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.