presentation - phase 1 & ba/be process flow
DESCRIPTION
Timelines, Regulatory ProcessTRANSCRIPT
Info Kinetics Sdn Bhd / Clinical Research Centre Connecting Research & People
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May 2010
Phase 1 Study
BA/BE Study
Protocol Development
IRB / IECApplications
Pantai Hospital Penang
Bioanalytical
Regulatory Applications
Data Management& Reporting
Subject/Patient
BE StudyPhase 1 Study
Full Services Under One Roof
Accreditation
Facility
Timelines
Cost
Request for Information (RFI)
Market Authorisation
R&D StrategiesStandards
2001-2002 2003-2004 2005-2006 2007-2008 2009-2010
• Company Established
• First BE Study performed.• Complied with ICH-GCP• First CRO to obtain ISO 9001:2000
• Inspections from NPCB and HSA• Achieved ISO/IEC 17025 accreditation.• Quality manual aligned with ASCLD
• First Asian CRO to obtain OECD GLP accreditation• Inspected by German Federal Bureau
• GCP Inspection by French regulatory authorities (Afssaps)• GCP Inspection from NPCB (renewal)
Quality Milestones
Info Kinetics is the first CRO is Pan-Asia to achieve ISO9001:2000 and OECD GLP accreditation
• Migration to ISO9001:2008
36-bedded facility
Large Database ofsubjects
Pantai Hospital PenangLimited Access
Drug Storage area
Phlebotomy Stations FreezersRefrigerated Centrifuge
Clinical Pharmacology Unit
Full safety supportICU & 24-hr emergencyRFID Subject
Tracking System
Bioanalytical Laboratory
Over 70 validated methods (plasma)
Over 40 validated methods (pharmaceutical)
LCMS/MS (2)GCMS (2)RRLC / UPLC (6)
Agilent OpenLab® Platform
Pre-Study Timelines
2 d
1 - 2 wks
4 - 6 wks
Timelines Financial & LegalOperationsSponsor
Request for Information (RFI)Feasibility Studies
(Facility Audit)
Accepts Proposal
Protocol WritingInform Consent FormsCase Report Forms
IEC Application(Approval)
TCECDA
Regulatory Application
(CTIL) / (NMRR)
Study AgreementIndemnity
Provide Technical Dossier
Provide Working Stds Method Development & Validation (if not validated)[4-6 weeks]
1 - 2 wks
Study Timelines
2 wks
2 - 4 wks
4 - 6 wks
2 - 3 wks
2 - 3 wks
Timelines FinancialOperationsSponsor
Ship IMP to Site Subject Screening & Recruitment
12-16 wks
Monitoring Visits Study Period 1(washout period)Study Period 2
Safety Follow-up
Bioanalysis
Data Management & Statistical Analysis
Report Writing &Study Closure
Application
• Applicant must be Malaysian Registered Organisation, with appropriate personnel
• Parallel submission to Drug Control Authority & National Medical Research Register
• Language: English• Dossier Format: Common
Technical Dossier
Review
• Monthly Meeting• Safety & Quality aspects• Ethical aspect is the
responsibility of Ethics Committee.
• First in Man: New Chemical Entity (NCE) is acceptable
• First in Man: New Biological Entity, slower process
Approval
• A Clinical Trial Import License is provided. Valid for 2 years.
The Malaysian Govt. is very supportive of Translational Research. Day 1Day -21 Day 7
Regulatory Applications
IRB / IEC Applications
Application
• State ethics committee – accepts application from Penang State
• Parallel submission with regulatory
• Language: English• All forms available online, and
JPEC has its own set of SOPs, under ISO9001
Review
• Monthly Meeting• 12 Member (9 Medical
Professional, 3 layperson)• Registered with OHRP, hence
able to review trials for US NIH.
Approval
• A decision is made known to the applicant within 1 week from meeting date.
• Approved protocol to commence within 18 months.
Independent Ethics Committee (JPEC) – ICH GCP standardsDay 1Day -21 Day 7
Accreditation
Facility
Timelines
Cost
Request for Information (RFI)
Market Authorisation
StandardsR&D Strategies
Market Authorisation
• Which market / regulatory agency is the study intended for?
• Choice of Reference / Comparator
• Narcotics / Psychotropics
Standards
• Local authorities
• EMEA
• TGA
•US FDA
• GLP vs non-GLP
R&D Strategies
• Pivotal Study
• Pilot / Exploratory Study
• What developmental stage? Comparative Dissolutions Stability Studies Bio-batch production
Request for Information (RFI)