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The Clinical Trial Dilemma

By Robert Webber

Feb. 12, 2007 | A typical Clinical Operations group is charged with collecting myriad data points and status tracking reports, aided by specialty software applications. There are many possible approaches for data integration within these applications, and with other enterprise software, each with significant business and technical implications. So, how do the IT and clinical operations departments ensure they implement the best overall solution for the company?

While vendors offer many technologies to tackle integration needs, some of these offerings may also be tied to marketing strategies that could impair a company’s ability to switch vendors, or limit future purchase choices. Available integration technology options need to be fully examined in view of the key business drivers (see Table) that include cost of investment and ongoing support and maintenance.

Some possible approaches include:

• Application Program Interface (API)
An API provides access to internal software functions. Companies can develop integration software through functionality made available via the API. This type of integration model calls for the highest skill level, usually requiring internal developers with experience in object-oriented design techniques and software development languages like C++ or Java. Internal development and support costs are higher because of the need for classical software development life cycles spanning requirements, detailed design, coding, and testing phases. The IT department is totally dependent upon what the vendor decides to expose and/or maintain in terms of the API, and vendor-introduced changes to the API can ripple through legacy integration software.

• Connectors/Adaptors
This option is similar to an API, but the vendor provides specific integration modules that can be incorporated within user-developed software. Connectors and adaptors have somewhat less flexibility than a general API in that a finite set of integration options is available. Vendor dependence is still high because the vendor controls availability of specific connectors or adaptors. Simpler programming languages like Visual Basic can be used, but a standard software development life cycle is still required.

• Web Services
Essentially an API based upon an industry standard for exchanging data over the web, communication mechanism is standard, though some programming is generally necessary to generate and accept data.

• Database Standards
Standards allow access to different database management systems. The most common standard is ODBC (Open Database Connectivity). Although the method for interchange of data is standardized, programming is necessary to control interchange of the data.

Database and web services integration choices are both generally superior to an API or connector/adaptor approach because of a level of standardization. However, options like ODBC and web services  provide standards at the message transport level, and are not independent of database contents or application methods.

• Graphical Workflow
This technology links common software functions, or process modules, that can be “dragged and dropped” and connected in the desired operational sequence via a graphical editor. This simple approach has the added benefit that business rules can be added or customized “on the fly” by people with minimal programming skill. However, the available set of integration modules is still generally controlled and sold separately by the vendor.

• Graphical Workflow with Software Development Kit (SDK)
A Software Development Kit (SDK) provides libraries, templates, and tools for the development of graphical process modules by in-house programmers. An added SDK empowers the IT department to create their own integration modules, which can then be linked into workflow by people with lower programming skills. Standard process modules can always be purchased from the vendor, but the IT department now has the additional ability to develop new modules internally.

Whichever integration technology drives your business, understanding both the IT and Clinical Operations department’s needs and expectations is crucial in avoiding an unnecessary dilemma in the decision making process. When facing a request to add another application to the IT enviroment, take your basic integration options and their consequences into consideration.

Robert Webber is president and CEO of TranSenda International. Email:

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