Clinical Development

Clinical Development

Clinical development

  • Preliminary evaluations of investigational sites
  • Preliminary evaluations of investigators
  • Development of clinical trial protocol (draft), case report form sample (draft), and informed consent form (draft)
  • Request to investigational sites for a clinical trial and arrangement for contract signing
  • Preparation of documents to be submitted to institutional review boards (IRBs).
  • Dispensation and collection of study drugs

Tasks related to monitoring

  • Development of monitoring report
  • Confirmation of compliance with protocol, Good Clinical Practice (GCP), and related items
  • Response to an adverse event
  • Acquisition of essential documents from investigational sites
  • Validation of case report forms referring to source documents
  • Collection of case report forms
  • Administration for closing a clinical trial
  • Inspection and quality control of case report forms

Data management/statistical analysis (Biometrics Department)

  • Database design
  • Data input and fixed services
  • Development of statistical analysis plan
  • Development of statistical analysis report
  • Development of clinical trial data lists and graphs

Medical writing (Clinical Development Department)

  • Development of clinical study report (draft)
  • Development of application outline (draft)

Operational arrangement for clinical trials

Operational arrangement for clinical trials