Want science with that? That question hangs over the recent acquisition of 35-employee Fast Track Systems by Medidata Solutions, a leading electronic data capture (EDC) vendor.

The deal (but no price) was announced in March. It is an intriguing and potentially game-changing event in the clinical trial technology sector.

The fast-growing Medidata, after adamantly focusing on its core EDC specialty since 1999, has now diversified—buying a scientifically- and financially-oriented consultancy that helps sponsors refine protocols and negotiate increasingly labyrinthine contracts with sites and contract research organizations (CROs).

A New Bundle

It’s not yet clear if anyone in the sponsor community has an urgent desire to combine clinical trial design and EDC. Pure clinical individuals generally organize themselves by product class (device? small molecule? biologic?), therapeutic area, or even medical subspecialty. The protocol is considered an outgrowth of that, not something to be driven by mere dollars or software.

Indeed, some in the industry may regard the database-driven subtleties of EDC as little more than a procurement headache or, perhaps, a diversion from the intellectual aspects of clinical development.

But as industry-sponsored protocols founder and get dragged into the Wall Street Journal, as investigators abandon the industry in droves, as patients seem to be in hiding, as trial after trial misses its budget and timeline (or both), why not introduce new techniques into the design of clinical trials? Could it possibly hurt what the industry is doing?

Beyond EDC

Medidata CEO Tarek Sherif says a more full acceptance of EDC is leading to different customer needs. In the past, he reports, “people were just worried about getting the technology in place. Now that I know how to get the basics done, it’s ‘how do I optimize my design process?’ ”

The Fast Track acquisition gives him two new offices (in Pennsylvania and California), and allows him to combine the sharpening of a protocol with the building of a trial inside an EDC system. ”It’s a way for you to do your internal budgeting and planning in a much more structured way,” he says. “Rather than take a guess, as you would have in the past, you can have a more informed procurement process.”

Cost Databases

The Medidata applications for EDC and trial optimization are still separate. But Medidata says the building of an EDC project will be radically simplified by using the technology from Fast Track, with a single click leading to a less cumbersome setup of trials planned and optimized using Fast Track software.

Fast Track, for the record, had counted 10 of the top 15 sponsors in the pharmaceutical industry as customers. (Some of its personnel and financial backing were from Lilly.) The company built its services around a database of 1,400 indications, 27,000 protocols and a quarter of a million contracts and grants. It has another 4,000 sponsor-contract research organization contracts, based on 250 CROs around the world.

Medidata is using the word “transformational” a lot, and it came up again in Sherif’s remarks. He believes the combination of EDC and trial design will be unique. “It’s an entirely different level than where we were before. It’s transformational,” says Sherif. “You’re going from planning writing the protocol to implementation. Before, those were separate steps. You’re taking one step out of the process.”

Leveraging CDISC

One of the wrinkles in the Fast Track deal is that the firm is the only company certified to be able to generate structured protocol data guaranteed to conform to the Clinical Data Interchanges Standards Consortium (CDISC) ODM standard, a complement to Medidata’s expertise in forwarding the data in another CDISC standard for submissions. The firm is the only one certified to import and export ODM data in eight different ways.

Faithful adherence to the letter of the CDISC standards remains elusive in the pharmaceutical industry, where “standard” is defined so loosely as to violate any dictionary definition. (When the drug industry says “standard,” it means “recommendation,” not the bonafide standards for electrical outlets or USB plugs.)

Even so, the future ability to support clinical data standards a bit more strictly could be a major accelerator of clinical trials. If sponsors, technology and outsourcing firms were on the same page, if more elements of previous trials could be re-used, there are probably months of time and millions of dollars that could be whacked out of the process. Coupling data standards and protocol optimization is steep terrain that other firms will eventually traverse, with or without using the Medidata software or databases. Potentially significant efficiencies could be available to sponsors willing to reassess the massive process by which trials are designed and launched.

The Fast Track acquisition is also interesting in that it appears to present no competitive worries for CROs that Medidata would like to woo as customers. The best-positioned Fast Track competitor, ClearTrial (which we wrote about here), also has trial-planning services related to outsourcing.

The haphazard manner in which most trials begin, it’s fair to say, does cry out for rigor and discipline and line-by-line examination of budgets and protocols in a systematic way. That’s something both Fast Track and ClearTrial offer, and which in some cases can lead to more realistic timelines and budgets for all concerned.

Authoring + EDC

The former head of Fast Track, Ed Seguine, is now general manager of the trial planning solutions group at Medidata. He describes the company’s “Designer” software as a clinical trial-oriented, document-authoring application. Other trial-planning software, he says, requires human or manual interpretation of text. “They all depend on the study documents and interpretations of those documents,” he says. “What our tool does is put a structured way of putting the document so that all the other systems are also populated.”

The company’s databases and software, Seguine takes pains to say, are not used to arm-wrestle suppliers with the goal of extracting lower prices. Rather his firm has tried to provide line-by-line insight into projects that can become highly complex and involved. “There are so many moving variables in there,” he says of the typical trial protocol. “It’s a way of understanding your thought process.”

Another co-founder of Medidata, chief technology officer Glen de Vries, is a proponent of making things as easy as possible for sponsors. The marriage of the Medidata and Fast Track systems will expedite that typically lengthy study-setup process, he says. “It’s a complement to everything we’ve done in EDC. You can go from a structured protocol and flow all of that meta information directly into EDC and other downstream systems.”

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