Medical monitoring ensures the smooth running of your clinical trial. We provide medical monitoring and tailored support to our clients, investigational sites and study teams with qualified, experienced drug safety physicians, with broad therapeutic experience.
Why choose SGS medical monitoring?
We offer you:
- Medical support and close collaboration with our biometrics teams to ensure high-quality data and on-time reporting of study deliverables
- Tailored medical monitoring according to your specifications and study requirements
- Customized medical support, resulting in reduced client oversight
- A quality approach which avoids protocol deviations related to medical concerns
World-class medical monitoring from a trusted provider
We offer you unrivaled expertise in medical monitoring.
Clear procedures and close interaction of our medical monitoring team with the different study teams support timely eligibilities evaluations, and ensure a smooth patient recruitment and safety follow-up during your study.
Our medical monitoring services include:
- Medical review of study protocol
- Study team support to define and qualify the inclusion / exclusion criteria
- Phone support to answer questions regarding safety and enrollment / eligibility
- Supporting investigational sites, site monitors or project management on any medical issues or questions related to safety
- Maintaining medical monitoring logs to ensure consistent guidance
- Reviewing medically related protocol violations, including escalation according to predefined criteria
- Medical support to signal detection activities
- Independent medical monitoring for safety review meetings and participation in Independent Data Monitoring Committee (IDMC) and Data Safety Monitoring Board (DSMB)
We also provide close interaction with our biometrics department for the support of:
- Medical reviews of all safety data, including AEs and SAEs reported in the clinical and safety database
- Review and approval of MedDRA and ATC code
- Medical review of lab alerts and lab, ECG and other study specific data
- Medical review of potential endpoints
- Medical review of patient narratives / profiles
- Medical review of clinical study reports
To discuss your medical monitoring requirements, contact us today.