Regulatory Pathways: When to Submit a 505(b)(2) or an ANDA
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
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5 Questions to Ask Your Sponsor for DCT Implementation
The pandemic proved decentralized clinical trials (DCTs) can reduce patient burden while delivering quality data in a streamlined environment. In
Regulatory Considerations for Pharmaceutical Product Lifecycle Management
As a pharmaceutical product makes its way through the lifecycle, there are often Food and Drug Administration (FDA) guidelines organizations
Q&A: The IND Journey Phase I – Navigating Success
Advarra experts Sharon Ayd and Leslie Paul answer questions from their webinar, The IND Journey Phase I – Navigating Success.
The Revolving Door of Research: The Resourceful Way to Run Trials
Learn how flexibility, location, and virtual tech are redefining research work in this eBook on the “revolving door” of industry resources.
Developing an Enterprise Roadmap to Post Authorization Safety Studies
Discover how a top 10 biopharma company partnered with Advarra Consulting to implement and manage compliant post-authorization safety studies (PASS).
Top Barriers to Participation in Clinical Trials
Recruiting study participants is one of the most challenging tasks in the clinical trial process, and arguably one of the
Common Pitfalls in Preparing an IND Application
As a drug successfully makes it through the development process, sponsors will inevitably need to submit a new drug application
Patient Recruitment and Enrollment in Clinical Trials
For many clinical research staff members, recruiting participants for a study poses a challenge – sometimes a bigger challenge than
4 Questions to Ask When Establishing a Pharmacovigilance Organization
Establishing a compliant pharmacovigilance (PV) function from scratch is often an overwhelming exercise for emerging biotech organizations, typically competing with
A Checklist for Optimizing Clinical Trial Study Startup Activities
From protocol design to site training, optimizing study startup requires meticulous planning and collaboration to ensure timely trial activation.
Best Practices in Pre-Screening Includes Use of Technology
Pre-screening subjects is common practice at most sites. In this article, learn some best practices and how technology can play an important role.