1. Enriching Drug Development through Insightful Trial Design

2. BioKinetic – who we are? European focus
One of the few remaining independent, owner-managed Phase I/II CROs in the UK & Ireland
Committed to providing a fast and flexible service to our clients
Long-term staff dedicated to providing excellent clinical research
A trusted advisor!

3. What we do Clinical trial design – FIM to PoC
Protocol development/review
Regulatory affairs
Clinical conduct – Phase I-III
Project Management
Pharmacy & QP Services
Medical Writing
DM&SA and Bioanalysis (through strategic alliance partners)

4. Broad Experience in Phase 1
Over 100 studies in current unit
PK/PD – Proof of concept studies
Bioequivalence studies
NCE programmes
Interaction studies
HRT studies
Skin assessments
Vaccines
TQTc studies
Biosimilars

5. Broad Experience In Other Phases
Phase IIa, IIb & III studies
Diabetes
Impaired Glucose Tolerance
Women’s Health
Arthritis and Pain
Vaccine
Transdermal
Dermatology
Asthma/COPD
Access to Network of Specialist Consultants

6. Clinic Information
MHRA Phase I Supplementary and Standard Accreditation
GCP and GMP Compliant Facility
Access-controlled 30-bed unit, located on one-floor to maximise volunteer monitoring and safety
Access-controlled 8-bed unit for intensive monitoring studies
Access-controlled separate outpatient and screening rooms
Designated dosing, phlebotomy and processing areas
Recreation and dining areas

7. Current Volunteer Database
Over 17,000 volunteers
7,300 healthy M / F , 18-65years
181 healthy m / f volunteers, over 65
Obese volunteers: 756
T1DM : 106
T2DM diet : 44
T2DM Ins : 34
T2DM Oral : 276
Hypertension : 133
Healthy smokers : 1,813
Skin conditions : 28
Asthma/COPD : 1651/572
Arthritis : 234
RA: 297
Post-menopausal women : 699
Figures at 18NOV2013

8. Our Location: Belfast, NI
Belfast City Centre
Easy access via Belfast and Dublin airports
Population of Greater Belfast – 500,000
Easy access for clients and volunteers

10. Unique Operating Environment
14 days for Phase I CTA/14 days for REC approvals
Recruitment capability of whole of Ireland
Cross-border links with Intertrade Ireland & Enterprise Ireland
Not competing for volunteer or patient populations

11. Expression of interest database
Approval Pathway
Expression of interest database
Screening
14 Days
Study Placement Agreement
Final Protocol
Ethics Submission
Ethics Approval
Study Commencement
14 Days
CTA Submission
CTA Approval
Set dates
for
Screening
&
Dosing
Time

12. Key Expertise Women’s Health Dermatology & Transdermals1
Women’s Health 2
Dermatology & Transdermals 3
Pain Management & Arthritis 4
TQTc & Cardiology 5
Vaccines 6
Diabetes & Prediabetes

13. 10 Reasons why Clients Work with us
1. MHRA Supplementary Accreditation
day approval timeline
3. Trial design expertise
4. Extended capability (in-house & outpatient)
5. Database of 17,000 volunteers
6. 100% QC on all source data
7. Long serving senior staff
8. Strategic alliances for comprehensive solutions
9. Training unit for Faculty of Pharmaceutical Medicine
10. We make our clients happy!