Review and Assessment

Customers requesting a complete review and assessment of effective Standard Operating Procedures (SOPs) are provided with feedback to ensure:

• Existing SOPs are sufficient and relevant to current operational practices and current and pending regulations.
• Major flaws or gaps in current practices, workflow, operations, and documentation are corrected.
• Confirmation that personnel have the procedures and training to conduct a clinical trial in a controlled environment.
• Training requirements are developed to accurately reflect the local regulations.

Authoring

Standard Operating Procedures can be authored for:

• All activities where legal or regulatory requirements must be observed.
• A uniformity of practice is desirable.
• Operational controls must ensure that essential steps are taken in proper sequence and will provide specific direction for internal clinical trial personnel.