STUDY SITE MANAGEMENT

Our site support services are to ensure the study quality and accuracy of research data in order to meet the global studies.

  • Preparation and provision of site information related to clinical trials in order to meet the feasibility evaluation by Sponsors and clinical trial submission;
  • Support in generating essential forms and templates for clinical trials, if needed;
  • Support in writing Standard of Procedures (SOPs);
  • Support in obtaining Informed Consent (IC);
  • Support in the process of selecting and screening patients;
  • Support PI in entering Case Report Form/electronic Case Report Form (CRF/eCRF);
  • Support in archiving and managing all sources of data, as well as all records and related documents;
  • Support in conducting the trials in compliance with relevant protocols, SOPs and GCP (e.g., supervising and instructing all procedures to ensure the proper implementation, thereof);
  • Support in reviewing and updating information for required documents/ files (e.g., updating investigator files, and patient binders);
  • Support in following-up with patients (e.g., setting and reminding patients of visit schedules);
  • Support in reporting Adverse Events / Serious Adverse Events (AEs/SAEs) and completing other medical reports;
  • Preparation of essential documents/files to meet the monitoring and auditing requirements;
  • Support in establishing and managing clinical offices;
  • Support in managing investigational products;
  • Support in activities related to IRB operations;
  • Support in training the study team at clinical sites;
  • Other support requested by the Principal Investigator (PI).
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