
ENSURING SAFETY
MEDICAL MANAGEMENT
CurAccel’s Medical Management team are composed of clinical professional with industry experience to provide you a rich experience of in-depth therapeutic expertise and strategic counsel. Integrated into our Medical Monitoring is a Pharmacovigilance service that can support your safety monitoring and reporting requirements.
CurAccel can operate as a functional service provider or as a standalone provider. At a minimum, our Medical Monitoring service offerings are:
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Investigator brochure and IMPD development support and clinical review
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Study design & protocol development
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Therapeutic area consulting
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Medical Interactions with Competent Authorities
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Medical monitoring plans
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24-hour beeper on-call medical monitoring for protocol queries and site support, eligibility/medical/safety issues
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Data Monitoring Committee support
At a minimum, our Pharmacovigilance service offerings are:
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Safety database
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SAEs/SUSARs monitoring
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Patient narratives
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Annual safety reports and DSURs
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Interim safety listings
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SAEs reconciliation
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Participation in the Safety Advisory Board