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Through partnership with Sonic Clinical Trials, Pharmaceutical Solutions provides access to a dedicated central laboratory exclusively in support of clinical trials.
Sonic Clinical Trials is a wholly owned subsidiary of Sonic Healthcare Limited; one of the world’s largest specialist medical diagnostics companies, Sonic Clinical Trials offers high-quality results through technical excellence from a state-of-the-art pathology and clinical trials facilities located in Sydney.
Sonic Clinical Trials offers a comprehensive portfolio of laboratory services including:
} Protocol Management Services:
} Project Management - Experienced Project Manager, Clinical Pathologists and medical laboratory scientists work closely with clients to anticipate study needs.
} Kit Assembly - Provision of protocol, visit, investigator specific collection kits, Laboratory services manual, including Lab certifications and reference ranges. (Translation service also available)
} Client Support Services – Specialist staff with expert knowledge providing investigator support and professional training
} Logistics Coordination – Complete courier management, Door to door service for both imports and exports, DG Training for sites when required
} Laboratory Services:
} Standardised validated testing platforms, methods & reference ranges, routine and esoteric testing capabilities
} Biochemistry, Haematology, Microbiology,Immunoserology,Drug Screening, Cytology, Anatomical Pathology, Molecular Biology, Histology
} Ability to validate new assays in-house or within Sonic Healthcare Laboratories
} Sample Management Services:
} Sophisticated sample management system ensures complete chain of custody
} Secure ambient, refrigerated and frozen facilities. Alarmed and monitored
} Short & long term storage; including shipping to Referral laboratories
} Data Management Services:
} Experienced Data Management team in Sonic UK (The Doctors Laboratory – TDL Trials)
} Formats are available for upload by FTP, secure email and secure portal; Data Options available:
} SAS data sets
} Pivotal table
} Client specified formats
} ASCII (delim, fixed, CSV)
} Quality Assurance:
} Sonic Clinical Trials is accredited to ISO 15189 by the joint NATA / RCPA program for medical laboratories & warrants compliance with ICH GCP.
} NGSP certification for HBA1C and CDC Lipids certification
} Systems are fully validated to GAMP4/5 requirements and designed to ensure compliance with global (GCP / US 21CFR11) and local requirements (TGA / NATA) requirements for data integrity.
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