 2019, Beckley Psytech was created to build upon the Beckley Foundation’s work by developing safe and effective psychedelic medicines for patients in need, and integrating these treatments into mainstream medical practices.
Psychedelic compounds have long been identified for having possible therapeutic benefit.
How the client needed support
In 2020 ESMS (Emergency Scientific and Medical Services) were approached by Beckley Psytech to support the launch of their first in human safety study on 5-MeO-DMT (BPL–5MEO), an experimental new treatment for Treatment-Resistant Depression.
In our continued relationship, Beckley further required ESMS to support their continued portfolio as research progresses.
How we helped the client to deliver
ESMS are experienced at providing trial-specific support across therapy area and phases. Our unique association to one of the world’s leading teaching hospitals, Guy’s, and St Thomas’ NHS Foundation Trust, means that we have practicing Senior Physicians who join our calls, within a maximum wait time of 15 minutes, to provide any emergency medical advice 24 hours a day satisfying the requirements of GCP (Good Clinical Practice).
ESMS worked with the Beckley Psytech team to design a smooth emergency support service and for the first in patient trial, which had a randomised double-blind design, ESMS held the treatment allocation details so that controlled, rapid emergency unblinding could be performed if needed. Ensuring oversight and patient safety were prioritised.
Adverse events
Central codebreaking support also ensures code breaks do not go accidentally undetected and our central 24/7 availability allows capture of any AEs (adverse events) that occur outside of the Phase 1 site to be fully documented, allowing a full picture of safety profiles to be collected.
Outcome and benefits for the client
We take pride in our ability to offer bespoke services tailored to our clients and their respective clinical trials.
Choosing ESMS as the single provider for this service for Beckley trials provides patients with access to experienced, trained staff. ESMS provides a GCP compliant, robust 24/7 service supporting patients and the healthcare professionals responsible for treating them.
Provided by our qualified scientific team of Information Scientists and experienced, practicing Senior Consultant Physicians.
The team have immediate access to trial documents, a medical response time within 15 minutes and emergency unblinding time within a maximum of 30 minutes. All enquiries are audio recorded, quality checked and reported to the client within 24 hours.
“Amazing service provided by ESMS, we really appreciate the help and regular catchup meetings to ensure the service is running smoothly and that any issues are addressed. Since working with ESMS, we have yet to encounter any problem.”
Want to know more?
Complete our enquiry form today, or email us at info@esmsglobal.com to find out how we can support your next study.
