Audit-Ready Data
Our investment in data integrity starts with our experts. They understand data management and root cause analysis, quality measure implementation and good clinical practice, because they have decades of experience with FDA and sponsor audits. And they pride themselves on the data being clean.
30%
staff allocated to QC
We have three keys to a clean audit
Quality Control
- Protocol-specific data integrity plans
- Overnight QC of 100% of patient visits
- Automated exception reporting
- Ongoing internal audits
Quality Assurance
- Pre-built edit checks against protocol standards
- Informed consent reviewed in near-real time
- Pre-randomization eligibility review
- Near-real-time exception reporting
Regulatory
- Centralized regulatory document management
- Dedicated regulatory manager for network-wide study maintenance
- Real-time informed consent review by independent QC specialist
- Informed consent, patient consent and reconsent
Centralized data management leads to swift identification
of trends across AE/SAE data.
of trends across AE/SAE data.
Data integrity is built into our operations
Data integrity requires far more than a strong set of standard operating procedures (SOPs). It demands protocol experts who work closely with all clinical operations departments throughout a study, from start-up to close out. At Alliance Clinical, our quality team partners with staff on all document preparation and completion. They verify informed consent forms, medical histories, treatment histories, eligibility criteria, adverse event reports, primary outcome measures and institutional review board documents. They manage preparation for site monitoring visits, FDA audits, Sponsor audits. They even develop training programs for investigators and clinical research coordinators. Because without data integrity, the trial is meaningless.
Purpose-built to accelerate clinical trials. See how.
Carefully crafted strategies speed time to FPI and keep enrollment high. Learn more.
