ChulaCRC is ready to support all investigators to perform clinical study for both Investigator initiated and Sponsor initiated study. Our staff will conduct all studies in accordance with approved protocols, institutional requirements, SOP, Good Clinical Practice (GCP) guidelines, sponsor criteria and other regulatory requirements. Services providing are:

  • Management of regulatory/IRB documents: preparing of study document for EC/ IRB submissions, RA submissions, inspections and audits.
  • Serving as a liaison among investigators, collaborators, providers, the sponsor, and ethical review committee
  • Overall study management by certified and experienced staff (study nurse, pharmacist and study coordinator)
  • Preparation of relevant documents as source data for the study
  • To assist investigators in conducting the study and dealing with the following issues:
    - Obtaining Informed consent/Assent by qualified staff
    - Screening and enrolling eligible subjects to participate in research regarding protocol specifics
    - Performing of study procedures; specimen collection and processing
    - Procedure such as venipuncture and PK capability by qualified study nurse
    - Administration of investigational products by qualified pharmacist i.e. dispensing, storage and perform drug accountability
    - Scheduling and following up of subject visits
    - Coordination of subject study visits with other hospital services
    - Collection of subject data; completion of data collection and record data in Case Report Form
    - Maintenance of Investigator Site File
    - Archiving facilities support with external vendors
 
 
 
 
 
Clinical Research Center - ChulaCRC
Faculty of Medicine, Chulalongkorn University
7th floor, Or Por Ror Building, Rama IV, Bangkok Thailand 10330
Tel: +66 2 251 6704 | Fax: +662 251 6706 E-mail : contact@chulacrc.org


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