NewsObserver.com Article by: David Ranii firstname.lastname@example.org October 1, 2013
RALEIGH — With a network of lawyers around the globe, Clintrax Global boasts that it can help drug companies launch clinical trials faster by quickly negotiating critical contracts without sacrificing quality.
The Raleigh startup, co-founded and led by a former director of legal affairs at giant contract research organization PRA International, has a single-minded focus: negotiating contracts with doctors’ offices, hospitals and other healthcare providers that participate in clinical trials. A large clinical trial can involve hundreds of sites in many countries; the contracts can cover both payment for the clinical trial work and, in some cases, compensation for pertinent medical services rendered to the patients who participate in the trials.
Founded in January, Clintrax already has a dozen employees – 10 of whom are based at the company’s North Raleigh office – and a network of 53 lawyers around the globe, most of whom are independent contractors. Those lawyers can negotiate contracts in 62 countries in local languages.
CEO Brandon Evans is stingy with details but says the company has already attracted work from several large drug companies and several large CROs. CROs, which help drug companies manage clinical trials, often negotiate contracts on their clients’ behalf.
“I had a goal for us the first year to negotiate 1,000 contracts globally,” Evans said. “We have surpassed that in multiples.”
One customer retained Clintrax to negotiate with 450 sites in 15 countries.
Clintrax executives say the time involved in negotiating contracts with clinical trial sites, known as investigator sites in the industry, often can delay clinical trials. And time is definitely money for drug companies, which first have to complete clinical trials and then obtain regulatory approval before making a drug available to patients. That process takes years.
“Pharmaceutical research is all about timelines – getting things done as quickly as possible,” said Steven Jones, Clintrax’s general counsel.
Clintrax couldn’t have set up operations in a better location. The Triangle is the epicenter of the CRO industry, with more CRO employees here than anywhere else, and three of the world’s largest CROs – Quintiles, INC Research and PRA – based here. In addition, the Triangle is a hub for pharmaceutical and biotechnology companies.
In the spring, Infinity Pharmaceuticals, a publicly traded drug-development company based in Cambridge, Mass., hired Clintrax to negotiate contracts for a clinical trial utilizing more than 100 sites worldwide. Infinity, which in the past has both handled contracts internally and outsourced them to CROs, was so pleased that it has hired Clintrax for additional projects.
“Clintrax delivers the perfect combination of quality and speed,” Seth Tasker, associate general counsel and director of legal affairs, said in an e-mail. “They are flexible and knowledgeable, thoughtful and responsive, and they really understand the world of clinical contracting in a way that many CROs do not.”
Tasker described Clintrax’s pricing as “very competitive and often better than traditional full-service CROs.”
Evans, who started Clintrax with two partners whom he declined to identify, said that negotiating contracts with clinical trial sites is frequently treated by the industry as an afterthought. Moreover, the contracts often are handled by non-lawyers, a source of frustration for the in-house lawyers who review them.
“This is our sole focus,” Evans said.
Clintrax also has a cloud-based tracking system that enables it to keep clients up to date on contract negotiations. Clients can opt to receive regular reports – as frequently as daily – or they can log onto Clintrax’s system themselves at their convenience.
“We feel half our work is doing it,” Evans said. “The other half is being able to adequately report to our clients what’s going on. For instance, if a client has a study with 400 sites, they may want to know specifically, at any given time, where one of those contracts is” in terms of negotiating status.