Patient safety is critical in clinical trials.
- Medical Input into Study Documents: Our Medical Monitors provide valuable medical input during the development of key study documents, such as protocols and informed consent forms. Their expertise helps to ensure that these documents accurately reflect the medical considerations and requirements of the trial.
- Assessment of Subject Eligibility: Our Medical Monitors play a crucial role in evaluating subject eligibility for participation in the study. They carefully review available medical records, lab results, and other relevant information to ensure that subjects meet the necessary criteria for inclusion.
- Guidance on Medical Issues: Throughout the study, our Medical Monitors provide ongoing support and guidance on medical issues that may arise. They offer expert advice and recommendations to address any medical challenges encountered during the trial.
- Review of Subject Safety Data: Our Medical Monitors meticulously review and assess subject safety data, including Adverse Events, laboratory results, and other relevant information. This thorough analysis helps to identify any potential safety concerns and ensures the well-being of study participants.
- Participation in Safety Review Committees: Our Medical Monitors actively participate in Safety Review Committees and Data Safety Monitoring Boards (DSMBs) as needed. Their medical expertise contributes to the comprehensive evaluation of study data and the formulation of appropriate safety measures.
- Review and Assessment of Serious Adverse Events: Our Medical Monitors closely review and assess serious adverse events (SAEs) reported during the study. They provide an expert evaluation of the events, considering their medical significance and potential impact on subject safety.
At Lotus Clinical Research, we are committed to maintaining the highest standards of participant safety throughout our trials. By leveraging the expertise of our Medical Monitors, we ensure that our sponsors receive comprehensive medical oversight and guidance, contributing to the successful and ethical execution of clinical research.