Products & Services

Contract Monitoring and Study Management;

  • HIPAA Compliant Clinical Trial Operations Model;
  • eClinTMS a Trial Management System;
  • Study specific monitoring plan and report development;
  • Regulatory document collection and tracking;
  • eClinLMS a Learning Management System;
  • Standardized documents (informed consents, authorization forms, source document templates);
  • Investigator recruitment;
  • Development of SOPs for Sponsors, CROs, and Sites in the areas of managing, monitoring, and coordinating clinical trials;
  • Study material development including a Site Study Binder with GCP Educational Action Plans;
  • Quality improvement; and
  • Regulatory consultation.

Clinical Trial Design and Development

  • Reviewing and writing protocols;
  • Case report form design;
  • Quality improvement; and
  • Regulatory consultation.

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