BioKinetic Europe

BioKinetic Europe is an independent, owner-managed early phase Clinical Research Organisation in Belfast, Northern Ireland. We specialise in innovative and adaptive clinical trial design and the meticulous conduct of clinical trials at our 40-bed facility in Belfast city centre. Our areas of expertise lie in Women’s Health, Vaccines, Diabetes, Pain Management and Respiratory. As well as healthy volunteers, we have successfully delivered patient studies requiring healthy elderly volunteers, post-menopausal women, women with dysmenorrhea and PCOS, volunteers with asthma, diabetes/prediabetes and rheumatoid arthritis among other conditions. We have successfully completed MHRA (UK Regulatory Body) GCP and GMP Inspections and have held Supplementary Accreditation since 2009. With a 14-day approval timeline for Phase I CTAs and Research Ethics Committee decisions, BioKinetic works within one of the fastest and most favourable regulatory climates in Europe. The company currently employs over 50 contracted staff with extensive experience and ongoing training in the clinical trials process. Types of Studies: First Administration to Man Proof of Concept TQTc Drug Delivery Drug/Drug Interaction Vaccines Pharmacodynamics / Pharmacokinetics Food Effect Bioequivalence Bioavailability Biosimilar Service Offer: Clinical trial design Protocol development / review Clinical conduct Regulatory affairs Medical writing Pharmacy and QP services Data management, statistical analysis and bioanalysis (through partner organizations)