Medical Monitoring

Oversight by medical experts is an essential aspect of clinical trials, both for therapeutic insights and to prioritize the best interests of study participants. Our skilled physicians and health care professionals provide medical monitoring services, offering continuous oversight of the clinical study’s medical aspects and assistance to the project team, both in-house and at sites.

To facilitate discussion and decision-making on medical aspects of the trial, these experts provide medical advice to sponsors, project teams, and study sites. They act as the key contact for principal investigators (PIs), sponsors, and project teams. Our medical monitors work collaboratively with colleagues in data management and biostatistics to share knowledge on behalf of our clients. This teamwork ensures a quick turnaround of data review, which is vital to being prepared for Data Review Committees. Our medical experts have deep experience in all phases of clinical trials and are proficient in adaptive trial design.

In addition, Allucent provides:

• Medical strategy and assistance in protocol and other documentation
• Study optimization strategies, including patient recruitment approaches
• Identification of study risks and appropriate mitigation strategies
• 24/7 medical coverage for eligibility assessment, emergency un-blinding, and/or general study support
• Oversight of the safety of study participants, medical review of adverse events, safety listings, and interim/final trial reports, in collaboration with our pharmacovigilance group
• Periodic assessment and evaluation of the progress, safety data, protocol deviations, and critical endpoints
• Facilitation of Data Review Committees (Data Monitoring Committee/Data Safety Monitoring Board and Clinical Event Adjudication) and when appropriate, efficacy and dose escalation decisions and participation at dose escalation meetings