Research Compliance
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?
The Power of Getting Everyone in Your Clinical Trial to Work as One Team
Everyone wins when all the stakeholders of a trial work together as a team. Yet, providing this sense of camaraderie across the study ecosystem is difficult.
The Study Manager’s Guide to Cultivating Positive Site and Patient Relationships
We ask a lot of questions about what makes trials work. From speaking to clinical study sites, investigators, trial patients, and study managers, there is always a common theme: the importance of working as a team.
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.
Q&A: Institutional Responsibilities Under a Federalwide Assurance
Q&A from the Institutional Responsibilities Under a Federalwide Assurance (FWA) webinar and an overview of the FWA and its changes with the revised Common Rule.
Q&A – Regulatory Fine Points: Exploring 21 CFR Part 11 Validation
Advarra's experts answer audience questions from our Regulatory Fine Points: Exploring 21 CFR Part 11 Validation webinar.
Utilizing eRegulatory Integrations to Expedite Regulatory Workflows
Learn how key eRegulatory integrations like email, local and central IRBs, and Clinical Trial Management Systems can accelerate study start up, increase compliance, and improve regulatory workflows.
A Guide to System Integrations and Single Sign-On for Clinical Operations Teams
The growing complexity of clinical trials is being met with a new generation of eClinical tools – electronic data capture, centralized trial platforms, and risk-based management tools.
Inova Health System Uses Advarra eReg Workflows and Integrations to Improve Regulatory Efficiency
Expanding Our Global Consulting Expertise to Solve Mission-Critical Issues
Elevating our consulting capabilities to accelerate clinical research and bring therapies to market sooner.
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