Recently, a growing number of clinical trials, both in scale and scope, are creating a paradigmatic shift in clinical supply operations. Moreover, the increasing complexity and scale of clinical trials are posing new challenges to clinical supply chains. As a result, companies have started to look more at the organisational structure of clinical trials, from process designs to the suitability of IT systems. In addition, resource and skills development are being reviewed as they play critical roles. The intensity of this shift and related response could vary depending on the sourcing strategies for operations. Our discussion is primarily based on observations from an organisation insourcing the majority of the operations.

Function OrientedProject Oriented

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The increase in scale and scope of clinical trials is ubiquitous, bringing supply budgets constantly under pressure. Hence in recent times there is a sharp focus on flexible yet cost-effective clinical supply chain management. This has drawn attention to the idea of organizing through process or function. Traditionally one or two coordinators manage each clinical trial from protocol execution, through production, logistics planning and trial closure. Such a project oriented approach certainly has some advantages, from end-to-end control to process adaptation according to trial designs. Conversely, the increasing number and complexity of clinical trials will demand a need for cross-trial coordination and prioritisation. A functional approach, which would serve well in achieving cross-trial coordination as well as efficiencies of scale, could cause suboptimal performance of individual functions and a shortfall in achieving service agreements for the end-to-end chain. A Matrix approach is a hybrid of project oriented and function oriented approaches, which diminishes the vertical structure of functional and creates a more horizontal structure which allows the spread of information across task boundaries.

The Pros and Cons

The matrix approach can be illustrated as business Lego; functional units that can quickly be reorganized into new value chains. A central function to monitor performance of individual functions at an operational as well as a tactical level, will allow companies to keep the whole chain in focus and deliver according to the service agreements. For effectively managing clinical supplies with a matrix approach, IT systems play a critical role in facilitating transparency across different levels of the organisation as well as the different functions. Success of the matrix approach depends on the ability to make the relevant information readily available across organisational and functional boundaries. Agility without compromising quality could be facilitated by standardizing certain functional routine tasks and appropriately designed IT systems could help in achieving this.

Factors such as patient randomisation, strict requirements for product blinding and GxP requirements set the clinical supply chain apart from other industries. Safety of patients is paramount while managing the clinical supply chain, which not only expects product traceability but also close to 100% service levels. Although a Project wise approach assures end-to-end control in such a demanding environment, it may fail in utilizing functional knowledge available across the breadth of an organization, which may encourage customized computing support tools and non-standard data management. A Functional approach depends on development of functional expertise which may encourage development of home brewed supporting tools in individual units. The ability to look across functional units can be a game changer in achieving end-to-end control while taking advantage of functional expertise. Best in class commercial off-the-shelf systems can be the key to achieving such cross functional transparency. To achieve overall intelligence about the chain it is imperative these systems follow industry standards and strict master data discipline is maintained.

Critical success factors:

  • Alignment between Business and IT strategies
  • Strong Executive Sponsorship and consistent management support
  • Organisational change management
  • Clearly defined roles and responsibilities
  • Training across the organisation
  • Master data Control

To deal with changing environments, a business strategy needs to not only propose delivery expectations and success criteria, but also direct the change in operation to achieve that. Aligning an IT strategy with a business strategy is critical to the execution of a project management approach. Strong management sponsorship will help in emphasizing common goals while developing functional units and integrating these across the organisation. As much as performance of functional units is necessary in achieving desired results, so is focus on operational and tactical monitoring at all levels of organisation.

Systems Characteristics vs Data Characteristics

For successful implementation of the IT strategy it is just as important to identify personnel with the necessary skill set as well as a mindset for the individual functions. Specialists with functional expertise as well as proficiency in specific systems will facilitate efficient delivery from functions, while managers equipped with business intelligence providing cross functional transparency will ensure seamless execution of projects. Clearly defined roles and responsibilities will help in optimal design, implementation and use of systems as intended. Continuous training in systems will further ensure the systems are fulfilling their purpose according to the respective roles, which will create a solid standardized platform in an otherwise dynamic environment of clinical supply chains. For the sake of transparency, an ideal solution would be to have a single system platform across all functions. For a variety of reasons this is not always feasible and data integrity across platforms can only be achieved through strict master data discipline. Ensuring master data in control is extremely critical, especially when considering regulatory and patient safety implications for the clinical supply chain.

Organisations managing clinical supply chains are challenged by the increasing number of trials and their complexity. We believe that a matrix organisation harnessing the advantages of both project and functional oriented project management will live up to the challenge. The creation of standardized and controlled IT platforms play a critical role in anchoring such a hybrid management approach which requires seamless information sharing across the organisation.

Project Management: A managerial Approach, Meredith and Mantel, 2012. Pages 175-187. ISBN: 9780470533024