Info & Opinion
May 23, 2019
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
As far back as the late 1800s, when the eclinical landscape was an infant, all of the savvy companies paying for clinical trials agreed on one thing. Every research system for every trial must have its own database. This seemed smart at the time.
Randomization data? Its own database. Case report form (CRF) data? Separate database. Monitoring reports? Separate database. Drug safety information? Separate database.
The multiple-database approach gave birth to a problem. Suppose a clinical trial manager asked, Is there something that our clinical sites don’t understand about our adverse events?
Such an ostensibly simple question might require heretofore isolated systems to communicate. Which is easier said than done. That apparently simple question could flummox the IT department of a clinical development organization with more revenue than a moderately large Latin American country.
Indeed, when the companies paying for clinical trials asked for small databases to communicate, formerly macho IT quarterbacks would hunch their shoulders and stare nervously into the distance.
As a result, clinical trial managers learned not to ask two-database questions. Everyone knew the industry’s Balkanized, disjointed, silo-based technology landscape could not answer two-database questions unless great battalions of consultants and programmers were hired. There was a time when the industry had the money and time for such projects, but those days are behind us.
Enter Zaher El-Assi, general manager of the clinical trial division at Merge Healthcare. The Chicago company is pursuing a more unified approach, one also tested by a few firms such as Nextrials, DataTrak and Quintiles. Like them, Merge is now offering one database, one system. It has everything under the clinical trial sun.
El-Assi has the elegant, crisp demeanor of a CEO—as polished as you would expect of someone who came out of the Harvard-Partners organization and Millennium Pharmaceuticals prior to its acquisition by Takeda.
“What we are doing here is bringing it all under one umbrella,” El-Assi told ClinPage at the 2012 Drug Information Association meeting in Philadelphia. He was referring to the 14 different clinical systems Merge had built or acquired, many from the eclinical firm etrials. All those tools are now rolled into a single offering. “We finally have a tool that is truly end to end,” he says.
A La Carte Pricing
El-Assi believes the drug industry is ready to stop pretending that the ungainly and unnatural activity called “data integration” is working. The sponsor community, he reports, is ready for a cleaner way to access all clinical research data. Says El-Assi: “This is not a long term evolution. It is already happening.”
A single database makes it almost childishly simple to ask complex questions of more than one clinical trial data domain. Reports that used to be impossible are now easy. Questions that were never asked can be answered by anyone with the right system privileges.
Merge is calling its new offering an “operating system.” It’s not like the Windows or Unix platforms, But it can offer all the core, hyperspecialized features and functions essential for any modern clinical trial. There is a full list of capabilities here. They include electronic data capture, drug supply management, patient-reported outcomes, endpoint adjudication, site administration and payment management. Merge has deeper expertise in medical imaging than many industry suppliers, and clinical-trial-related imaging functions are in its system as well.
El-Assi says that many companies in the industry are eager for a simpler pricing model. Data that are online in the so-called cloud allow a la carte pricing. Customers who just need three clinical trial services, not 14, can buy just three. “We're charging for clinical events,” El-Assi says, referring to such things as a patient milestone, a data point logged, an image captured. “People don't want to pay large amounts up front.”
El-Assi says that his system can and does handle preclinical projects. Phase I and II trials that would previously have been run on paper are economic on his system. Customers testing the system are also coming back and booking larger numbers of projects. “We are getting significantly larger volume from customers,” he says. “What is going to change is our volume.”
The company says this approach is cost-effective. Noting that clinical trial-related revenue at Merge appears to be on a rate to double during 2012, El-Assi continues: “Today we are looking at 30-, 70- and 120-study deals. That is a very different business model. We are not concerned about revenue at all.”
El-Assi notes that his firm recently acquired a clinical trial management system company, ACS. That Seattle-area company had strong relationships with clinical sites; its software was tailored to their needs to a degree not found elsewhere in the landscape of sponsor-oriented clinical trial technology solutions. “We see the site piece as a great way to integrate electronic medical records with electronic data capture,” says El-Assi.
Like most of its competitors, Merge is dedicating resources to help the contract research organizations. Says El-Assi: “We help them sell. We support their sales process. We have a special contracts person assigned to them.” Medpace and Novella Clinical are using the Merge system.
Given that El-Assi faces tenacious and well-financed rivals such as the top global database company, we asked him how he is sleeping at night. Quite soundly, he replied: “People are fearful of what Oracle will do to the Phase Forward product. Oracle has been slow to release their strategy for that product line. A lot of their clients are looking for alternatives. Every one of my clients has my cell number. I am sure Oracle cannot offer that.”