At PMI, we think that research compliance is the result of
a combination of factors: well-designed protocols and data
capture forms; appropriate clinical standard operating procedures;
effective site training and monitoring; and periodic project
audits. While we maintain our own ISO certified Quality Management
System, we work with you to develop and implement compliance
strategies specific to your study and oriented toward the
successful clearance of clinical study inspections by regulatory
authorities.
Our commitment to compliance begins with project teams comprised
of individuals who are experienced with the application of
Good Clinical Practices (GCP). We support our teams with relevant
clinical study procedures, guidance with respect to GCP expectations,
and detailed checklists and logs to facilitate appropriate
performance of study–related activities. Early in each
project, we begin training, and we monitor and continue to
train throughout your study.
Our Research Compliance services include:
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