The Era of Architecture

Globally Connected Service-Oriented Architectures as Key Enablers of a Life Sciences Industry Architecture

Part 3 of a three-part series
By John Shipway 

In prior articles, we’ve discussed the boundaries that are encountered when working within the life sciences industry:

• Organizational – working across companies and their respective functions, people, policies and processes.
• Geographical – working across disparate locations and cultures around the world.
• Technology infrastructure – working across different networks and security models.
• Software – working across different information systems and different application server platforms.
• Scientific – working across different research domains and designs.

These boundaries present huge challenges to an industry that is under increasing pressure to bring new compounds to market more quickly and to collaborate effectively with business partners, outsourced research organizations, offshore resources, organizations that have been recently acquired and governmental agencies. In many cases, all of the parties that are involved in the process of bringing a drug to market do not share a corporate network, an electronic data capture tool, a clinical data repository, a statistical computing environment or a clinical reporting system. This lack of connectedness begs for a new, cross-enterprise industry model of organizing the IT systems that are used in the drug development process.

A Life Sciences Industry Architecture
An architecture represents the fundamental organization of a system, the principles governing its design, the makeup of its components, the relationships between components, and the methods of communication between components and other systems.  Properly applied enterprise architecture can facilitate the crossing of boundaries at the scientific, software, technology infrastructure and geographical levels within an organization. To truly cross organizational (enterprise to enterprise) boundaries in a repeatable, consistent and timely manner, an industry architecture is needed. There are two key enablers of a life sciences industry architecture:  service orientation and ubiquitous Internet connectivity.

Service-Oriented Architectures 
A service-oriented architecture (SOA) is a method of designing a system in terms of services. Services are self-contained software appliances that are connected to a network and have explicitly defined interfaces for their use. Services adhere to the following tenets:

• Services have formal, explicit boundaries, in which no assumptions are made regarding their implementation. 
• Services share schemas and contracts only, not implementation. 
• Services communicate over an agreed-upon protocol and payload format. 
• Services are autonomous; they are designed to be deployed, managed and versioned independently. 
• Services determine compatibility based on policy, which is a machine-readable description of a service’s capabilities and requirements.

Independent implementation is the key factor enabling services to leapfrog over prior attempts to have truly distributed, interoperable component platforms. The systems and technology deployed in an SOA environment can truly grow and evolve independently in “Internet time” since no one vendor represents a bottleneck for progress. Virtually all commercial software vendors are constructing their solutions in such a way that they can participate within an SOA. Namely, they are exposing their core functionality as a set of Web services; they are allowing for the consumption of other vendors’ Web services within their application’s workflow; and they are allowing for some flexibility in a customer’s choice of service implementation at deployment time (e.g., a pluggable security service). As electronic data capture applications, clinical data management systems, clinical data integration solutions, and statistical computing and reporting applications move toward a service-oriented model, and as life sciences companies deploy these services in such a way that they can be securely accessed over the Internet, an entirely new set of capabilities has evolved:

• The process and workflow of moving a compound from discovery to launch can be modeled and managed in software, with collaborators participating from numerous organizations, geographies and disciplines.
• A unified repository of knowledge spans scientific discovery, pre-clinical phases, clinical trains, manufacturing, marketing and compliance.
• Labs, physician partners and CROs can exchange patient data in near real time during clinical trials.
• Scientists can routinely view an aggregated archive of research and industry information related to their work. 

An Example: Clinical Data Integration
As an example, let us examine a clinical data integration solution in which a sponsor is aggregating clinical data from a business partner, an offshore lab, numerous physician sites and a CRO. 

Each entity is using its own applications and data capture solutions running on a variety of workstations, devices, operating systems and application platforms. The sponsor has deployed a set of Web services within its corporate DMZ to allow its various business partners and collaborating entities to interface their applications and data into the sponsor clinical data workflow process. This outward-facing Web services layer is the key ingredient that facilitates the collapsing of organizational boundaries and enables an industry architecture.
In addition, the sponsor has deployed a set of inward-facing Web services to enable its own enterprise architecture. Numerous internal processes, ERP systems, manufacturing systems and supply chain systems that are SOA enabled need not travel outside the corporate firewall in order to access the company’s services layer. The bits running inside the inward-facing service processes are identical to those in the outward-facing services layer; only the security policy governing access to the service need be changed. The same investment can be leveraged to integrate systems, processes, people and data both within the enterprise as well as between enterprises.

Conclusion
In a business climate that is increasingly outsourcing work to reduce operational costs, enterprises have an unprecedented need to share information globally and collaborate on business processes. The ubiquity of high-speed Internet connections and trusted encryption protocols have enabled the adoption of SOA-based business solutions accessed across the globe over secure public networks. Technology and industry standards consortiums such as CDISC, the W3C, OASIS and WS-I are actively promoting protocol, workflow, packaging and content standards that continue to make enterprise-to-enterprise interoperability over the Internet a more seamless proposition.    SOA is maturing at a time when the life sciences industry can use it as a key pillar of an industry architecture that will allow organizations to innovate across boundaries and bring drugs to market more quickly, more profitably and with higher quality.