News

The Critical Issues Sites Need to Track During a Clinical Trial

Congratulations! You have gone through all the necessary steps to launch a clinical trial. Now it’s time to move on to the next one, right? Wrong! A successfully managed clinical trial requires ongoing tracking throughout its duration. Careful tracking ensures your research organization remains compliant and that your site is compensated properly for the study. […]

News Release – BRANY Names Michael Belotto as Chairperson for Social-Behavioral IRB

NEWS RELEASE BRANY (brany.com) has announced that Michael Belotto, PhD, MPH, CCRC, CCRA, will serve as chairperson for their social-behavioral IRB. The SBER IRB is comprised of a multidisciplinary group of experts in social and behavioral research, as well as human subject protection. “Dr. Belotto has been a great contributor to BRANY IRB’s success over the past […]

The Revised Common Rule and New “Concise Summary” Requirements

Our own Linda Reuter offers thoughts on how to meet new ‘concise summary’ requirements on informed consent for clinical trials. https://bit.ly/2JUQ8o3    

New CITI Program Courses and Webinar Help Researchers and Institutions Meet Regulatory Requirements

(Miami, FL) — The Collaborative Institutional Training Initiative (CITI Program), a division of BRANY, has announced new online courses and webinars designed to help research professionals understand and comply with regulatory requirements for clinical trials. The three courses and webinars address critical regulatory requirements: Transitioning research to the Revised Common Rule Protocol registration and disclosure […]

Is This the Right Study for Your Research Site? Five Questions You Should Ask Before Agreeing to be an Investigator

Clinical investigators often have multiple opportunities to participate in sponsored clinical trials. In addition to the professional satisfaction of being at the forefront of therapeutic development, clinical trials present an ability for physicians to offer patients alternatives to treatments they may otherwise be unable to access. While study sites may receive compensation for time and […]

Four Essentials for Clinical Trial Enrollment

Clinical trial enrollment continues to be one of the most vexing challenges for research institutions and sponsors. Despite one quarter of sponsors’ clinical trial budgets being allocated to enrolling participants, half of research sites enroll only one or no patients in studies. Recruiting a diverse patient population is an even bigger challenge, with ethnic minorities, […]

Reconciling Your Clinical Trial Protocol Start-Up Costs and Budget

As clinical trials protocols have grown more complex and more disparate teams are working on different elements of executing them, there is a potential for incongruency between the protocol requirements and the budget. It is critical to engage the stakeholders that will have a part in carrying out the research in the budgeting process. All […]

Burnout Among Research Coordinators — Warning Signs and How to Avoid Them

Let’s face it. Every job has its challenges. However, burnout seems to be at an all-time epidemic level. A recent report from Harvard University highlighted physician burnout as a public health crisis. A keyword search for “preventing burnout” yields 15 million results in Google. In the United States, problems associated with burnout are estimated to […]

Aligning Timelines for Better Coordination

Increased complexity of launching and running research protocols means different teams are contributing their expertise to ensure human subject protection, accurate budgets and successful patient recruitment. It also means that, with so many disparate groups involved, the risk of delays increases. One significant contributor to delays in study start-up is the lack of a common […]

Are Staffing Challenges Affecting Your Institution’s Research Profile?

Many institutions still struggle to recruit and retain the best talent for these challenging positions. A changing regulatory landscape, increasingly complex protocols and a litany of deadlines all contribute to a stressful environment for these employees. Additionally, salaries have remained largely stagnant, creating a general sense of disengagement. Staff turnover can lead to interruption in […]