White Paper

Conducting Research With CAR T Cells

Conducting Research With CAR T Cells Regulatory and Practical Considerations Having proven successful in trials…

White Paper

4 KPIs Clinical Research Study Managers Can Master

This white paper examines four KPIs most impacting timelines and budgets and offers strategies for…

White Paper

CAR T Manufacturing and Toxicity

CAR T Manufacturing and Toxicity Pre-Clinical Considerations Genetically engineered therapeutics present diverse, and sometimes heightened,…

White Paper

sIRB Review for Multicenter Research: A Guide for Institutions

Prepare for single IRB review with insights on reliance agreements, communication plans, lead site responsibilities,…

White Paper

Operationalizing Research Analytics: Today, Tomorrow, Someday

Discover how AI and analytics are transforming clinical trial operations, from study startup to accrual…

White Paper

GxP Compliance in Clinical Research

Explore GxP principles in clinical research, from ensuring safety and integrity to regulatory adherence, with…

White Paper

4 Modernized Functions Every Sponsor Needs for Study Startup

Efficient study startup relies on modern tools, including standardized documentation and real-time dashboards, to minimize…

White Paper

Navigating Key Complexities in the Development of Cell and Gene Therapies

Discover how biotech organizations navigate the unique challenges of cell and gene therapies, from regulatory…

White Paper

Data on the go: Mobile Application Considerations for Clinical Trials and Beyond

Explore regulatory and ethical considerations for mobile apps in clinical trials, from device regulations to…

White Paper

Unique First-in-Human Phase I IRB Considerations you Might not Know About

Explore unique IRB considerations for first-in-human Phase I trials, from informed consent to participant protections…

White Paper

Understanding how to Build and Leverage a DSMB Statistical Plan

Discover the DSMB statistician’s critical role in safety monitoring, including SAPs, validated programming, and study…

White Paper

Rare and Orphan Diseases: Choosing a Path to Regulatory Approval and Market Success

Explore regulatory pathways and strategies for bringing rare disease therapies to market, addressing challenges in…

White Paper

What Does an Endpoint Adjudication Committee (EAC) Do?

Learn how Endpoint Adjudication Committees ensure safe study conduct, mitigate participant risks, and provide unbiased…

White Paper

Establishing and Operating a DSMB: Tips for Clinical Trial Success

Learn how DSMBs safeguard trial integrity and participant safety with insights on setup, member selection,…

White Paper

Planning Organizational Design for Clinical Development Organizations (CDOs)

Discover how CDOs can balance productivity and quality by exploring agile approaches, benchmarking insights, and…

White Paper

Expedite Study Startup: Four Strategies to Optimize Site Activation

Learn how organizations can expedite study startup and avoid delays through streamlining site selection, training,…

White Paper

The Rise of the Clinical Research Network: Using Technology to Connect Sites and Sponsors

Explore how integrated technology solutions can reduce inefficiencies, improve diversity, and streamline workflows in clinical…

White Paper

Planned Emergency Research and Exception from Informed Consent

Explore the regulatory criteria and ethical considerations for planned emergency research, including exceptions from informed…

White Paper

Ensuring Success with Clinical Development Planning

This white paper outlines key elements of a CDP, including Treatment population, Demonstration of efficacy,…

White Paper

The Clinical Development Plan: Executing the Clinical Strategy

This white paper outlines key elements of a CDP, including Treatment population, Demonstration of efficacy,…

White Paper

Reporting to the IRB: What Does and Does Not Need to be Reported

Learn the essentials of IRB reporting, including why it matters, what’s required, what’s not, and…

White Paper

The ROI of Site-Centric Training and Support

Adopting a site-centric mindset benefits sponsors and CROs by addressing site challenges, leading to faster…

White Paper

Enabling Compliant Remote Data Capture and Document Management

Explore strategies for compliant remote data capture and document management, ensuring effective support for decentralized…

White Paper

Ethical Issues in the Design and Review of Decentralized Research

Learn how to navigate ethical issues in decentralized research with insights for sponsors and IRBs…

White Paper

Steps to Implementing a Quality Management System

Steps to Implementing a Quality Management System Making quality not just an expectation, but an…

White Paper

End-to-End Approach to Clinical Development

This white paper promotes an end-to-end approach through discussing Organizational design, Team structure, Process design,…

White Paper

Understanding the Current and Future States of Cell and Gene Therapy Research

Explore the current and future landscape of gene therapy research, from advancements in oncology to…

White Paper

Vendor Management and Oversight of Clinical Trials

Discover practical guidance on vendor management, including vendor selection, risk assessment, and oversight to ensure…

White Paper

Site Technology Guide for Facilitating GCP in Decentralized Trials

Explore GCP considerations for decentralized trials and discover how secure site technology can streamline oversight…

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Developing a Data Strategy for Clinical Trials

This white paper outlines a data strategy specific to an organization’s unique needs and allows…

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Want to see the latest news and updates about Advarra? You can find them in the Newsroom

White Paper

Conducting Research With CAR T Cells

4 KPIs Clinical Research Study Managers Can Master

CAR T Manufacturing and Toxicity

sIRB Review for Multicenter Research: A Guide for Institutions

Operationalizing Research Analytics: Today, Tomorrow, Someday

GxP Compliance in Clinical Research

4 Modernized Functions Every Sponsor Needs for Study Startup

Navigating Key Complexities in the Development of Cell and Gene Therapies

Data on the go: Mobile Application Considerations for Clinical Trials and Beyond

Unique First-in-Human Phase I IRB Considerations you Might not Know About

Understanding how to Build and Leverage a DSMB Statistical Plan

Rare and Orphan Diseases: Choosing a Path to Regulatory Approval and Market Success

What Does an Endpoint Adjudication Committee (EAC) Do?

Establishing and Operating a DSMB: Tips for Clinical Trial Success

Planning Organizational Design for Clinical Development Organizations (CDOs)

Expedite Study Startup: Four Strategies to Optimize Site Activation

The Rise of the Clinical Research Network: Using Technology to Connect Sites and Sponsors

Planned Emergency Research and Exception from Informed Consent

Ensuring Success with Clinical Development Planning

The Clinical Development Plan: Executing the Clinical Strategy

Reporting to the IRB: What Does and Does Not Need to be Reported

The ROI of Site-Centric Training and Support

Enabling Compliant Remote Data Capture and Document Management

Ethical Issues in the Design and Review of Decentralized Research

Steps to Implementing a Quality Management System

End-to-End Approach to Clinical Development

Understanding the Current and Future States of Cell and Gene Therapy Research

Vendor Management and Oversight of Clinical Trials

Site Technology Guide for Facilitating GCP in Decentralized Trials

Developing a Data Strategy for Clinical Trials

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