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BioKinetic has an excellent working relationship with the local regional ethics committees and the UK competent authority, MHRA.

Our internal regulatory team will walk through the approval process with you for a ‘right first time’ submission. Within the favourable UK regulatory environment, there is a:

  • Guaranteed 14-day turnaround for Phase I CTA
  • Guaranteed 14-day turnaround for Phase I REC/IRB

In addition to ICH GCP compliance, BioKinetic Europe operates within the UK (MHRA) and EU (EMEA) regulatory frameworks. We have successfully completed both MHRA GCP and GMP inspections and are holders of a current Manufacturing Authorisation for IMP, which includes vaccines. BioKinetic is a holder of controlled drugs licences for schedule II-IV drugs.

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Regulatory Metrics

  • 100% of our studies are submitted within REC timeframes
  • REC/IRB committees give verbal legally binding opinions on the meeting date so volunteer screening can begin. A signed REC letter of opinion is sent via email to expedite study start.
  • Phase I CTAs submitted by BioKinetic receive competent authority (CA) opinion within 14 days. UK CA are committed to achieving this.
  • REC submissions – a 7 day turnaround from final protocol to submission with our internal regulatory experts.
  • 99% of our studies have started full in the last 2 years.
  • A strong collaborative relationship, spanning almost 20 years with LREC and UK CA.

How does it work?

  • Feasibility & Study Award

  • Regulatory approvals

  • Trial conduct

  • Database lock, review of CSR, study close-out