Info & Opinion
June 1, 2016
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
It had been a while. Years, actually. But Bruce Schatzman, president and CEO of Advanced Clinical Software (ACS) seems to be doing even better than we expected. He started the firm back in 1993. In our last conversation, published here a long time ago, he wasn’t too worried about Oracle. That proved correct.
ACS never needed money from Wall Street or venture capitalists, and Schatzman says it’s profitable. Technologically, ACS is ahead of some peers in having a single database for several different modules of its technology, and in having seen the virtue of combining mission-critical applications that some firms struggle to unite. Integration is coming, as we wrote here, and here. Schatzman isn’t working with integrated voice response (IVR), but he gets the integration case.
The heritage of the firm is in developing tools to assist clinical sites. “We’ve been doing this for many, many years,” he says. “Study Manager is known worldwide. It is a very popular brand among research centers.” Some 1,800 organizations have used it. Given that the software is used in hospitals, it’s no surprise that it is both 21 CFR Part 11 compliant and adheres to HIPAA.
Competing With Excel
More recently, for the first time, the company has released a version of its software specifically for sponsors of clinical trials. Schatzman thinks it will be particularly interesting to biotechnology firms. “Ninety-nine percent of all software out there was designed and developed for big pharma,” he says. “The smaller biotechs are completely underserved from a technology perspective.”
His technology could also appeal to contract research organizations wanting to jump into technology. “The tightness and simplicity of this package is something CROs can use. We’re not going after Quintiles or Parexel,” he says. “We’re going after hundreds of small to medium contract research organizations which are using homegrown technology, like Microsoft Excel or a system that runs on soybeans.”
If you needed to label the ACS Study Manager tool, it’s probably mostly a clinical trial management system (CTMS), though it includes electronic data capture (EDC), clinical data management, and other features that help track documents for institutional review boards (IRB). And online training for administrators.
Based in Seattle, the company bases its software on the Microsoft .Net platform, not Oracle, with a Microsoft SQL Server database as well. “We think .Net has a bright future and offers a lot of power,” says Schatzman.
He adds that his firm deliberately elected not to design its products around the needs of large pharmaceutical companies. And in freshening up Study Manager, now in its 13th version, the company elected to make sure biotechs that didn’t want to buy umpteen different software packages would have most of their needs met by Study Manager.
Schatzman sees the biotechs as auspiciously expanding and growing just now, with chemistry-oriented companies looking for acquisitions or alliances with firms that are not yet vulnerable to generic competition. “Larger pharmaceutical companies are starting to partner with biotechs and putting their own money into that pot,” he says.
But biotechs are in a bind when it comes to acquiring technology to expedite their trials, he says. “They just don’t have the resources to lay out that kind of money, because they didn’t put it in the budget in the first place, but they also don’t have the staff on hand to deploy a team of people to implement a sophisticated, complicated package.”
Schatzman insists that rather than the 6-12 month time line needed to get a behemoth CTMS up and running properly, ACS can have customers off to the races in 30 days. He readily admits that Study Manager may not have every last bell and whistle. It can’t manage human resources. But it can provide reports on plenty of other variables, including patient recruitment. “It really does empower biotechs and give them a much better range of options to mange their research without all the hassle.”
Having said that, he can let users create case report forms (CRFs) in a drag and drop manner. “The process of creating the CRF automatically creates the underlying database,” he notes. “Some people refer to that as an adaptive database.”
Not Pursuing Top Pharmas
Reports from the system are online, allowing a nervous senior manager to log in and check patient accrual levels at 3:00 a.m. if necessary, Schatzman says.
The biotech firms, he says, recognize that their software for clinical development may not be what it should be. “The biotechs are faced with a much less efficient clinical development process because they don’t have the tools,” notes Schatzman. “We’re focused on the market that Oracle, Phase Forward and Medidata can’t touch.”
Mentioning another well-established name, Parexel’s Impact CTMS, Schatzman says that some systems are too complex to be actually embraced and used to the extent that the technology may allow. “We’re not trying to fool anyone that this is just as sophisticated as Impact. It’s not,” he says. “But this is what [clinical operations personnel] have time to track anyway.”
Lower, Predictable Cost
Technology, he says, will give a large company more confidence in the clinical data of a biotech company to be acquired. “[Technology] will quell concerns in the due diligence process about how accurate the data really is,” he says. “It will assist biotechs with that acquisition process because they have a professionally built and validated system.”
Pricing on the ACS platform is by usage. Getting started can cost a fraction of what some competitors charge. Customers can buy blocks of 1,000 patient visits, then recharge their account once those visits have been processed. “It’s a pay as you go model,” he says.
But it’s not just about the cost. The ACS value proposition is that some other clinical trial technology suites are too big, too complex, and too hard to set up for large numbers of small or mid-sized companies. Says Schatzman: “We’re lowering the bar in terms of what it takes to deploy this product and get immediate use out of it.”