Everything you ever wanted to know about choosing a contract research organization (CRO), but were afraid to ask—that’s basically what the folks at Sydney, Australia-based Novotech have created in their “Clinical Trials Checklist” for sponsors.

Novotech, the biggest of the four Australia-based CROs, recently began offering the handy list to potential clients. Really obvious marketing tool, or truly helpful instrument for newbie sponsors feeling lost?  Both, says Novotech founder and CEO Alek Safarian.

Benevolent CRO

“There are certain areas we have a particular strength in that we may have highlighted there,” he admits, then adds, “But mostly, the idea was developed from talking to clients who, over the years, all asked a series of common questions about choosing the right CRO. A sponsor might be expert at developing a drug, but may have never worked with a CRO before, and needs guidance.”

Safarian spent 10 years working for pharmaceutical companies before coming to Novotech. He says the checklist was put together for sponsors looking into coming to Australia for the first time, but its suggestions aren’t particularly Australia-specific. image

Novotech agreed to let ClinPage publish the complete list, below. And Safarian took time to discuss a few key themes with us.

Site Audit. Novotech’s list says making such a visit is key.

What can really be gleaned from a site audit? “Quite a lot,” Safarian said. “Seeing the offices of the company you’re working with, sitting down with functional heads of various departments, checking out the IT infrastructure—it’s all very important. Some of those things you can get a much better idea of from a visit. Many sponsors, when they come, will grill the IT department, will look closely at the connectivity [we can provide] when people are on the road, will scrutinize project flow. They can really only get that feel for things when they come here. The idea is to make sure the place fits them.”

He notes that only about half of new-client sponsors from the U.S. actually come for a site visit before signing on the dotted line with Novotech.

International trials experience. Novotech suggests sponsors make sure CROs they’re scrutinizing have a track record with regulatory agencies in various countries as well as mastery of the language(s) there.

Said Safarian: “Markets such as Australia, Latin America, Israel, Eastern Europe, India and China all offer new possibilities to the drug development industry. A few years ago, smaller biotechs and midsize pharmas were only conducting trials in their own domestic markets. Nowadays, increasingly, they are looking globally. Therefore, it’s important that the smaller CROs that they work with be equally well versed in managing studies not only in their own domestic market, but also in major world markets.”

Cost savings. Think small, save big, suggests Novotech.

“Global CROs, by nature of their business scale and overheads, come at a higher cost, and traditionally used to be the only outlet for executing a global development program,” said Safarian. “It is now increasingly more common for smaller biotechs and midsize pharmas to plan and conduct global studies by using a network of smaller CROs in different regions. However, this does require selecting CROs on the basis of their flexibility and ability to work as part of a larger network of vendors in concert with one another.”

Size match. Size matters, according to Novotech.

“When Pfizer outsources a large Phase III program, it looks to one of the three to four global providers it works with to execute on a $25 million program,” Safarian offered. “The quality of service, priority and responsiveness given by the global CRO are at its highest when working with its most important clients.  For smaller clients, that equivalent level of priority is provided by smaller CROs.  When there’s a size mismatch, there are greater possibilities for service delivery to be suboptimal.”

About Novotech

Novotech, founded 11 years ago, has worked with about 50 U.S.-based and European pharmaceutical and biotech companies on about 500 trials. It was named Australian CRO of the Year for 2006 by Frost & Sullivan, and a winner of the Deloitte Fast 500 Asia Pacific 2006 program.

Safarian says the company is full-service, offering everything except preclinical, and is currently managing about 55 trials. Growth has been robust. Five years ago, the company had 14 employees. Now it has 80. Safarian says that’s due to the semi-recent explosion in interest in conducting trials in his country.

U.S. Appendage

Safarian describes Australia as “an appendage of the U.S.” when it comes to clinical trials. The culture is similar, as are the demographics, he says. And more and more of the investigators in his country have been trained in the U.S.

The differences? The cost of running a trial is about 30 percent less than in the U.S., and the regulatory processes are faster. Says Safarian, it takes only two to three months to get a trial off the ground in Australia. “[Australia] makes a compelling case,” says Safarian. “More and more companies are discovering that. And those that have, keep coming back.” More than 80 percent of Novotech’s revenues come from outside Australia, said Safarian. Most clients are biotechs located on the west coast of the U.S. Others are European firms. A small percentage are Australian.

Small Company, Big Growth

Novotech’s revenues aren’t public, but Safarian says revenues have been growing 40 percent over the year before last for the last three years.

Though Safarian describes his company as a “generalist CRO” in terms of therapeutic areas, he says oncology is big for Novotech, accounting for a third of revenues. Other strong areas are cardiovascular, personalized medicine and genetically based studies.

In addition to its Sydney headquarters, Novotech has offices in Melbourne, Brisbane and New Zealand, as well as three in the U.S. (two in California and one in New Jersey).

New Frontiers

Next up? The Far East, says Safarian. “We are looking earnestly into the big markets there, patient-population-wise—those that are expanding rapidly. Being in the same region and the same time zone, we are increasingly asked about that.”

Safarian says he expects to have a new office open in that region within a year.

The three other major Australia-based CROs are Trident Clinical Research, DataPharm Australia and Clinical Network Services.

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Here’s the firm’s checklist:

Novotech’s Clinical Trials Checklist

• Size match—is the CRO a good match in organizational size, reach and experience working with companies at a similar stage and growth phase?  Common frustrations expressed by small to medium sized biotech companies working with the large global CROs, borne out of a size mismatch, revolve around response times and “client value/priority” issues and relative importance of their project in monetary and manpower commitment terms

• Site audit—be prepared to physically view the corporate headquarters and associated facilities/sites to ensure they are at the standards required and offer the features promised by the CRO.  This will ensure that the information matches the promised and required capabilities.

• Technology—ensure the CRO offers data collection and reporting compatibility with both the FDA requirements and your sponsor firm, including electronic filing of data with the FDA, etc.

• Patient recruitment record—CRO offers the speed, quality, constitution of patient recruitment together with ability to handle multi-center trials, rare disease recruitment, access to a variety of patient populations, e.g. India, China, Asia, etc.

• Demonstrated experience in the disease/condition/therapeutic class—experience in biotherapeutics, vaccines, protein therapeutics, small molecules, nucleotides, etc., delivery mechanism, complex formulation, etc., rare diseases, orphan drug indications, oncology, infectious diseases, etc.

• Demonstrated experience in the trial phase required by the sponsor—including the recent development with Phase 0 trials—and proof of concept (POC) studies, microdosing trials, first in human studies, etc.

• International trials experience—track record with FDA, EMEA, languages, time zones and culture differences and recruitment of patient populations from several national and international centers.

• Trial Development Assistance—CRO offers experience developing innovative trials for esoteric therapeutic approaches, ability to become a true partner through trial design and development.

• Local and World knowledge—expert knowledge of local regulatory procedures and international filing requirements is only part of the small portion of the capabilities that the CRO offers the sponsor.

• Cost savings—ability to work on tight cost structures and to scale development work to suit sponsor budget and cash flow.  Also by careful outsourcing and strategic relationships, a CRO can offer significant cost savings on any trial.

• Referrals—CRO should be a trusted source in the industry with a track record and be willing to provide a reference list of satisfied clients and completed projects. 

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