Fundamental to any compliance strategy is the goal of successful clearance by regulatory authorities. At PMI, our commitment to quality is evident in our ISO-based Quality Management System (QMS), which requires that standard operating procedures be maintained for study–related activities.

We work with you at project initiation to clearly identify and establish processes and procedures to facilitate an efficient trial. We then integrate these procedures into customized master plans, which specify how and when the procedures will be used, and how procedural performance will be documented. These plans and procedures are formally reviewed on a regular basis and updated as necessary to accommodate changes that occur throughout the duration of your project.

(See also Quality System/ISO Certification in our ABOUT PMI section.)

PMI’s Clinical SOP Development services include:

• Project plan development/review
• Monitoring plan development/review
• Data management plan development/review
• Statistical analysis plan development/review
• Clinical study audit plan development/review
• Clinical study management/monitoring procedures development/review
• Clinical study management/monitoring activities checklist development/review
• Data management procedures development/review
• Data management activities checklist development/review
• Clinical study document templates development/review
• Clinical study inspection/audit procedures development/review