On Sept. 30, 2004, the day Merck withdrew Vioxx from the market, Lancashire, England’s Synexus Clinical Research was working on the biggest Vioxx trial ever.  “I nearly jumped out my office window,” jokes CEO Michael Fort.

The Vioxx saga turned out to be a blessing for the company, however. The FDA has quietly increased the number of patients it likes to see in post-approval trials. “Five to ten thousand used to be big,” says Fort. “Now fifteen to thirty thousand is standard.” Late-phase and post-approval recruiting and trial management just happens to be right where Synexus sits in the market.

Surging Orders

The company is extremely busy. “Our order book is on fire at the moment,” says Fort, adding that the company’s backlog is just shy of $60 million and it has bids out for $70 million in contracts.

“One of my biggest challenges right now is to make sure I can deliver on the order book. We have some hiring to do,” laughs Fort.

Multi-Pronged Approach

Ten-year-old Synexus is not your typical recruitment company, Fort likes to point out. It doesn’t scare up patients through putting out fliers, or asking time-stressed doctors to talk to patients on the company’s behalf. Instead, Synexus has a multi-pronged approach that starts with a large database.

“Because we’ve been doing this for a long time now, we’ve built up a huge database of people,” says Fort. The company’s database has about 250,000 people in it. “Either they’ve already been through a trial, or they applied to be in a trial and didn’t get in. They’ve expressed an interest to take part and are already over the threshold of needing to know what a clinical trial is.”

Scratching Backs

Next tact? Going through doctors. But not in the typical way, simply asking doctors to talk to patients. Instead, Synexus employs the judicious use of reciprocity in its physician relationships.

Knowing that doctors in the UK, under the National Health Service, are stretched to the max, Synexus will offer to help them. This may be by providing services for patients that the doctors lack the time or money for. The company can offer screening for bone density or diabetes, for example. “And all we ask in exchange is that we can talk to the patients about clinical trials,” says Fort.

Antibiotics in India

In other countries, Synexus takes this a bit farther, showing up in rural India with antibiotics and medical supplies that are badly needed. Or arriving in Bulgaria with boxes and boxes of insulin, as its government doesn’t subsidize full dosages for diabetics. In exchange, Synexus personnel get access to patients with a doctor or nurse present.

“That’s the key: if you can get a doctor or nurse in front of the person to talk to them,” says Fort.

TV Appeals

Approach #3? Television ads. Synexus was the first to get an ad on the telly in the UK recruiting patients. It was for a preventive prostate cancer drug, and the response was huge. “My God, we were beating them off with sticks,” remembers Fort. (Direct-to-consumer drug ads are still illegal in the UK.)

The company has done six or seven more such TV campaigns, all seeking patients for drugs that are preventive in nature.

Hub Sites

Once Synexus has rustled up the patients, it can run trials through thirteen “hub” sites in six countries. These are dedicated, clinic-like environments run by medical personnel who administer drugs and monitor patients. Not, in other words, the traditional general practitioner/principal investigator model in which a doctor is also seeing patients in his practice. That is the key to success, says Fort.

“This is not: ‘I just finished my morning surgery, so let’s have a look at this clinical trial now,’” says Fort, illustrating how research can often take a back seat in a busy doctor’s schedule. He feels that can doom a trial.

Fewer Sites

In contrast, Fort points to a four-year outcomes-data hyperlipidemia study that his company assisted with. The sponsor wanted 12,000 patients from 1,500 sites. Synexus, by managing, through just 10 of its hub sites, recruited and managed 21 percent of the trial’s patients, or 2,500 people. Which saved the sponsor $1.5 million in recruiting and monitoring. (That assumes an average cost of opening a site in the $30,000-$40,000 range for ethics board approval, site inspection, training, study materials and other items.)

“We can get much bigger numbers with fewer sites,” asserts Fort, adding that in one of Synexus’s hubs, one person can monitor the equivalent of 20 far-flung sites.

Global Growth

Currently, Synexus has 194 employees, 134 of them in the UK. The rest are in India, South Africa, Poland, Hungary and Bulgaria. Synexus is looking to expand. Fort was recently in Florida scoping out locations. Meantime, he’s looking for locations in Eastern Europe and South America.

The company, which had been public, went private again late last year after a dip in the pharmaceutical-outsourcing sector scared off investors, making it hard to raise capital for acquisitions, says Fort.

Synexus’s revenues last year were $30 million. Fort expects them to reach $100 million in two years.

—by

d9A2t49mkex