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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:

  • 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 the Safety Advisory Board​

Phone: 877 757 3393

Fax: 877-567-1047

CurAccel, LLC

12 Penns Trail  Suite 202 Newtown, PA 18940

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