We have an organized Data Review Committee; an independent non-biased panel and taking care of patient safety through periodically review of the clinical study data.
Based on the interim efficacy result and safety aspects, Data review committee can give suggestion on the following points for the study conduct, but not limited to:
· Whether to continue, modify or terminate the clinical study or not.
· Modification in the sample size
· Add on safety measures
· Modification in end point
We ensure for the critical safety, medical, and scientific insights of the clinical study and its quality perspective through our comprehensive medical monitoring.
Our main focus is to ensure patient safety and management as well as the quality and integrity of the study data as per the study design. Ensuring the safeguard of the patients with the requirements of a clinical trial protocol and study plan is the key to the success of a study and meeting its intended objectives. We continuously oversee the safety data of individual patient as well as of the group throughout the entire study.
So, it is very essential to have an oversight throughout the study design, study plan, study conduct and reporting of safety details for a clinical and medical aspects by an expertise team and provide guidance on every aspect. We help in preparing a detailed safety management plan which is required for the safety management planning.
We have a team of experts who provide various strategies for the clinical conduct and preparation, review, and assessment of study documents including the eligibility of clinical trial participants, unblinding procedure, and safety information – SAE and SUSAR forms and pregnancy form; from initiation to end of the study.
HaleUS
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