What are the indispensable elements of an eclinical suite? What are the obligatory applications that any well-managed clinical trial will depend upon? Yes, electronic data capture (EDC). What about imaging? And ... drum roll, please ... drug supplies?
Such questions are a bit more urgent in the wake of BioClinica buying two companies this month.
One purchased firm, CardioNow, extends BioClinica's existing offerings as an imaging core lab, adding the ability to move large numbers of medical images. CardioNow specializes in transporting huge DICOM files.
BioClinica expects CardioNow to let it sell a more complete, end-to-end control of radiology studies for research, from the acquisition of the picture to its archiving. "We can start saving people money and giving them better response times in the next two months," BioClinica president and CEO Mark Weinstein says.
Indeed, when the imaging files are hundreds of megabytes in size, and it's necessary to move thousands of them a week, email attachments won't cut it. Serious systems and networking are needed, especially since CardioNow had 500 institutions using its technology for cardiovascular research.
The other acquired firm, Tourtellotte Consulting, randomizes patients over the phone and the internet. It can handle the tasks of any interactive voice response system (IVR). But the company can also simulate and manage drug supplies. That's more unusual. (ClinPage wrote about Tourtellotte in this story last year.)
While many vendors and contract research organizations offer randomization, it is rare to have deep expertise in automating mid-study supply changes. One needs biostatistical chops and logistical knowledge to ensure that trials don't run out of medicine or bankrupt their sponsors by manufacturing vastly more drug than is actually needed.
Advanced drug supply management, in short, could be a major differentiating factor—something that puts BioClinica in contention for eclinical projects of every level of scale and difficulty. Weinstein and his systems are ready for adaptive trial designs, but he believes most firms in the industry will first explore approaches with less regulatory risk.
Medical device trials, because of compressed time lines and large numbers of patients, may present a more immediate and significant opportunity for BioClinica, given its prowess in imaging and a more seamless eclinical suite than competitors. It sounds like a new device-oriented product could be in development at BioClinica.
One unknown complication, at this stage, is the speed and skill with which BioClinica will be able to combine its recent purchases (which include Phoenix Data Systems). The race to build bigger, more comprehensive systems is on, and it is no longer one in which small companies can prevail.
One of Weinstein's competitors (Phase Forward) recently bought not one but two IVR systems. Another rival (the IT unit of Parexel) has deep experience in imaging, IVR and data integration. The contract research organization inside United Health Group, finally, just built an eclinical system from scratch. When sauropods like these bump their chests together, smaller beings should simply take cover and wait for the ground to stop moving.
Weinstein is not cowed by his fellow mega-dinosaurs. After all, one of them lacks both an IVR and an imaging solution. "We can accelerate the growth of these various pieces," he says. "We are very, very interested in interesting technologies and even more interested in the people that come with them and the clients they serve."
Weinstein says that with almost 500 employees and $70 million in annual revenues, BioClinica is now large enough to shoulder the call desks, data centers and other infrastructure that is critical to support a demanding sponsor community. "As we add pieces, we can get more efficient," he says. "If I was a small player, I would be concerned about getting the critical mass to be competitive."
Some of BioClinica's resources may have been useful in this week's acquisition of Tourtellotte Consulting. Tourtellotte had several big pharma customers, but one goliath owned an IVR system that Tourtellottte built and serviced. That strategy, says founder Ed Tourtellotte, left him with fewer resources—especially to develop software—than he might have liked.
Even so, the company managed to support 150 trials a year and to develop unique technology to both simulate supply needs in virtual trials—and manage randomization and drug supplies in actual studies. As far as we know, no other firm offers a similar product suite that can be given to customers for both simulating and managing randomization and drug supplies. Similar services exist in an outsourcing mode, but are typically run by academics or biostatisticians outside the sponsor's environment.
BioClinica, in contrast, will continue to refine the Tourtellotte products. Then it will offer them to sponsor firms of all sizes and budgets. What seems to have caught Weinstein's eye about Tourtellotte is its potential to reach a much broader swath of the industry, which currently may not have affordable, easy-to-implement drug-supply management tools.
Such software, Weinstein says, can provide an excellent return on a sponsor's investment—one larger than just using systems for the mundane collection of clinical data.
The possible savings, Weinstein says, may be as high as 20-30 percent of the budget allotted for drug supplies. "It's hard to find another part of research where you can save that kind of money for your clients," he says of drug supply management. "That is worth an amazing amount of money to the sponsor."
Ed Tourtellotte agrees: "It's not so much saving the money, which you surely do, but saving the trial. Boy, is it worth it not to have the trial halt or an emergency mitigation in the middle of the trial."
Tourtellotte recalls that as recently as 2006, simulation was still novel, still unusual. "Now, people come up and say, 'We need that,' " he says. Asked to guess the extent of trial and drug supply simulation in 2016, Tourtellotte ventures that it may be ubiquitous by then.
For now, elsewhere in the landscape of technology and outsourcing suppliers, some telephone-based randomization systems are hard to connect to the systems that assign and track shipments of drugs to depots and sites. It will interesting to see if technology firms, service firms or both develop similar capabilities.
One of Tourtellotte's most prized systems—Trident—allows ordinary humans, not programmers, to set up randomization. Avoiding programmers, he says, saves money and adds speed and flexibility to the trial start-up process. Once a Trident simulation is complete, the randomization is ready in minutes, not the weeks or months that other IVR suppliers may need.
The new IVR technology from the Tourtellotte purchase, Weinstein says, will slowly supplant the company's existing technology in new projects. Ongoing trials, needless to say, will be fully supported on older systems.
But in general, BioClinica is hoping that its old and new bits of software will help it offer something rare under the clinical sun: agility. In theory, agility could be especially irresistible to cash-constrained small and mid-sized pharmas that, unlike the most mammoth firms in the industry, live within tight budgets.
Small- and mid-sized sponsors, Weinstein says, already grasp the value of integrated solutions like BioClinica's, especially when the package includes a few cutting-edge tools of the type that Tourtellotte and CardioNow have been offering. Says Weinstein: "More and more development will be done by the small and medium-sized guys. We have the advantage to be able to give the small to medium-size guy something he has not had access to. We think that will be well received."d9A2t49mkex