equilan clinical activities

Clinical Research Activities

Our scopes of activities in clinical trial include:

1. Study Initiation (development and arrangement)

  • Scientific input in pre-study consultancy
  • Protocol development and review
  • Case Report Forms (CRFs) development
  • Development and review of subject information, informed consent and other supporting documents for clinical studies implementation e.g. : symptoms score questionnaire, patient’s diary, study checklist/log/form, etc.
  • Investigator/Clinical site selection and set up
  • Central labs identification and evaluation
  • Documents preparation and submission to meet regulatory, GCP, and SOP requirements
  • Study budgeting and grant payment schedules assistance
  • Investigator meeting arrangement

2. Study Conduct (coordinating and monitoring)

  • Site and centered Investigators meeting conduct
  • Remuneration management: Institution fee, Investigator fee, and Subject fee
  • Logistic Management: study drug, biological sample and document handling
  • Study Monitoring
  • Initiation and monitoring visit
  • Maintenance and study data tracking (patient enrollment, CRF collection, study checklists/log/form, etc
  • Source data and document verification
  • Adverse events and serious adverse events monitoring and reporting
  • Monthly monitoring report
  • Data queries resolution
  • Study close out
  • Conduct study close out visits
  • Perform post-study follow-ups

3. Laboratory test

  • Clinical laboratory test
  • Bioanalytical laboratory test including: therapeutic drug monitoring, pharmacokinetic and BA/BE Study

4. Data Management

  • Data collection, storage and entry
  • Statistical analysis
  • Final report
  • Archive study files

5. Quality Assurance

  • Conduct clinical sites audits

6. Post-study service

  • Publication
  • Provide scientific information during drug registration process and marketing-related activities.