As far as we know, Michael Harte was at etrials since the beginning of time. Or maybe before the beginning of time. We’re not saying he’s old. We are accusing him of being the prototype for the anti-salesman—quiet, cautious, philosophical.

Year after year, he was a rainmaker, reeling in some of the clinical trial technology company’s larger deals. But management has been changing at etrials, and Harte left the firm late in 2008. He is taking a few months to figure out his options. He’s started his own consulting firm, The Harte Group.

In general, over the long run, Harte’s hoping to assist firms that are adapting to a new more compartmentalized, fragmented landscape of outsourcing. Some people term this “functional” outsourcing. Harte calls it “virtual” clinical development. He believes the new approach is still challenging and unfamiliar enough to require fresh ideas and energy.

New Puzzle

“Virtual drug development is putting together a core team of domain knowledge and expertise and then going out to find the pieces you need,” says Harte. “You see that with a lot of biotechs.” It’s not easy, especially as trials become big and global.

What biotechs want and get, he says, are not necessarily the same thing. It may be that individual initiative is not always a quality that is cultivated in the industry’s largest firms. Says Harte: “The [biotechs] want people to take more ownership. They want them to be more proactive. That today hasn’t happened.”

Watershed Era

Technology, he says, is facilitating virtual clinical development in ways that sponsors, vendors and contract research organizations (CROs) are still sorting out. Harte’s goal is to help facilitate some of the larger projects for firms that don’t like the traditional, full-service outsourcing model. Says Harte: “I can run a global program with three or four different monitoring groups all spearheaded through one point of command. The infrastructure is there to do it. The pieces are all there.”

Virtual development, he says, is being driven by sponsor demand. Supply is also a factor. Which is a nice way of saying that big companies like Lilly or Wyeth are lopping off entire departments, carving out areas of expertise that were formerly considered “core” skills. Says Harte: “I am seeing changes and trends that I have never seen in my 15 years in the business. You are seeing a wealth of experience hitting the marketplace.”

Bait and Switch?

But that expertise can be spread fairly thin at some CROs, causing biotechs that are not household names to feel they are getting the third-tier talent to work on their trials. If you never see key team members after the bid defense, Harte notes, or a senior manager is assigned to the project to keep it on track, those should be warning signs. You may have seen the supplier’s A team fleetingly, to attract your patronage, but have the C team actually working on your project. Says Harte: “Everything that gave you the confidence to make that decision is now gone.” Biotechs believe they’re helping to train staff for large pharma, but don’t necessarily receive much in return. There’s frustration.


Michael Harte

Harte was never inclined to mince words. He thinks that there are just too many slightly unique standard operating procedures (SOPs) that have multiplied like kudzu and greatly complicated the delivery of trials for hundreds of firms, especially in a new era in which so many organizations participate on the same project.

Lumbering Dinosaurs

The sponsor and CRO communities, he says, will be obliged to figure out ways to simplify their usage of overlapping SOPs, even if it is just to tell preferred suppliers: “You know, it is fine to use your own SOPs if that will make you more efficient on this trial.”

Harte thinks that larger CROs may not be nimble enough to prosper in the new environment. The industry “knows the internal processes are not working and the SOPs have created an issue. They are not able to produce timely drug development. Full service CRO companies were born off of that model,” says Harte.

He thinks it’s time to try something different. “The whole industry grew into these full service companies,” he says. “We all know the full service companies don’t do everything well. The industry needs a change, a shot in the arm and a different way to do business. Hopefully I can provide one of the vehicles.” As an example, he says, auditing a large number of smaller CROs will be one challenge in the new environment.

One of the providers he may point clients toward is his former employer, etrials. He knows etrials can support the efficiencies sought by industry. In some cases, Harte believes, a proliferation of databases creates reconciliation issues as sponsors sort out which database has the most current or correct information. That problem can be avoided by only using a single database from the outset, as etrials and a few other firms do.

Similarly, within contract research organizations, there can be conflicting agendas between, say, data managers or monitors. The fee for one might be kept artificially high not for economic reasons, but to protect all the revenue for the parent provider. Splitting up the work, Harte says, may reveal much larger cost savings in the 20-30 percent range.

A Smaller ACRO?

In his free time, Harte will be working to help small CROs and technology firms network. He has a vision of being a human pivot point for a number of the smaller companies supporting the virtual drug development model. He’s not ruling out big firms like Quintiles participating, but says the main appeal will be for smaller firms without the means to pay the six-figure membership fee of the Association of Clinical Research Organizations (ACRO), which we profiled in this article.

With perhaps a dozen blue-chip members, ACRO is not necessarily able or interested in assisting smaller, boutique firms that employ significant numbers of people. Observes Harte: “The smaller niche providers, the independent contractors, those groups are emerging and becoming even stronger. There needs to be a way to come together and have a stronger voice. There are different needs for these groups than you would find with the full service CRO companies.”

Harte will be using his own Rolodex to develop what potential member firms would need and how to deliver it. Says Harte: “A number of these folks would love to get involved and collaborate with other industry folks, not just about industry topics but about growing your business.” People who want to discuss that with Harte can send .(JavaScript must be enabled to view this email address) or give him a ring at 215.766.2397.