Ever take an antibiotic to clear up an infection? Get your annual flu shot? Take your child to the pediatrician to get immunized? Thank clinical trials for making it possible. It is only through clinical research that we are able to discover the safety and effectiveness of drugs.
Advances in medicine are due in large part to the people who volunteer for clinical studies. Each year more than 2.3 million people participate in approximately 80,000 clinical trials in the US alone. These trials would not be possible without the clinical research professionals who run them. May 19 is Clinical Trials Day—a day set aside by the Association of Clinical Research Professionals (ACRP) to help raise awareness about clinical trials and to recognize the contributions of those who help advance public health. Meet two professionals from PRA Health Sciences and see why they are committed to clinical development.
Senior Clinical Research Associate
Glen Brown, Senior Clinical Research Associate
What initially interested you in clinical development and to become a CRA?
I liked the idea of doing clinical research on new drugs from start to finish. I also enjoy learning what goes into a study and the history of the disease that I’m working on.
What inspires you to do the work that you do?
Helping bring drugs to market that can change a person’s life and knowing I was part of that study is very rewarding.
What challenges you in your work?
Working on new drugs, working with clinical sites, investigators and the many vendors associated with a well-oiled protocol. I feel challenged knowing that I am part of the team to test new drugs, reviewing and approving data before it is sent to the FDA, sufficient for FDA approval for marketing the drug for human use. Nothing is more satisfying than to see that first commercial on TV for a drug you helped with clinical review.
What accomplishments are you most proud of in your work?
Working as a specialized team to assure subject safety and efficacy of the new drug being tested, and working with people all over the globe. For me, I started in Quality Assurance in 1989 under the preclinical guidelines (GLP) doing PK, Drug Metabolism, etc. testing the safety before having it used in humans. I progressed into Clinical Trials in 1993 and I’ve been in this area since then.
What is a typical day like for you as a CRA?
Constant monitoring of assigned protocols, management plans, and procedures to assure the site is performing their duties to support patient safety, data, and efficacy. I also assist at the site when needed. Sometimes that involves training, making sure study recruitment is maintained, and resolving issues or queries that might come up. An important part of my job is assuring that sites avoid any deviations from the study protocol. I also verify all site records with the data entered into the electronic data capture system, monitor drug accountability and supplies, and assure regulatory submissions are maintained.
Any message you want to share about Clinical Trials Awareness Day? I have worked in the health, medical, and research fields all my life. I am fortunate since I have loved every day doing this. My advice is if you like being part of this field or similar, do it. You will not be disappointed knowing that you help a lot of people by working in clinical research. It’s a great feeling.
Senior Vice President,
Global Business Development
Doug Fulling, Senior Vice President, Global Business Development
What initially interested you in clinical development?
I was originally pre-medicine when I went to college and was planning to be a pediatrician. My sophomore year reality set in, as I was overwhelmed with the academic workload combined with being a student athlete. I decided to change my major and pursue healthcare management. This degree enabled me to still work in a field of medicine, but from a business perspective. As my career evolved I took an interest in the pharmaceutical industry, as I realized the impact it has on saving and improving lives, which is initially why I wanted to be a physician. I have been in the CRO industry for over 15 years now and enjoy working side by side with drug companies to bring new medicines to patients.
What inspires you to do the work that you do?
It is rewarding to see patients benefit from the clinical trials we have run for our clients. Nothing is more rewarding than to know somebody that is benefitting from a drug that PRA helped develop. I am inspired by being surrounded by smart, passionate researchers who are committed to helping patients who are in need. Finally, I LOVE my team and their dedication to providing excellent customer service to our clients – you won’t find a better or more fun team in the industry.
What challenges you?
Sudoku! I don’t get it and find it boring! In all seriousness, I am challenged with making sure I remember that an actual human being is at the end of all that we do. It is easy to forget when you are selling business or dealing with a challenging client, but these people could be our parents, friends, siblings or children and we should never lose sight of that.
Is there anything you would say to someone considering being part of a clinical trial?
Not only are you contributing to society in a big way, it could also save your life, or the life of somebody you know.