WATCHING OVER YOU

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.

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​