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How long does it take to approve a clinical trial?

BioKinetic works within one of the fastest and most favourable regulatory environments in Europe. The MHRA (UK regulatory body) is committed to processing Phase I CTAs within 14 days. The NHS Research Ethics Committee’s (REC) decision will be sent in writing within 10 working days after the meeting.

Which documents are required for a CTA submission?

When applying for a Clinical Trial Authorisation through the UK’s Competent Authority, the MHRA, you are required to send a range of documents. You can view the list by copying and pasting this link: bit.ly/1mqyQ3w Our internal regulatory team is experienced in determining the acceptability of documents before they are submitted to the regulators to ensure the study is approved at the first time of asking. They will help you through the process or perform this for you on your behalf.

How many staff do you have? What is the structure of your company?

BioKinetic currently has over 50 contracted members of staff and a bank of reserve clinic staff. We have a flat organisational structure to facilitate communication throughout the organisation. Our team is comprised of Doctors, Nurses, Clinic staff, Data/Recruitment specialists, Project Managers, Pharmacists, QPs, QA/Regulatory staff, Business Development, Contracts and Commercial support team.

What services do you offer?

• Clinical trial design – First In Man to Proof of Concept • Protocol development/review • Regulatory affairs • Clinical conduct – Phase I-III • Project Management • Pharmacy & QP Services • Medical Writing • Data Management, Statistical Analysis and Bioanalysis (through strategic alliance partners)

Does BioKinetic offer statistical analysis and bioanalysis services?

BioKinetic offers statistical analysis or bioanalysis services onsite through our strategic alliance partners (hyperlink). All our strategic partners are audited as part of the BioKinetic Quality Control process. We are also happy to work with Sponsor’s preferred vendors.

Where are you located? What are your facilities?

BioKinetic is based in Belfast city centre (UK), on a single site within a multi-purpose building. Our unit is easily accessible for local volunteers by car, rail and bus and for clients via Belfast and Dublin airports. We have 2 GCP GMP compliant clinics with a capacity of 42 beds which can run concurrently with our separate outpatient unit. To see images of our facility please go to the Volunteers > Facilities section of the website.

How is a trial managed?

All trials are given a designated project manager on study award, who will act as the primary point of contact and work to an agreed communication plan, disseminating all information to BioKinetic staff and managing subcontractors. Our Project Managers are flexible and understand that the needs of your project can change unexpectedly. They will keep you informed as every element of the trial progresses.

How many study participants can you accommodate at any one time?

We have two clinical pharmacology units with 40 beds in total. We also have a separate outpatient unit that allows us to run inpatient and outpatient patient simultaneously.

How many volunteers are currently on your database? Do you have patient populations?

We currently have over 30,000 volunteers on our database, the majority of whom are healthy volunteers. We also have a range of patient populations such as diabetics, hypertensives, asthma, COPD, postmenopausal/tubally-ligated women. We have a dedicated recruitment team who are specialised in recruitment strategies for hard to reach populations.

How do you recruit volunteers?

We recruit volunteers primarily through our bespoke Study Management System that currently has over 30,000 active volunteers, the majority of whom are healthy volunteers. We also have various patient populations. We contact potentially suitable volunteers by telephone and email and are adept at creating and running study specific advertising campaigns incorporating TV, radio, press and digital media to ensure we hit our recruitment targets on time and in a cost effective manner.

Can you import comparator drug? What is the process?

BioKinetic works with clinical trial supply companies who are experienced in accessing non-UK controlled drugs, managing import permit applications and identifying comparator drug supply routes. BioKinetic can facilitate audits of non-EEA manufacturing sites and has acted as a legal representative for non-EEA Sponsors.

Which controlled drugs can you handle at your facility?

BioKinetic holds a licence for working with Schedule II-IV controlled drugs.

Do you have client references?

Yes. Client references are available on request.

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