How Technology Can Improve Regulatory Efficiencies During the COVID-19 Pandemic and Beyond
As we begin to emerge from the challenges of the COVID-19 pandemic, it’s clear that the post-pandemic landscape differs from...
How Technology and System Integration Can Improve Your Billing Compliance
Billing compliance is one of the most important and complicated processes researchers deal with on a day-to-day basis. The consequences...
Facilitating Compliant Billing Using the OnCore Enterprise Research System
For academic institutions managing a large volume of clinical research protocols, the key to compliant billing is an accurate and efficient exchange of information. In this webinar, we will discuss best practices for compliant billing and show how a clinical trial management system (CTMS) can help centralize your billing designation.
FDA Inspection Readiness: After the Inspection
Preparing for an FDA inspection and enabling a site-specific process to support it is important. Learn more about what to expect and implement after an FDA inspection is completed at your institution.
FDA Inspection Readiness: During an Inspection
Preparing for an FDA inspection and enabling a site-specific process to support it is important. Learn more about what to know while undergoing an FDA inspection at your institution.
GCP Assessment During COVID – “Did Your Clinical Trials Remain GCP Compliant During COVID-19?”
Almost a year into the COVID-19 pandemic, analyze how IRB submissions, informed consent, and remote monitoring practices have maintained GCP compliance.
FDA Inspection Readiness: Preparing for an Inspection
Preparing for an FDA inspection and having a site-specific process for supporting a regulatory inspection is important. Learn more about how to prepare for an FDA inspection.
Efficiently Implement and Validate your Advarra eReg or EDC Instance
4 Reasons Your Institution Needs an eRegulatory System
Using physical binders or an internal shared drive can slow research operations. Implementing an eRegulatory system helps institutions streamline research by transforming key workflows.
Strengthening Trial Enrollment Through Pre-Screening
How Sites Can Win in the New Age of Genetically Engineered Treatments
The accelerating gene therapy market is expected to grow 16.6 percent by 2027. As gene therapies enter the pipeline, how can sites prepare themselves to take advantage of the rush?
Key Considerations for Regulatory Compliant Document Storage
It is imperative that your organization has a reliable eRegulatory system and associated policies for storage and upkeep of clinical trial documents to ensure 21 CFR Part 11 compliance. Read our Key Considerations for Regulatory Compliant Document Storage.