BioKinetic Europe is one of the UK’s leading early phase clinical research organizations with experience in over 400 clinical trials. Our Phase I portfolio comprises BE/BA studies, SAD/MAD/Proof of Concept, TQTc, DDI, vaccine and medical device studies.
Volunteer database
At BioKinetic we pride ourselves in the meticulous management of our volunteer database, because we know that fully informed, compliant volunteers recruited in a timely fashion are imperative to a successful trial. Our volunteer database currently boasts 20,000 active volunteers, made up primarily of healthy volunteers aged between 18-55 but also various patient populations including rheumatoid arthritis, women with uterine fibroids, asthma/COPD and diabetics (Type 1 and 2).
The BioKinetic team works collaboratively with Sponsor personnel to clearly define protocol requirements and inclusion/exclusion criteria. As a result, we consistently provide and even exceed our number of required participants for trials.
For particularly difficult to reach populations or studies involving a large number of subjects, we routinely devise bespoke recruitment strategies and design advertising campaigns with a partner advertising agency to ensure we meet the trial timelines and targets.
Experienced in competitive recruitment
BioKinetic has participated in a range of studies across a range of therapeutic areas where a competitive recruitment approach was employed by the Sponsor. Specific populations have included: adults and adolescents with asthma/COPD; tubally-ligated women; and women with PCOS. For each of these studies we exceeded our agreed recruitment targets and were the top recruiting site in Europe.
Multi-centre approach
Where large numbers of volunteers are required, we are comfortable acting in a multi-centre setup as a coordinator or participant. We work with various sites in Germany, Belgium and France to expedite overall recruitment and study timelines and can bring on some or all of those partners as each study’s needs dictate.
Fast and favourable regulatory environment
Based in the UK, we benefit from the 14-day approval timeline for Phase I CTAs and REC. Our regulatory team at BioKinetic have good working relationships with local regional ethics committees and the UK competent authority, MHRA which gives every study the best possible chance of being approved first time.
Case study: Agility in study start-up
BioKinetic was approached by a client CRO to run a trial they had committed to but could no longer accommodate in-house. The Sponsor needed an experienced Clinical Pharmacology Unit that could run a dose-escalation trial for a biosimilar product with the fastest possible set-up times and the CRO needed to use a unit they could trust to deliver for their client. Regulatory approval had already been granted so a Substantial Amendment and REC approval were required.
The BioKinetic team moved swiftly to review the protocol, set up a client site qualification audit and provide a detailed timeline and Gannt chart to illustrate approval timelines and trial deliverables through to CSR. The time between the initial phone call enquiry to first subject first visit was under 8 weeks. All cohorts were recruited and dosed as scheduled with database lock secured as per original agreed timeline with client CRO. The outcome was that the CRO retained their important client and the Sponsor has promised us repeat business.
To find out more about BioKinetic’s capabilities and how we can help in your biosimilar trial, please contact us on
clients@biokineticeurope.com
or call us on +44 (0) 2890 81 83 81
