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Reach out to our team of experts to discuss your project needs.
Medical Monitoring
Extensive scientific and medical background to support each study.
Clinical Trial Design Support and Medical Planning
Based on:
- thorough discussion with the sponsor,
- professional experience and
- proficient familiarization with all relevant data,
experienced medical monitors provide expert medical review and input to:
- study protocols,
- investigator brochures, and
- develop customized medical monitoring plans.
Medical Oversight of Clinical Trials
Allocated medical monitor maintains comprehensive surveillance over the course of the clinical trial. SanaClis’ seasoned professionals with wide-ranging medical expertise perform ongoing thorough reviews of relevant medical data, evaluate and promptly address any abnormal outcomes to maintain safety of subjects in clinical trials. Medical monitors actively collaborate with the project team and support protocol deviation assessments.
Assessment of Subject Eligibility for Randomization
Thorough subject specific eligibility assessment for randomization is performed based on protocol criteria to minimize the risks of incorrect randomizations and administration of study drug to study subjects that could be harmed by the IMP or procedure used. This step also safeguards the integrity of study data and outcomes.
Ongoing Medical Advisory Support
Our medical specialists offer tailored guidance to sites, sponsors, and collaborators on all clinical aspects of the project. Upon request, enhanced availability, including 24/7 support, can be arranged to assist sites in promptly addressing medical concerns and mitigating risks of serious health deterioration or potential severe drug-related reactions in study participants.
Medical monitors may also participate in investigator meetings, site initiation visits, or ad hoc training calls to ensure consistent medical understanding and proper trial execution at the site level.
Management of the Data Safety Evaluation Activities
SanaClis Medical Affairs provides expert support or lead data safety evaluation assemblies such as Data Safety Monitoring Boards (DSMB), Dose Escalation Meetings, and other safety review processes on behalf of the Sponsor, ensuring informed and timely decision-making throughout the study.
Additionally, our team is available to support regulatory inspections or audits when medically relevant oversight, documentation, or decision-making is being evaluated.
