Public Perceptions of Clinical Trials: A Comprehensive Survey
The clinical research industry is only becoming more complex and competitive as organizations are inundated with multiple trials and tight
clinical trials
Top 3 Reasons Why Your Medical Device Needs a Clinical Trial
Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. While drugs
FDA Guidance Offers New Flexibility to Biotechs in Cell and Gene Therapy
The Food and Drug Administration (FDA) recently released new guidance regarding cellular and gene therapy products, one of which may
Getting “Engaged” in the Time of COVID
When using remote sites to perform clinical trial procedures, there are certain issues researchers must keep in mind, including whether those remote sites are considered to be engaged in research.
What Do Auditors Look for When Performing SDV and SDR?
Subject safety and reliability of data are paramount in clinical research. This blog outlines what auditors look for when performing source data verification (SDV) and source data review (SDR) during routine investigator site audits.
Community Consultation in the Time of COVID-19
How should sites conducting planned emergency research approach community consultation in the time of COVID-19?
How Oncology Research Is Advancing Better Research
The COVID-19 pandemic has challenged every aspect of the clinical research industry. This new urgency has affirmed certain clinical trial innovations originally pioneered in the oncology space.
Developing a Clinical Trial Budget Following Medicare’s Clinical Trial Policy and Device Regulations
Developing and negotiating a clinical trial budget that applies Medicare’s rules and regulations involves many challenges. Find out strategies to assist with the process.
Safety Precautions for Laboratory Research With COVID-19 Specimens
The current global pandemic has brought biosafety to the spotlight. Biosafety practices must be customized to the proposed research as well as the existing facility and local regulatory requirements.
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. The current pandemic offers a chance to consider strategies for facilitating adoption of such innovative designs.
Are “Virtual Trials” Mainstream Yet?
While some completely virtual trials are taking place, the real trend involves bringing virtual trial components to traditional study designs to improve study efficiency and reduce participant burden.