Colleen M. Sproul, JD President, and CEO

What inspired you to found Contracts Associates?

“I founded Contracts Associates in 2006, because I wanted to give pharmaceutical sponsors a way to ease the burden on in-house legal, and accelerate the clinical trial agreement process. At the time, the industry outsourcing model for accelerating the study start-up process was to bring in inexperienced recent law school grads or law firm attorneys with no in-house experience. I set out to change that.

Our team of attorneys is made up of thought leaders that steer our clients’ programs toward success and move the science forward. Our aim is to use our extensive in-house experience to empower our clients, helping them secure equitable contract terms and develop strategic contract review workflows.”

What motivates you in your work?

“The rich variety of our work means that I’m not confined to just one therapeutic area or drug product. Consulting for our clients allows me to work across the life sciences spectrum for clients all over the United States, and that’s very exciting. Each of us chose consulting as a career path because it gives us the opportunity to work hard and grow professionally without constraints.”

What are you excited about in 2022?

“The pandemic has caused seismic changes to the FDA approval process, the supply chain and manufacturer and sponsor oversight duties and obligations. Keeping up with the new guidance for the life sciences industry has been interesting and exciting. I am looking forward to seeing some of the more innovative approaches become “best practice” either via FDA guidance or updates to the ICH GCPs and cGMPs. The industry needed ways to move faster and while the cause for rapid innovation is a sad one, I am looking forward to adopting new ways to get drugs to market more quickly.”

Colleen M. Sproul is the President and CEO of Contracts Associates. Earning her J.D. at New England Law Boston, she began her legal career at Genetics Institute, which sparked her passion for supporting clinical research. She went on to gain in-house experience at Boston Scientific, Wyeth, and Cardiovascular Clinical Studies, and today is a frequent speaker and commentator on informed consent issues and FDA regulatory developments in clinical contracting.

Colleen has presented at Association of Clinical Research Professionals symposiums, the Massachusetts Biotechnology Council Law and Policy forums and has been interviewed for national news articles. She is a mentor in the New England Law Boston’s Bridge to Success program and is responsible for Contracts Associates’ corporate sponsorship of Girl’s Inc. of Lynn. She is a member of the Massachusetts Bar Association, the North Shore Technology Council, and the New England Women in Science Executives Club.