ethica provides a complete range of study management services, either as a comprehensive package at the inception of your study, or on a selective basis during an ongoing study when additional resources and services are required.
Our full-service clinical monitoring is conducted in accordance with the study protocol, ICH-GCP Guidelines and applicable regulatory requirements including -
- Pre-study document collection and review
- Site selection
- Pre-study site visits
- Initiation visits
- Monitoring visits
- 100% source document review and data verification, quality control reviews, drug storage/ accountability, data verification and query resolution
- Close-out visits
- Project tracking and monitoring reports.
Other high-level managerial services include -
- Negotiation and administration of Investigator grants
- Clinical trial insurance negotiation and procurement
- cGMP labeling, packaging, distribution, coordination and tracking of clinical trial materials
- IRB/REB coordination and submissions
- Regulatory document processing and tracking
- Central laboratory selection and coordination
- Study-specific clinical personnel training programs for Investigators and Coordinators
- High-quality, professional Investigator meetings
- Site- and/or study-specific participant recruitment strategies and programs including contingency strategies and solutions to address specific project challenges
- Development of all study related documents and materials including study protocols, amendments, CRFs (paper or electronic), informed consent forms, study operations/monitoring manuals in accordance with data management conventions
- Web-based data listings including adverse events, enrollment status, efficacy endpoints, study newsletters (paper or electronic) on our secure website
- Development and management of tracking tools for enrollment, essential documents, monitoring, participant and CRF tracking, drug accountability, data queries, adverse events
- Development of study-specific SOPs.