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Clinical Evaluation LLC

Preparation and medical review of protocols

• Our staff has experience in the preparation and the medical review of clinical trial protocols for sponsors.

• We can aid in developing subject/patient eligibility for trials.

• Study reliability and efficiency can be improved by careful analyses of components of inclusion and exclusion criteria such as electrocardiography (ECG) and computerized algorithmic ECG interpretation, specialized components of the physical examination (e.g., mental status), relevant aspects of medical history, and required laboratory testing.

• We have expertise in reviewing and modifying protocols to improve study effectiveness and efficiency, and reduce costs. Areas of consultation include but are not limited to:

  • preparation of study Source Documents;
  • the operationalization and timing of protocol-mandated interventions;
  • appropriate use of telemetry;
  • the implementation and interpretation of protocol-mandated tests;
  • determination of the clinical significance of abnormal findings on laboratory and electrocardiographic testing;
  • advice regarding the appropriate implementation of FDA guidance on Q-T interval measures.