WATCHING OVER YOU

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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 in our Medical Management is Pharmacovigilance service that can support your safety monitoring and reporting requirements.

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CurAccel can operate as a functional service provider or on a standalone basis.  At a minimum, our Medical Monitoring service offerings are:

• Investigator brochure and IMPD development support and clinical review

• Study design & protocol development

• Therapeutic area consulting

• Medical interactions with Competent Authorities

• Medical monitoring plans

• 24-hour beeper on call medical monitoring for protocol queries and site support, eligibility/medical/safety issues

• Data Monitoring Committee support

 

At a minimum, our Pharmacovigilance service offerings are:

• Safety database

• SAEs/SUSARs monitoring

• Patient narratives

• Annual safety reports and DSURs

• Interim safety listings

• SAEs reconciliation

• Participation in Safety Advisory Board​

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