Doctor's Visit

OUR EXPERTISE AND SERVICES

SCIENTIFIC ADVISORY WORK

  • Consultation on scientific merits of novel molecules and devices

  • Planning pathways for drug and device registration

  • Problem solving during various stage of development

SITE MANAGEMENT ORGANIZATION (SMO)SERVICES

We Provide services to sponsors, other CROs, or sites:

  • Contract

  • IRB submission

  • Patient recruitment and follow up

  • Adverse events reporting

  • Ensuring protocol compliance

  • Patient recruitment support

  • Principal Investigator support

PATIENT RECRUITMENT

  • Expansive network of patients with database of 20,000+ Chinese patients for rapid recruitment in Hong Kong

  • Validated methods of recruitment by electronic media

  • Community outreach activities with 100+ community organizations

STUDY DESIGN AND IMPLEMENTATION

  • Dedicated clinical trials clinic

  • 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.

  • Scientific advice design of phase 2,3, and 4 trials

REGULATORY AFFAIRS CONSULTATION 

  • 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.

  • Strong experience with global regulatory authority audits including FDA (USA), NMPA (China) and EMEA (European Union) leading to trial drugs registered globally.

 QUALITY ASSURANCE

  • Dedicated QA and QC team

  • Real-time response to queries by investigators and coordinators.