How Technology Can Improve Regulatory Efficiencies During the COVID-19 Pandemic and Beyond
Sites and life sciences companies have quickly adopted remote workflows to keep trials moving, and these changes are sure to inform our “new normal” as we look forward.
How Technology and System Integration Can Improve Your Billing Compliance
The consequences of inaccurate billing can be severe, and ensuring workflows are being followed by all teams across an institution can be a difficult process.
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.
Above & Beyond: Better Utilize In-House Reporting Resources with Advarra Insights
Does your organization utilize your in-house reporting teams and systems to their full potential? Learn how a standardized business intelligence system could complement your current reporting structure to improve your organization’s operations.
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.
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?
How Staff Augmentation Assists with Successful Data Migration
With the goal to move active data from one system into OnCore CTMS, Advarra’s Staff Augmentation team worked with a customer’s associated hospital as it was faced with software termination.
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.
Informed Consent: When, Why, and How It’s Obtained
Aside from being a regulatory and ethical requirement, informed consent is a good way to ensure participant knowledge and develop a foundation trust between researcher and participant.