clinical research organization

Running a Site September 9, 2020 5 Minute Read

Chief Operating Officer of MACRO Trials Talks About How Sponsors and Sites Can Increase Inclusivity and Diversity

Achieving representative enrollment – meaning diversity in race, age, gender and socioeconomic status – in clinical trials is essential to the development of cutting-edge therapies for the general population. Despite being recognized as a need within the industry, it has proven to be a longstanding challenge. According to the 2019 ‘Drugs Trials Snapshots’ report released...

Running a Site

6 Minute Read - August 9, 2020

Our Clinical Research Site Went Through an FDA Audit

Dr. James Clark of Charlottesville Medical Research recently had an FDA inspection of his site as it is a high enroller. He did not receive a FDA Form 483, and he was using the CRIO electronic source system on the study. Learn about his experience in this Q&A session. CRIO: What’s your background? Dr. Clark:...

Running a Study

20 Minute Read - July 8, 2020

What’s it like to be a Clinical Research Monitor? A Day-in-the-Life With a Top CRA

Disclaimer: The examples noted in the following article are all firsthand accounts of the author, but for the purpose of this article have been combined into a single site visit. The visit depicted below is an aggregate of many sites and studies and is not necessarily an exact representation. The original version was written entirely...

Running a Study

5 Minute Read - July 8, 2019

How to Manage Clinical Research Associate Burnout, From a Top Senior CRA

It is no secret that CRA turnover is a huge issue in the clinical research industry. It is not uncommon for sponsors or CROs to spend thousands of dollars onboarding a CRA, only to have them leave within one to two years after starting. Recent reports from the ACRP1 show that CRA turnover rates were as...