Pitfalls of Chemistry, Manufacturing, and Controls in Investigational New Drug Preparation
Developing an investigational new drug (IND) application is a big milestone for organizations, especially small companies bringing their first drug
CRO
Building a Foundation for Regulatory Success in the Post-Pandemic Landscape
The past year has been one of the most challenging ever for those working in healthcare and clinical research. The
Study Startup Success for BioPharma and MedTech: Engage a Research Compliance Partner
A key element to successful study startup is identifying efficiencies to help meet critical milestones. Engaging with research compliance experts
3 Strategies to Successfully Engage Participants in Your Trial
Engaging participants and creating a positive experience throughout your clinical trial increases protocol compliance, participant retention, and referrals.
Understanding the Complexity and Uniqueness of Phase I Trials
In clinical research, working with organizations that understand the ins and outs of the phase of your trial is key
mRNA and Its Role in Clinical Research
In the race to address the COVID-19 pandemic, researchers have worked tirelessly the past year to produce a vaccine. Operation
Does Warp Speed Vaccine Development and Testing Compromise Safety?
A common trope in sci-fi movies involves concerns about potentially smashing into uncharted objects while traveling at warp speed or
Top 10 Educational Resources of 2020
It’s safe to say 2020 has been more unpredictable than anyone could imagine. Through these unprecedented times, we have worked to provide the
New FDA Certificate of Confidentiality Guidance: What Does it Mean for You?
FDA has recently issued guidance relating to changes for Certificates of Confidentiality (CoCs) brought about by the 21st Century Cures
The Many Faces of “Coercion” and “Undue Influence”
The United States regulations governing research with humans pay special attention to two ethical concepts that may not be familiar
Q&A – Racial Diversity in Clinical Trials: Building Trust in Participant Engagement
In our latest webinar, a panel of experts from research organizations, Community Health Centers (CHCs) and healthcare tech discussed racial
Takeaways From the FDA’s VRBPAC Meeting – October 22, 2020
As part of FDA’s response to combat COVID-19, FDA convened its Vaccines and Related Biological Products Advisory Committee (VRBPAC). The