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: 35
- SOP on General Features of SOPs
- Safety Reporting SOP
- Patient Information Sheet /
Informed Consent Form Preparation and Procedures SOP - Non drug Supplies Management SOP
- Handling of Suspected Fraud in Clinical Trials SOP
- Protocol Writing SOP
- Medical Writing SOP
- Translation SOP
- Computer SOP
- Company Task Management SOP
- Archive SOP
- Audit Inspection Preparation SOP
- Site Selection SOP
- Monitoring Visit SOP
- Investigational Product Management SOP
- Data Management SOP
- CRF Design SOP
- Ethics Committee Submission SOP
- Patient Recruitment and Retention SOP
- Collaborating with Partners SOP
- Meeting Organization SOP
- Emergency Management &Disaster Recovery SOP
- Quality Control and Assurance SOP
- Documentation SOP
- Training SOP
- Site Management Organization SOP
- Laboratory and Medical Center Organization SOP
- Post-Marketing Surveillance Studies SOP
- Project Management SOP
- Database Life Cycle SOP
- Electronic Data Capture SOP
- Import Licence and Customs Clearance Procedures SOP
- Risk Management SOP
- Corrective and Preventive Action Plan
- Product and Patient Tracking Systems SOP