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Phoenix Pharma Central Services
11 Changi North Street 1, #04-05/08
Changi North Industrial Estate
Singapore 498823
Ph: 65-6542-4784
Fax: 65-6542-7238
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" Quality Assured... "
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Central Laboratory Services
- Phase I to IV Clinical Trials
Central Laboratory Testing Services
- Automated serum and urine Chemistries
- Automated Full Blood Count and 5-part differentials
- Urinalysis
- Serology
- Endocrinology
- Immunology
- Basic Microbiology
- PCR
- Glycated Haemoglobin (HbA1c)
- Tumour markers
Central Laboratory Basic Support Services
- Visit Specific Kits and request form
- Investigator manuals
- Investigator Training and Support
- Sponsor Support
- Dedicated Project Manager from start to finish
- Project Manager to serve as primary liaison for all communication
- Project monitoring
- Site and courier initiation for project start up
- Safety and efficacy monitoring
- Phoenix designed UN shippers for ambient and dry ice shipment
Logistics
- IATA-certified Professionals
- Organized the supply of centrifuges and dry ice to sites
- Logistic and courier Professionals to assist with daily operation
- Samples can be forwarded to whatever destination within or outside Asia
- Preprinted airway bills
- Prepared proforma invoice, dangerous goods declaration
Computerisation
- Protocol driven Computer System
- Laboratory Information System interfaced with instrument
- Data cleaning and export
- Management report
- Continous software development, validation and verification
Language
- Multi-Asian language and multi-dialect capabilities
- Translation service
Customised Services
- Correlation studies
- Standardisation of laboratories for combinability of data
- Diagnostic consultant services
- Tests and Technology development
- Stability study of analytes
- Computerised Real Time Specimen Management System (RT-SMS)
- Electronic data transmission
- Cumulative reporting of laboratory data
- Storage of samples at ultra low temperature
- Supply of near patient testing kits or point of care testing
- Visit specific lab kits or bulk supplies
- Protocol specific documents such as requisition forms and results reports
- Storage of raw data for 15 years
- Project cost tracking
- Laboratory audit services of local and Asia referral laboratories
Quality Assurance
- Singapore Ministry of Health Clinical Laboratory License
- Singapore Ministry of Health Proficiency Testing for HIV,
WHO for Hepatitis
- College of American Pathologist proficiency testing
- RCPA Quality Assurance Programs Pty Limited
- Working towards accreditation by CAP and level 1 National
Glycohemoglobin Standardisation for HbA1c
- Utilisation of third party quality control testing material
- Half-yearly Internal Audit
- External audit by clients
- Rigorous implementation of standard operating procedures
- Adherence to GCP (clinical laboratory) guidelines
- ICH GCP trained professionals
- Intensive monitoring of both external and internal QC data
Operational Hours
Turnaround Time
- Same day for all routine tests
- Per agreement for non-routine tests
Report Format
- Phoenix default or protocol specified reference ranges
- Customized sponsor specified flagging of results, clinical significance and etiology comments
- Comment on specimen and test results affected by the nature of specimen, e.g. lipaemic, haemolysis, icteric
- Blinding of results, if applicable
- Conventional or SI units of reporting
- Secured database access by sponsor
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Updates |
10.12.03
28.07.02
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Resources |
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