1 / 13

Enriching Drug Development through Insightful Trial Design

Enriching Drug Development through Insightful Trial Design. BioKinetic – who we are?. 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

eilis
Télécharger la présentation

Enriching Drug Development through Insightful Trial Design

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Enriching Drug Development through Insightful Trial Design

  2. BioKinetic – who we are?

  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 • TQTcstudies • 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

  9. 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

  10. Approval Pathway Screening Expression of interest database 14Days StudyPlacementAgreement EthicsApproval FinalProtocol EthicsSubmission StudyCommencement 14Days CTASubmission CTAApproval Set dates for Screening & Dosing Time

  11. Key Expertise

  12. 10 Reasons why Clients Work with us 1. MHRA Supplementary Accreditation 2. 14 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!

More Related