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Enriching Drug Development through Insightful Trial Design.
Transcript of Enriching Drug Development through Insightful Trial Design.
Enriching Drug Development through Insightful Trial Design
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!
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)
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
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
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
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
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
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
StudyPlacementAgreement
Expression of interest database
FinalProtocol
EthicsSubmission
Time
EthicsApproval
CTASubmission
14Days
Set dates for
Screening&
Dosing
CTAApproval
StudyCommencement
Screening
Approval Pathway
14Days
Key Expertise
1• Women’s Health
2• Dermatology & Transdermals
3• Pain Management & Arthritis
4 • TQTc & Cardiology
5• Vaccines
6• Diabetes & Prediabetes
10 Reasons why Clients Work with us1. MHRA Supplementary Accreditation2. 14 day approval timeline3. Trial design expertise4. Extended capability (in-house & outpatient)5. Database of 17,000 volunteers
6. 100% QC on all source data7. Long serving senior staff8. Strategic alliances for comprehensive solutions 9. Training unit for Faculty of Pharmaceutical Medicine 10. We make our clients happy!