MEDICAL MONITORING FOR CLINICAL TRIALS

MEDICAL MONITORING SERVICE FOR ONCOLOGY & CARDIOVASCULAR STUDIES

EXPERIENCE | PROFESSIONALISM | CLINICAL AND LEGAL EXPERTISE

Ensuring subject/patient safety and compliance with the requirements of a clinical trial protocol are paramount to the success of a study meeting its intended objectives. Therefore, it is critical to have experienced clinical and medical oversight throughout the design, execution and reporting throughout all phases of a clinical program. Our experienced Medical Monitors are available to provide strategic drug development guidance, as well as to review key study documents and safety information and act as the lead medical resource to support the investigators and sites involved in the study.

Our medical monitoring services include

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Medical review of study protocol

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Study team support to define and qualify the inclusion/exclusion criteria

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Phone support to answer questions regarding safety and enrollment/eligibility

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Supporting investigational sites, site monitors or project management on any medical issues or questions related to safety

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Maintaining medical monitoring logs to ensure consistent guidance

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Reviewing medically related protocol violations, including escalation according to predefined criteria

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Medical support to signal detection activities

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Independent medical monitoring for safety review meetings and participation in Independent Data Monitoring Committee (IDMC) and Data Safety Monitoring Board (DSMB)

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Review and approval of MedDRA and ATC code

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Medical reviews of all safety data, including AEs and SAEs reported in the clinical and safety database

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Medical review of potential endpoints

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Medical review of patient narratives / profiles

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Medical review of lab alerts and lab, ECG and other study specific data

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Medical review of clinical study reports

Contact us now

Twiga Europe, through an highly qualified and acknowledged team of professionals an partners, delivers an uncommon service efficiency and quality. Please do not hesitate to contact us at the addresses below.