We always look forward to the publication of a new TouchBriefings. The British firm's projects delve a bit deeper. TouchBriefings addresses the knottier questions facing the industry. Visually, its articles resemble those in a peer-reviewed journal.

Late in 2011, a publication from the TouchBriefings team was dedicated to one topic, the increasingly pivotal clinical trial management system (CTMS). The TouchBriefing editorial package includes an interview with Christopher Heider, who is a director of IT for Merck's research effort.

Don't hold us to this. The details are few. But it sounds as if the new team at Merck pulled together its own people and folks from Schering and Organon, which Schering had acquired. They decided to make a gradual transition away from Parexel's Impact CTMS and toward Oracle's Siebel CTMS.

Having said that, there are no additional details on exactly how trials are migrated from two huge, customized CTMS to a third. Could Merck projects continue to use Parexel's system? When Parexel is helping on a Merck trial as a contract research organization (CRO), will its employees be obliged to use a competitor's CTMS? Did Merck consider any alternatives to Oracle and Parexel, or is it game over for small CTMS suppliers?

The article skirts the most daunting question facing big pharma's IT strategists. Are some large drug, device and biotech companies so large that it is no longer possible to merge their clinical trial systems? Combining financial and manufacturing systems is easy. Is clinical research the same? Just as some global banks are too big too fail (TBTF), are some firms running modern clinical trials simply too big to integrate (TBTI)? Who can say?

Matters Unspoken

As best we can discern from the article, the merging firms (Organon, Schering, Merck) had customized their CTMS to a significant degree. Those customizations brought new features. New strength. And that sowed big challenges for the integration and migration process after the companies combined.

Does the new system manage investigator payments manually or automatically? Not at all? Does the CTMS permit mid-study changes to randomization schemes, as would be needed in an adaptive trial design? How does the CTMS handle shipments of ancillary trial materials and drugs? The article doesn't say. It just notes how thorny the whole process has been.

To be fair, Heider is only quoted a few times. Since no author's byline is on the interview, it's tricky to sort out the various contributions of Heider and whoever interviewed him. For Heider, needless to say, getting his new colleagues to approve his published comments may have been as easy as a chubby American teenager gaining a spot on Kenya's Olympic team. Heider was no doubt constrained in what the company felt was appropriate to say.

Merger Aftermath

The article states: "Currently a stable of 40 or 50 systems are working in tandem, with the prospect of half of these being gradually phased out over time. For the interim period these systems will need to be working together. From an IT perspective this has proved a very challenging ongoing process." Translation: We will definitely throw a party on any day that one of our older IT systems finally kicks the bucket.

The article goes on to quote Heider saying: "With Schering-Plough’s merger with Organon we had approximately 20 interfaces to integrate. With the current project we are not only interfacing with legacy Merck systems, but we have also had to revise and modify those interfaces to the existing Schering-Plough systems." Translation: For the sake of productivity and sanity, we had no choice but to create our own interface consistency when we could not find it in the CTMS marketplace.

The text of the TouchBriefings article becomes a bit foggy at a certain point. Given Merck's fabled history and historically high standards of ethics, that is disappointing. Merck had an excellent opportunity to show less sophisticated companies how to handle the CTMS aspects of a large merger.

New Look & Feel

To a degree we had not understood, Merck is in the software trade and the user interface development business, modifying the look and feel of its organically developed and vendor-supplied software packages. It's not just a drug company. It's an interface company. Who knew?

The most eye-opening line in the TouchBriefings story describes the multi-stage process in which new trials were typically set up in the Impact CTMS. "Because Impact lacked certain interfaces, the data entry group is often required to input the same data into multiple systems, for example into a separate reference data repository." That's not the case with the Oracle system, the article notes.

Lack of Data

Merck, of course, is one of the better-run goliath firms in the industry. It's plausible that other companies have even more ornate and complex organizational diagrams for their CTMS systems. But one must ask: Is Merck's approach to the CTMS smart in 2012? Is it efficient? Is it a model for other firms? Is Merck's system modern?

It would be nice to know. We don't. There are simply insufficient details in the TouchBriefings article. d9A2t49mkex

Since drug companies typically require a list of questions for their executives to be submitted in advance of any interview, here are some additional talking points for anyone in the news media who might sit down with Mr. Heider. The same questions could also be helpful to purchasers of new- or retro-style CTMS.

ClinPage CTMS Questions

1) Is Merck's CTMS a Web 2.0 system? A relic from the 1990s? Can you supply a screenshot? Was it designed for clinical trials?

2) Please complete the following sentence: "Something our clin ops people and our data managers both love about this CTMS is _______________."

3) What percent of your CTMS budget is spent just on linking to other systems and revising user interfaces? How much time is needed to initiate a trial in the CTMS and connect it to safety, payment, randomization, drug supply and electronic data capture (EDC) systems?

4) How many new trials at Merck will have zero CTMS or limited CTMS functionality because of the cost and timeline penalties imposed by the CTMS?

5) What percentage of Merck's CTMS integration and customization projects finish on time? What is the typical cost for such a project?

6) Does your CTMS provide operational, real-time alerts and interactive reports for managers of every clinical trial? Do those reports show how and why individual clinical trial programs are over budget or behind schedule? Do your best managers actually use the CTMS? Or do they zealously guard a personal, private spreadsheet or old-fashioned human contacts to stay on top of their trial?

7) How easily can senior managers and top executives in the R&D organization find fresh, actionable, strategic information from your CTMS? What is an example of a type of report that validates the company's massive investment in its CTMS?

8) How readily will the CTMS surface massive repositories of data from new sources such as diaries, genomics, or imaging that live in specialized systems but still affect the overall progress of the study?

9) In an era of tough scrutiny of research budgets, would you ever advise a small pharma or biotech not to buy a CTMS?

This sort of questioning is fairly basic and obvious. But it would illuminate the entire CTMS niche with a general business sensibility that, until recently, helped to foster the R&D world's more innovative and entrepreneurial EDC sector. Introducing vitality and energy into the CTMS niche may be difficult, given such large and established companies involved in CTMS software. But CTMS technology will increase in importance as trials continue their unstoppable evolution toward greater complexity over larger areas of the globe.

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