I would like to know more about BioKinetic Europe’s location and why the Company is situated there.
Located in Belfast, N. Ireland, BioKinetic Europe has the benefit of operating within the exceptionally favourable UK regulatory environment where a Phase I CTA is approved in 14 days. We are easily accessible to volunteers and clients alike. For clients, the city is serviced by 2 international airports. For volunteers, our city centre location is accessed easily by local bus and rail networks. The Greater Belfast area has a population of 1 million and as a University City with 40,000 students, our catchment area facilitates the timely recruitment of volunteers for studies. An interesting fact about Belfast is that it is the fifth most visited Eropean city.
How many volunteers are on the BioKinetic Europe database?
BioKinetic Europe has a database of 11,500 active volunteers, with over 9000 males and females in the 18 – 40 age group, 800 males in the 40+ age group and 500 females of non-childbearing potential.
Does BioKinetic Europe have any special populations?
As well as healthy elderly and women of non-child bearing potential, BioKinetic's active database also includes volunteers with diabetes, pre-diabetes (Impaired Glucose Tolerance - IGT), asthma and high blood pressure.
What are the timelines for approval at BioKinetic Europe, with both Ethics and Competent Authorities with both REC and CA (MHRA)?
BioKinetic Europe works within an exceptionally favourable regulatory environment. REC and MHRA CTA
applications can be submitted in parallel or sequentially with REC approval within 21 days and Phase I CTA approval in 14 days. This is among the fastest in Europe and BioKinetic
Europe facilitates the process for our clients. All CTAs submitted by BioKinetic Europe have been approved in 14 days.
Has BioKinetic Europe been audited by the Regulatory
Authority (MHRA) and/or Clients?
BioKinetic Europe has successfully completed both MHRA (UK Regulatory) GCP and GMP inspections in April 2009. Sponsor study and site audits are regularly conducted and client references are available on request.
How is the BioKinetic Europe structured?
BioKinetic Europe operates a flat structure to ensure ease of communication and responsiveness to clients. We have 25 highly-trained staff to ensure clients receive the highest quality of clinical conduct. Staff turnover of less than 2% is testament to the strong team culture and quality of working environment we have achieved.
Can you describe your facilities?
BioKinetic Europe is a modern, comfortable 40-bed facility based in the heart of Belfast City Centre. We have an on-site GMP compliant pharmacy and our clinic is located on one floor to maximise volunteer monitoring and safety. Our clinic has all the modern equipment to cater for our clients’ clinical pharmacology study requirements.
What are BioKinetic Europe’s core competencies?
As a Phase 1 Clinical Pharmacology company, BioKinetic Europe has in-house experience of over 400 clinical trials. We conduct all types of Phase I studies with particular emphasis on First Time in Man (FTIM), Thorough QTc and vaccine studies.
What services can be offered in addition?
In collaboration with our partner companies BioKinetic Europe offer protocol design and writing, regulatory affairs, clinical conduct, case report design and printing, bioanalysis, data management and statistical analysis as well as final study report for regulatory submission.
Who are BioKinetic Europe’s clients?
BioKinetic Europe works with all companies contracting out Phase I-II clinical trials, from Global to Small Pharmaceutical companies, Biotechnology companies, SMOs, Generic and Vaccine companies. Our current client portfolio spans the globe from the USA to Europe and Japan.
What therapeutic areas does BioKinetic Europe cover?
BioKinetic Europe has conducted clinical trials across all therapeutic areas.
Who should I contact for additional information?
Please contact Moira T Burke, Managing Director, email: contact@biokineticeurope.com
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