

OUR EXPERTISE AND SERVICES
SCIENTIFIC ADVISORY WORK
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Consultation on scientific merits of novel molecules and devices
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Planning pathways for drug and device registration
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Problem solving during various stage of development
SITE MANAGEMENT ORGANIZATION (SMO)SERVICES
We Provide services to sponsors, other CROs, or sites:
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Contract
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IRB submission
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Patient recruitment and follow up
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Adverse events reporting
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Ensuring protocol compliance
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Patient recruitment support
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Principal Investigator support
PATIENT RECRUITMENT
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Expansive network of patients with database of 20,000+ Chinese patients for rapid recruitment in Hong Kong
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Validated methods of recruitment by electronic media
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Community outreach activities with 100+ community organizations
STUDY DESIGN AND IMPLEMENTATION
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Dedicated clinical trials clinic
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Conduct of trials in-house, from patient recruitment, screening, randomization, follow-up, eCRF entry, AE and SAE assessment, preparation and attendance in audits, to drug registration.
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Scientific advice design of phase 2,3, and 4 trials
REGULATORY AFFAIRS CONSULTATION
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Our team advises on the most up-to-date regulatory and ethic requirements in China and Hong Kong to ensure that all trials are compliant with local legislation and regulations.
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Strong experience with global regulatory authority audits including FDA (USA) and EMEA (European Union) leading to trial drugs registered globally.
QUALITY ASSURANCE
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Dedicated QA and QC team
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Real-time response to queries by investigators and coordinators.