24-hour safety service.

Lotus Clinical Research’s team of experienced physicians and nurses is dedicated to providing a support network for our subjects. In order to provide this level of support, Lotus Clinical Research provides a 24-hour safety service for our clinical trials. Analgesic trials provide a unique challenge because subjects who are enrolled generally have significant ongoing pathology (chronic disease states in the case of chronic pain trials and postsurgical morbidity in the case of acute pain trials). The medical monitors at Lotus Clinical Research are familiar with the natural pathophysiology of patients who enroll in analgesic trials, improving their ability to accurately survey these studies.

Ensuring the safety of the subjects who participate in our trials is paramount at Lotus Clinical Research.  Lotus Clinical Research provides our sponsors with therapeutically aligned medical professionals to serve as Medical Monitors.  Some of the services that our Medical Monitors provide to our sponsors include:

  • Medical input into key study documents such as protocols and informed consent forms
  • Assessment of subject eligibility 
  • Input into medical issues encountered during the study
  • Review of subject safety data such as Adverse Events, laboratory data, etc.
  • Participation in Safety Review Committees, DSMBs, etc.
  • Review and assessment of serious adverse events