Services Thinking for Life SciencesA strategic approach to clinical trial start ups |
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The clinical trials process is a lengthy one that involves multiple parties, including contract research organizations (CRO’s), site management organizations, study sponsors and clinicians. Key challenges include recruiting appropriate trial sites, patients and CRO’s; developing relationships with new sites and clinicians, and trial site startup (i.e., training, systems setup and access, regulatory process and documentation). Efficiency has also been hampered by a lack of necessary communication and relationship-building between involved parties.
Achieving rapid initiation for clinical partners has become more complicated throughout the years. While the trial process has grown more reliant on IT systems, many organizations retain manual and heavily paper-based processes that make initiation even more daunting. Research groups have become more reliant on outside research support and heightened security concerns and sensitivity have lengthened time to systems access - resulting in companies investing to create digitally secure and regulatory-compliant models. To exacerbate existing security concerns, current workarounds (email, shared workspaces, etc.) have introduced new risks.
The dynamic nature of relationships with clinical partners can widen the gap between business and IT solutions, challenging technology to provide support to core processes. Relationship management with partners requires sustainable and repeatable processes to build brand, scientific mind-share and brand loyalty.
To meet this challenge of closing the gap, we provide here a case study utilizing Deloitte’s Services Thinking approach. Services Thinking leverages time-tested components and tools that have come before: Service Oriented Architecture (SOA), Business Process Management (BPM), Enterprise Architecture, Change Management, Process Reengineering, Business Function and Process Deconstruction. Typically, results with any one of these components is not always enough - they are usually a piece of the answer, but often cannot stand alone. Services Thinking requires the marriage of SOA concepts with Business Value Mapping, Process Engineering, Enterprise Architecture, and human capital. In other words, this integration requires more than a change in technology, processes, or organizational structures. It requires an evolution in thinking. Services Thinking is designed to help companies in their efforts to bridge the complex boundaries between organizations, processes, and technologies and achieve the power to turn complexity into advantage. We believe the changing landscape of clinical research and development requires this kind of multi-pronged business and technology solution to begin addressing unnecessary complexity and manual steps plaguing trial startup and execution.
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Services Thinking: A Services Thinking Approach to Clinical Trial Start Ups
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