Optimum-cro :: Optimum Contract Research Organization

Opening Hours : Monday to Friday - 09am to 6pm
  Contact : (+90) (312) 231 76 46

SOPs

OPTIMUM CRO has comprehensive and detailed SOPs to guide and train all the staff, to ensure operations to be carried out in compliance with ICH/GCP & regulations and to fulfill sponsor requests and requirements.

OPTIMUM quality managers have prepared and approved the latest versions of many SOPs while a number of new SOPs have also been prepared and all these are being implemented by related staff. In addition, in OPTIMUM project management system it is always possible to work with sponsor SOPs. OPTIMUM SOPs are: 29

  • SOP on General Features of SOPs
  • Patient Information Sheet /
    Informed Consent Form Preparation and Procedures SOP
  • Safety Reporting SOP
  • CRF Design SOP
  • Audit Inspection Preparation SOP
  • Investigational Product Management SOP
  • Quality Control and Assurance SOP
  • Non drug Supplies Management SOP
  • Company Task Management SOP
  • Protocol Writing SOP
  • Translation SOP
  • Meeting Organization SOP
  • Documentation SOP
  • Ethics Committee Submission SOP
  • Project Management SOP
  • Monitoring Visit SOP
  • Data Management SOP
  • Training SOP
  • Collaborating with partners SOP
  • Patient Recruitment and Retention SOP
  • Computer SOP
  • Handling of Suspected Fraud in Clinical Trials SOP
  • Archive SOP
  • Medical Writing SOP
  • Emergency Management & Disaster Recovery SOP
  • Site Management Organization SOP
  • Laboratory and Medical Center Organization SOP
  • Post-Marketing Surveillance Studies SOP
  • Site Selection SOP