As the research coordinator for a large cardiology practice, Sandy Maddock saw the good and the bad ways to conduct clinical trials for medical devices and drugs being developed to help patients.
Maddock, who also is a registered nurse, left the practice in 1999 to start her own clinical trials monitoring, auditing and consulting firm, IMARC Research Inc. in Fairview Park, Ohio, to help clients use the good ways.
As U.S. health care reform promises to cut revenue and squeeze profits of medical device and drug makers, services that reduce development costs by speeding trials and smoothing regulatory approvals are bound to become more important.
IMARC does that and more. “We act in some ways like a police officer,” said Maddock, IMARC’s president and chief executive. “We make sure that the laws are followed and we call people out when they’re not.”
Medical device or pharmaceutical companies use the services of IMARC and other contract research organizations (CROs) to research, develop and test their products before they can be approved for market by the Food and Drug Administration.
This research and development work has been increasingly outsourced to companies that specialize in the process. While some CROs provide end-to-end service, IMARC focuses on a small part of the process–monitoring and auditing clinical trials.
“We’re hired by companies wanting to get a new device or drug approved,” Maddock said. “And we provide a layer of oversight to make sure that what that company tells the FDA is true.”
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Maddock employs scientists and medical professionals who monitor or audit clients’ clinical trials for research process and data integrity, as well as for compliance with regulations. She considers her company an “independent judge” that gets paid whether its client reports are negative or positive.
“We have to communicate what it is we’re seeing at the site so they can either make it better, fix it or come up with an action plan to make sure it doesn’t happen again,” she said.
And it’s better to get bad news from IMARC than from the FDA. The federal regulator is increasingly keeping medical devices or drugs off the market after uncovering flaws in clinical trials. “None of the sites that we’ve monitored have ever received an FDA warning letter,” Maddock said.
Ideally, Maddock and her 14 employees get involved in a client’s trial soon after it is designed, educating physicians and other researchers what to do–and what not to do–to keep to clinical protocols and comply with FDA requirements.
“Sandy’s team brings up the [trial] site with us,” said Neal Fearnot, chairman of MED Institute Inc. in West Lafayette, Ind. “That means significant education for the staff, physicians, hospital administrators–anybody who’s on site and involved with running the clinical trial.”
Education helps keep researchers from making mistakes, so it often speeds trials. “She is an excellent educator,” Fearnot said about Maddock, who is considering making education a business line at IMARC.
MED Institute is the Cook Group Inc. unit that runs clinical trials for the group’s medical companies. With its 15,000 products, Cook is “probably the world’s largest private medical device company,” Fearnot said. “One component we almost completely outsource to [Maddock] is the monitoring activity.”
IMARC monitors test clinical trial data, read medical records and talk to staff, among other activities, to make sure MED Institute’s trial data is complete and accurate, said Fearnot, who has been working with the company since its inception.
Maddock said she is creating an audit division to provide more process-level scrutiny and feedback to research sponsors. The division eventually could offer good clinical (GCP), laboratory (GLP) and manufacturing (GMP) practice audits.
“In the end, our studies are so important, the FDA inspects the sites,” Fearnot said. “With Sandy’s help, we have no Form 483s.” The regulator issues these forms after finding something that’s not right during an inspection.
That’s “shockingly different from the experience of other companies of our size that have not only those 483s but the subsequent paperwork from FDA after having a violation, which would include a warning letter and legal action from Department of Justice,” Fearnot said.
In addition, Cook, MED Institute–and IMARC–have been praised for their trial work in the FDA’s establishment inspection reports, he said. “That’s almost unheard of in an FDA inspector’s report.”
A full-service CRO in Minneapolis uses IMARC for its overflow monitoring work. “They are a monitoring organization that provides high quality monitoring for
medical device companies, said Suzanne Sullivan, manager of the CRO’s clinical research services.
Some CROs have seen business drop off because of uncertainties posed to medical device or drug makers by health care reform efforts in the United States. IMARC has experienced no business slowdown, partly because most trial monitoring is outsourced, Maddock said. Rather, her company is growing. She expects to hire her 15th employee–to head the new auditing division–in early April.
IMARC also is doing more trial consulting work in Europe, Japan and Australia. And Maddock is taking her passion for training researchers on the road. She will speak at the Association of Clinical Research Professionals’ national convention in Tampa, Fla., in April about understanding and raising the bar for trial regulation.
“I want to inspire them to question,” Maddock said of conference attendees. Why? “On the other side of that negative trial data is a patient,” she said. “Because somebody didn’t take that data seriously, somebody got hurt.”
