BioKinetic Europe is a clinical research organization celebrating its 20th anniversary of conducting clinical trials in Northern Ireland. It has significant experience managing Phase I-III trials for pharmaceutical companies. Recently, BioKinetic invested in a new electronic data capture system called ALPHADAS to improve efficiency and reduce monitoring costs. As an experienced CRO located in Northern Ireland with strong university partnerships, BioKinetic provides flexible and high-quality clinical trial services to pharmaceutical and biotech clients.

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‘CELEBRATING 20 YEARS OF INNOVATION IN THE PHARMA SECTOR AS A LEADING CONTRIBUTOR TO THE
KNOWLEDGE ECONOMY IN NORTHERN IRELAND.’
Since its inception in 1996, BioKinetic Europe has developed a reputation for meticulously managing Phase I – III
studies on behalf of pharmaceutical companies in the UK, Europe, the US and Korea. Co-founded by Dr David Bell and
two fellow directors, the company has seen significant growth over the last 20 years as a result of strategic leadership,
a flexible approach to early phase clinical research, and a commitment to continuous improvement.
Today, BioKinetic Europe specialises in adaptive clinical trial design and study conduct at its 40-bed facility in Belfast
city centre located close to major airports and arterial routes. With in-house experience of over 400 clinical trials, 50
full-time members of staff and a database of 30,000 potential clinical trial volunteers, BioKinetic is the CRO of choice
for the company’s global network of clients.
CLIENT PROFILES
 Small, medium and large Pharma
 Biotech
 Universities
 University spin-outs
 Medical device companies
 CRO partners
 FP7 and H2020 consortia
BioKinetic Europe received the ‘Pharma Contract Services Company of the Year 2015 Award’ as well as being placed
as a finalist for the ‘Pharma Industry Company of the Year Award’, which endorses the company’s strong position in
the Pharma Sector in both Northern Ireland and the Republic of Ireland. These accolades have further galvanised the
company’s strategic vision to achieve best-in-class industry status in the future.
BioKineticEurope has formed strong strategicalliances withleading global Life Sciences companies to include specialist
statistics and bioanalytical groups. Through this collaborative approach, BioKinetic can offer an enhanced portfolio of
services ensuring clients receive comprehensive, bespoke solutions.
As part of its strategy to develop the Life Sciences sector, Northern Ireland can provide high levels of support for
companies. This is underpinned by a culture of innovation and government-led action to promote the transfer of
leading edge technologies from laboratory to production line.
In 2014, BioKinetic Europe received what is believed to be the largest ever FP7 Health grant awarded to a
private Northern Irish company for the development of a novel vaccine against
Group B Streptococcus (GBS).

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ALPHADAS® TO ENABLE BIOKINETIC TO ACCELERATE AND STREAMLINE PROCESSES
BioKinetic Europe has recently invested heavily in the implementation of ALPHADAS®, a state-of-the-art Electronic
Data Capture (EDC) system to support operational efficiency and industry competitiveness. ALPHADAS® has a proven
record of being used in live clinical trials for over a decade, across 4 continents. The software captures data at the
bedside directly from source instrumentation (no transcription), virtually eliminating data queries and enhancing
compliance. The introduction of the software will significantly reduce onsite monitoring by up to 75% as well as
providing clients with remote real time data monitoring, in turn reducing the frequency of client travel to the facility.
Specialist Areas
 Women’s Health
 Diabetes
 Vaccines
 Ophthalmology
 Respiratory
 Medical Devices
Complete Range of Services
 Clinical Trial Design
 Phase IIa Drug Development
 Protocol Development
 Clinical Conduct
 Regulatory Affairs
 Medical Writing
 Pharmacy and QP Services
 Data Management
 Statistical Analysis and Bioanalysis (through partner organisation)
 Electronic Data Capture (EDC)
Types of Studies
 First-in-Human
 Proof of Concept
 TQTc
 Drug Delivery
 Drug/Drug Interaction
 Vaccines
 PK/PD
 Food Effect
 Bioequivalence and Bioavailability
BioKinetic Europe is focused on delivering a high quality,
cost effective service, on time and within budget.
BioKinetic Europe, the lifeforce behind drug development through insightful and flexible trial design.

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WHY CHOOSE BIOKINETIC EUROPE?
BioKinetic Europe is a trusted partner in early phase clinical research and is committed to its clients’ success. As an
independent CRO with a flat organisation structure, BioKinetic can provide the agility and responsiveness required for
early phase decisions within drug development programmes. As recognised experts in First-in-Man studies and
adaptive clinical trial design, the company’s strength lies in its integrity and personal service to ensure clinical trial
objectives are met. The company boasts the highest standard of Supplementary Accreditation (MHRA), GCP and GMP
compliance which provides clients with assurance that their trial is in safe hands.
FACULTY OF PHARMACEUTICAL MEDICINE
BioKinetic Europe is an educational training unit, approved by the Faculty of Pharmaceutical Medicine and employs a
range of Principal Investigators and Clinical Research Professionals experienced in clinical trials across a wide range of
therapeutic areas. Dr David Bell is both an Educational Supervisor for the Faculty and Senior Advisor to the Faculty.
Northern Ireland has an international reputation for providing clinical trial services to the world's leading
pharmaceutical companies and is a prime location for biotechnology and pharmaceutical companies, thanks to a long
history of technological innovation, backed by a highly educated, young workforce and an internationally recognised
research base.
Given BioKinetic’s close proximity to leading universities including Queen’s University Belfast and Ulster University, it
has the advantage of having access to local biomedical talent and resources in Northern Ireland.
BioKinetic Europe is committed to attracting and nurturing talent through education and currently has 4 doctors
undertaking higher medical training in pharmaceutical medicine on-site which offers clients first class clinical services
and superior products.
It was recently announced in the Guardian League Table 2017 that the Ulster University is officially the top university
in the UK for studying pharmacy and pharmaceutical sciences, a position it has held for the
last three years in succession.
Queen’s University Belfast is recognised as a world leader in cancer research.
In 2012, it was awarded the Queen’s Anniversary Prize for world-class achievement through its leadership of the
Northern Ireland Comprehensive Cancer Services programmes.
- BioKinetic operates within one of the fastest and most favourable regulatory climates in Europe (14 days for Phase
1 CTA and REC)
- Excellent working relationship with both the MHRA and REC
- Achievable 7-day turnaround from final protocol to ethics submission
- Studies are filled efficiently and effectively through a register of 30,000 volunteers
- A dedicated Project Manager acts as a single point of contact to keep sponsors informed at every point of their
trial
- Flexibility in utilising sponsor EDC/eCRF system of choice through BioKinetic’s extensive experience
- BioKinetic can provide a 2-week timeline from LPLV to database lock
- Monitoring time is minimised with 100% source data verification carried out by a dedicated data team for non EDC
data and EDC data via the new Alphadas system allows remote monitoring
BioKinetic Europe are keen to work collaboratively with sponsor clinical research teams to design a programme of
early Phase I/II studies best suited to their drugs' needs.