Quality Assurance
We identify risks and vulnerabilities before they become problems.
To ensure the highest standards of quality and compliance across all ERG clinical trial sites, our centralized quality assurance oversight works independently of our operations team. You can be confident that every requirement is met. Every time.
Delivering Consistent High Quality Across Our Clinical Sites
ERG shares standard operating procedures (SOPs), standardized systems, and best practices across all our sites, to deliver consistently clean data. Executive management oversees all activities; internal committees meet regularly to probe options for process improvement. ERG’s centralized, standardized quality assurance procedures and policies adhere to Food and Drug Administration (FDA), International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Health and Human Services (HHS), Health Insurance Portability and Accountability Act (HIPAA) and all other applicable industry regulations.
ERG Differentiators
- Harmonized SOPS
- Constant and consistent “Under the Umbrella of Compliance” training
- Audit readiness preparation
Quality Control
Based on protocol-specific Quality Management Plans, ERG staff implement and execute quality through control checks at each site. They perform operational checks. They verify that the clinical trial’s many discrete steps are completed accurately. And they confirm that all generation, collection, analysis, and reporting of data is based on ERG’s SOPs and all the applicable regulations. Quality Control specialists also lead CAPA (Corrective Action, Preventative Action) investigations and reporting and help train site employees. That attention to detail means that data is delivered clean—and that there are no surprises.
Quality Mobile Unit
Quality Assurance team members are always available remotely to bolster local quality control efforts. But some issues require hands-on help. ERG’s Quality Mobile Unit supplies it, ready to travel to sites to implement new quality measures or assist with risk mitigation.
Dual Enrollment Verification Systems
When enrolling a clinical research trial, ERG uses various verification systems to screen for participants who may be concurrently enrolled in another trial. This protects both the patient’s health and the integrity of your trial data.
