Beginner’s Guide to Investigator-Initiated Trials
While many clinical trials are initiated by industry sponsors, such as pharmaceutical companies or contract research organizations (CROs), other trials
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Is GDPR Coming to the US? CCPA and Its Impact on Research
Remember on the older The Price Is Right game shows with Bob Barker, when the announcer would describe to the contestant they could win “a brand-new car!” and then proceed to describe the car? Part of the description was always that the car had “and California emissions.” Why was that? What was so special about California? Turns out the state of California had different, more restrictive, pollution rules from the rest of the country; and if you wanted to sell cars in California you had to meet the California standards. It was difficult for car manufacturers to produce cars separate just for California, so eventually the country normalized on one standard, which looked a lot like the original California emissions standard.
Q&A – The New Urgency of Clinical Trials: How Oncology Leads the Evolution
In Advarra’s recent virtual symposium, experts from industry and academia met to discuss how oncology research has influenced agility in clinical trial design, particularly during the COVID-19 pandemic. Panelists talked about how the COVID-19 pandemic has impacted oncology research and propelled the field’s groundbreaking contributions to research. They also explored ways the pandemic response has shaped the future of oncology research—and research in general.
Improve Data Quality With 5 Fundamentals of Clinical Data Management
Gathering high-quality, reliable and statistically sound data is the goal for every clinical trial; and effective data management is essential to ensuring accurate data collection, entry, reports and validation. As a critical phase of the clinical research process, it’s important to establish and maintain organization-wide standards for data management to ensure consistency across all individuals and teams involved.
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.
Clinical Trial Budget Negotiations: A View From Each Side
Budget negotiation success hinges on clear communication and early resource sharing, helping sites and sponsors align expectations and avoid costly delays.
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.
IRB Review of Virtual Trial Technologies
Our webinar proved so popular, we thought a deeper dive would be appropriate. In this post we explore some key issues IRBs face when reviewing research involving virtual trial technology.
Q&A – Site and Patient Engagement
CEO Gadi Saarony and Deb Tatton, Parexel Senior Vice President of Global Clinical Operations, consider ways to improve site and patient engagement in this Fireside Chat Q&A blog part 2.