Earlier this month, we chatted with Jack Lawler of Cephalon about his experiences with the Impact clinical trial management system (CTMS) from Perceptive Informatics. Lawler believes that bolting a few reports on an electronic data capture system does not a CTMS make.

Perceptive, of course, is a division of Parexel International, out of the Boston suburb of Waltham. As many readers know, the company is a large CRO that currently adopting the Impact software to be able to manage its own customers' trials.

But in chatting with Kate Trainor, VP of the integration services group, we had new insight into what the company believes sets its product apart. Let's start with the basics. "CTMS is an enteprise application," says Trainor. "EDC is a project based one. A CTMS is more of a hub of your enterprise. EDC does not equal CTMS." As an example, she cites planning, cost estimation and drug supply management, which Impact and its rivals can handle.

Perceptive is about to debut a new Impact communications module that gives investigators more granular information about specific therapeutic areas and payments they are owed for services rendered. Trainor says that visibility across multiple trials is probably one of the most important features of a world-class CTMS. Users want the ability to see look across clinical investigators, in other words, and not just those associated with a single trial.

Once you have that, she points out, tracking and managing site performance across programs is possible. "Some of the generic things that are really important right now are site relationships and site satisfaction. You want to make sure you have an inventory of relationships that you can rely on. CTMS helps you manage that. You don't have that ability in EDC."

The company has rolled out a web-based version of its program, and that allows traveling site monitors and others to keep a local version of the data on a laptop. Perceptive is working with data, but understands that sometimes people just need to export data from the CTMS into Excel and other programs.

In an ideal world, she says, the CTMS should connect to a variety of systems that can be used on an project-by-project basis. In some cases, Trainor notes, the CTMS would be the unifying element that would connect a data management system, an interactive voice response system, an EDC system and a drug safety system.

For the company's Todd Joron, corporate VP and general manager, the industry's focus on EDC is a bit ... backward. "The CTMS is the backbone of the whole clinical enterprise," he says. "EDC hangs off of that."

Are the established clinical trial management system (CTMS) vendors impregnable? Invulnerable? Unassailable?

The people at DataLabs don't think so. The California electronic data capture (EDC) vendor took a bit of its DNA from the contract research industry. And DataLabs managers have heard from customers about the need for more service-oriented stuff in their product suite. Specifically, DataLabs says, people need more management-, collaboration- and communication-oriented functionality on top of or alongside EDC. Zik Syed, DataLabs' VP, product management and collaborative solutions, tried to explain what the company's CTMS product, Site Manager, can do.

It is fair to say that DataLabs thinks the CTMS niche could use some fresh air and new thinking. Syed notes that one major, well-regarded CTMS is based on Lotus Notes.

Lotus Notes, your correspondent can say from personal experience, is the only non-Microsoft application that has caused us to seriously consider sloughing off this mortal coil. Buying the farm. Crossing to the other side. It was that bad. That the visionary behind Lotus Notes now works at Microsoft is entirely appropriate. What other firm could make full use of his talents? In which decade of the coming century will secure, fast, searchable email for the enterprise liberate those chained to their cubicles?

Getting back to DataLabs, its Site Manager product does not have every last feature and function of  the CTMS giants. It does not appear to be able to look across trials-an omission the company hopes to rectify.

But the idea was to get started with something, Syed says. The key was that customers had unmet needs to connect clinical sites and manage the attendant paperwork. Market categories such as "electronic data capture" or "clinical trial management system" may not adequately embrace what the customer needs to do. "The communication challenge and the collaboration challenge that a company has is outside of that," Syed notes.

DataLabs's philosophy is that--never mind those big CTMS competitors--the clinical trial sites of the world are crying out for some streamlining. "When we look at it, it is pretty natural to turn it over to electronics," says Syed. "Our opportunity is to fundamentally change the way you interact with the sites from beginning to end. We are doing customer relations management (CRM) and treat sites as customers." It's an approach that Kendle International seems to like; that CRO is using the DataLabs CTMS software.

Specifically, Syed says, frequently-asked questions documents and a variety of other information that needs to be broadcast to a lot of people at the same time can be handled by DataLabs' Site Manager. Says Syed: "This is a communications portal. It allows you as a sponsor to publish information. It has hooks to tie it to the EDC system. You've extended the CTMS system out to the clinical trial sites in the same way EDC extended the data management out to the sites."

By definition, Syed says, DataLabs will have to connect to rival EDC systems. "Customers are asking us to connect with other EDC systems," he says. "We believe that is where the industry needs to go." 

DataLabs is also thinking about information external to any EDC system. The company is trying to address the problem of six different Excel spreadsheets all containing similar, but not identical information about specific investigators, timelines, deliverables, protocols or budgets.

The company also enable ways for information to flow back to the sponsor side of the equation: its system allows polls of sites and submission of electronically signed documents from the sites. Just not faxing all day long could be a boon to some sites and sponsors, we suspect. DataLabs is working on a separate software module specifically designed to collect and digitally sign regulatory documents such as 1572 forms from investigators.

Can the DataLabs system handle payments? That question typically causes some EDC vendors to curl into the fetal position and remain silent. Not DataLabs. Syed says the company has grown weary of traditional CTMS suppliers strutting too much on the can-you-handle-payments point. "Every vendor gets up and thumps their chest and says, 'I have the payment module.' Our thing is to provide the workflow and capability so that the system they have can continue the payment processing." That means DataLabs can trigger notifications or events surrounding payments to sites, enabling  requests to the accounts payable department or other financial fiefdoms.

Nick Richards, the chief operating officer of DataLabs, says that he and his colleagues hope that its CTMS solution will be as paradigm-shifting as EDC itself was when it first came along. Just as traditional contract research organizations were hesitant to admit somewhat mind-boggling inefficiencies in data management, he says, traditional CTMS suppliers may have not enabled online collaboration in a way that users of eBay would expect.

Proud as Richards is about what his company has already done, it doesn't sound like he thinks other EDC vendors will stay away from the clinical trial management space. "We're at the beginning of the process in the clinical trial management world," he says of the shift toward EDC systems that facilitate collaboration and communication.

"You're getting this new class of collaboration of extending out all the things besides data management," says Richards. "There is this whole collaboration space that CTMS has done nothing about."

What about the most critical tool in all of clinical research? What about the database? Is there an optimal design for all sponsors? How can the needs of operational speed, on the one hand, be balanced with the demands of analysis and reporting about the operational realm?

Is the proper model for the database one large, unified centralized database that contains everything the company needs to know? Or is a federated approach, with linked subsidiary data reservoirs, the preferred solution?

Folks, we need help on this. What follows is our brief understanding of an unfolding debate in the industry. This question may have ramifications for the user experiences at clinical sites, and therefore for the rate of adoption of technology generally.

Reconciling the needs of operational teams (people who gather and clean data) and the needs of managerial teams (which analyze and report on data) will not be easy. A pure focus exclusively on the operational needs may ensure faster system performance--but require middleware that may or may not work. The unified data warehouse, on the other hand, may facilitate better analysis across multiple trials but impose draconian, unthinkable compromises on stakeholders (perhaps Phase I study teams) who need more specialized, custom-tailored solutions to get their work done. Some data warehouses, we dimly recall, have had lofty ambitions that have never quite been realized.

Here's the bottom line.

Electronic data capture is here to stay. Data warehouses are here to stay. What should connect them? How big and massive should clinical trial databases be? Will a federated approach be easier--or only appropriate for smaller companies that have not made major investments in Oracle databases? Readers are invited to write the correspondent with opinions, facts and real-world experiences.