IQVIA Trial Manager
What is it?
The IQVIA Trial Manager is a platform integrated with the information systems supporting the execution and management of clinical studies at Research Centers, offering various features for each phase of Clinical Trials and Real-World Evidence (RWE) Studies, enabling the digitization, optimization, and automation of several processes, such as:
- Submission of studies by the sponsor or investigator
- Search for patients to include in a study cohort
- Completion of the feasibility form
- Search for investigators with the necessary profile for a study
- Economic and financial evaluation of studies
- Internal study approval process with digital signature
- Scheduling and control of visits and procedures
- Recruitment of patients from created cohorts
- Document management (e.g., consents)
- Monitoring of participant activity
- Budgeting and financial management
- Billing, expense reimbursement, and fund distribution
- KPI management through dashboards and reports
- Archive management with alerts
Value proposition
Dematerialization and digitization of clinical study management processes, considerably reducing the administrative burden and increasing the installed capacity of teams
Enhancement of RWE studies, through the creation of an electronic research process based on longitudinal data centered on patients and harmonized in OMOP
Greater cost control, allowing for the tracking of all anticipated and unanticipated visits and expenses of participants
Interoperability with information systems to centralize relevant information for the studies and avoid duplication of records
Compliance with international standards and regulations, including the Data Protection Act, the General Data Protection Regulation (GDPR), ICH Good Clinical Practices (GCP), 21 CFR Part 11, HITRUST, the ISO 27000 family, COBIT, HIPAA, HITECH, NIST, among others