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Case Study

Strengthening Trial Enrollment Through Pre-Screening

February 8, 2021

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Blog

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?

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6 min. read
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E-Book

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.

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E-Book

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.

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Blog

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.

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5 min. read
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Blog

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.

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4 min. read
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Case Study

Helping to Ensure the Success of a Phase III Vaccine Trial

January 24, 2021

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Blog

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.

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7 min. read
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Blog

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.

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5 min. read
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Blog

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.

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4 min. read
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E-Book

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.

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Case Study

Inova Health System Uses Advarra eReg Workflows and Integrations to Improve Regulatory Efficiency

January 11, 2021

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