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
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