Top 3 Reasons Why Your Medical Device Needs a Clinical Trial
Interpreting evolving regulations for medical devices is a common challenge for emerging biotech companies.
FDA Guidance Offers New Flexibility to Biotechs in Cell and Gene Therapy
FDA recently released new guidance, potentially impacting early-phase cell and gene therapy trials.
Top Barriers to Participation in Clinical Trials
Understanding the factors that influence the decision to participate in a study helps research professionals diagnose enrollment problems.
Clinical Trial Superheroes
Download this eBook to learn about the individuals who dedicate their talents to give patients an opportunity for healthier and longer lives.
Getting “Engaged” in the Time of COVID
When using remote sites to perform clinical trial procedures, keep in mind things like whether remote sites are considered "engaged" in research. Read more:
What Do Auditors Look for When Performing SDV and SDR?
Understanding what auditors look for and why when conducting SDV and SDR will help ensure your next site audit goes well. Read more:
Community Consultation in the Time of COVID-19
COVID-19 complicates traditional models of community consultation. How should sites conducting planned emergency research approach community consultation?
How Oncology Research Is Advancing Better Research
Innovations in oncology have sparked advancements in the clinical trial industry and empowered COVID-19 research. Read more:
Developing a Clinical Trial Budget Following Medicare’s Clinical Trial Policy and Device Regulations
Learn tips for developing and negotiating a clinical trial budget according to Medicare’s rules and regulations for device and drug clinical trials.
Safety Precautions for Laboratory Research With COVID-19 Specimens
The pandemic has brought biosafety to the spotlight. This blog discusses guidelines and safety precautions for handling COVID-19 specimens.
Trial Design in the Time of COVID-19: Complex and Efficient
Complex trial designs can eliminate less-promising investigational treatments quickly to speed development, but they remain under-utilized. Read more:
Are “Virtual Trials” Mainstream Yet?
Advarra VP of Insitutional Services James Riddle discusses using virtual trial components in traditional study designs. Read more: