In today’s world of significant pressure to deliver cost effective clinical trials in a highly competitive and fast paced environment, sponsors face many competing influences in developing the appropriate sourcing strategy that balances risk, reward and cost.
Since its inception, and more so in recent years, compliance with ICH E6 R2 and other regulatory requirements has been one of the greatest drivers of the cost of clinical studies. Sponsors continue to be faced with increasing costs of compliance and mounting pressure to deliver exceptionally clean data in this highly regulated industry. One example of this is the most recent updates to ICH E6 R2 relating to the oversight requirements which, unless managed carefully, can result in increasing costs resulting from duplication of effort across the sponsor and service providers.
Adherence to the high standards of quality and compliance expected prior to any approval has to remain at the forefront of the conduct of every study, however, a well thought out sourcing strategy and the implementation of a trial oversight plan can significantly help in identifying the potential for duplication of resources and the associated cost redundancy.
Today there are multiple variations of sourcing models in the industry, ranging from utilization of niche providers focused on patient recruitment, Functional Service Providers (FSP) supporting specific areas of activity to comprehensive end-to-end outsourcing of all functions/ services for a clinical trial. Unless strategically set up, and well managed, any of these structures can result in a considerable increase in cost, both direct and indirect, due to duplication of activities across one or more of the service providers and internal sponsor resources.
Value Driven Sourcing Strategy and Project Management
Initially, it is important for any sponsor to understand and acknowledge their internal areas of strengths and weaknesses, defining what you want to be core versus non-core activities, as this should be a significant driver of determining what activities will be conducted in-house and which services should be sourced to external providers.
It is important for sponsors to fully evaluate their sourcing strategy based on the current and planned portfolio to understand the operational delivery requirements and the business/financial impacts of the strategy. Over the past three decades the industry has experienced a strong tendency to a cyclical approach to sourcing models, however in order to fully recognize the value of both internal resources and the external knowledge and resources service providers can add, the benefits of an established sourcing strategy are only fully realized over a period of time, closely linked to the timeline for a development program. For example, a smaller biotech sponsor with extreme scientific and statistical depth, utilizing a mixed model approach with multiple providers, will require a team of talented program managers to provide the necessary oversight of their portfolio. If, however, after two years the sourcing model is changed to an end-to-end single provider approach the role of the program manager becomes internally focused, requiring a different skill set.
Developing the appropriate sourcing strategy requires a deep dive into the sponsor organization to include an evaluation of the portfolio, review of current personnel, competencies, roles and responsibilities, and commitment across the entire organization to implement the sourcing strategy. Consideration of all of the above will help to drive the most appropriate sourcing strategy for success. As mentioned in the introduction, there are a multitude of sourcing models today, which are subsequently supported by a variety of different service providers. There are so many choices in service providers it can be difficult to maneuver through the options, from niche providers to small to midsize clinical research organizations to the ‘mega-size’ providers who now provide end-to-end solutions for all product development activities. It is, therefore, critically important to fully understand the internal requirements before reaching out to potential providers during a selection process.
During recent discussions with a number of different sponsors covering a variety of therapeutic areas, the number of service providers supporting a single clinical trial ranges widely from a single provider to greater than thirty providers supporting a single study (excluding the study sites).
Given the challenges that a very high number of third party service providers can create it is important to understand the implications of working in this type of sourcing model. Particularly with the ICH E6 R2 requirements for oversight, it is important to evaluate the internal resources required to manage this at the sponsor. This is one of a number of considerations that should be evaluated when the sponsor is developing the sourcing strategy for their portfolio.
There are pros and cons to all of the sourcing models, ranging from the challenges of having a single provider to the complexity of multiple providers. The key is to have the “right” fit that brings highest value for the sponsor and to have an internal team who are able to manage the providers/partner.
An important factor that should not be ignored in developing the sourcing model is the associated contracting strategy. This should be developed in parallel to streamline the business operation’s activities (budgets, contracts, forecasts) with the selected sourcing model. For example, when working with multiple providers in a mixed provider model, streamlining the business operation’s activities with standard templates that can be utilized across multiple providers can result in internal efficiencies. Standardizing the review of budgets and contracts by having sponsor defined templates can also help reduce the financial impact of multiple providers.
Another area that can provide considerable benefit to the sponsors is the ability to link service provider financial forecasting to the internal sponsor budget process, as this can enable maximized value of annual budgets across the development portfolio.
“Tools” to Support Risk Mitigation and Resource Efficiency
Once a sourcing strategy has been defined, it is important to ensure risk mitigation during the operational delivery of the clinical study. This can be facilitated by a set of documents that support the delivery of the study in an ‘inspection ready’ state, provide for oversight and that will highlight any duplication of resources. The following are examples of the documents that can be utilized, terminology agnostic, however these are generally accepted terms.
- Trial oversight plan (TOP) – The TOP documents the sponsor’s oversight of any trial related duties and or functions carried out on its behalf. Note: This can vary in complexity from sponsor oversight of activities at study sites conducted internally to a comprehensive plan for the oversight of one or more service providers conducting the study.
- Integrated project management plan (iPMP) – Every study should have some level of iPMP in place whether it is fully insourced or partially/wholly outsourced. This will document the necessary cross-functional linkages required to deliver the study. The iPMP describes how the trial will be conducted with a focus on quality, communication and escalation. This document should be developed cross-functionally and reviewed at the initial study “kick-off” meeting. This should be a “live” document remaining current throughout the study duration. The iPMP will incorporate the following:
- Quality Management Plan
- Communication Plan
- Clinical Operations Plan
- Medical Monitoring/Medical Review Plan
- Safety Management Plan
- Risk Management Plan
- Statistical Analysis Plan
- Integrated Data Review Plan
- Operations manual – This is a description of the interfaces for responsibilities and accountabilities across all parties providing services for the conduct of the study, by function, in accordance with the terms of the contract and intended operating model.
- Service provider governance plan – It is important to have a governance plan in place for all service providers participating in the study as this will help to ensure the following principles are maintained:
- Create an environment of transparency and trust between companies.
- Drive opportunity for both strategic and tactical relationship and performance management.
- Ensure agile teams can make decisions in a reasonable period of time, empowering groups to move deliverables and decisions forward.
- Active study management to facilitate and monitor service provider activities.
- Timely communication of key decisions (up, down and across).
- Encourage proactive escalation and timely resolution of issues.
With inspection readiness, the first two documents are non-negotiable in some form, while the second two become more relevant with the growth and maturity of the relationship with the service providers. As such, identifying service providers that will work as partners to develop these tools during the early stages of a study will drive value and greater opportunity for a successful delivery of the portfolio.
Sourcing Strategies for Tomorrow – Are They Value-Added?
As we reflect on the past three decades of clinical research, we have seen very little change in the structure of development teams. These teams have typically been led by a project management lead, with other team members representing the core functions of clinical operations, biometrics (data management, statistical analysis), medical/scientific (incorporating drug safety), quality and regulatory. Enabling functions have included technology, finance, logistics and drug supply, commercial/branding and business operations (outsourcing, procurement, budgets and contracts).
However, with the changes in the industry, including e-clinical, digital innovation, the implementation of virtual studies, etc., this challenges the status quo of today’s team structure. While current skills will continue to be required, does the team structure need to be addressed to support the changing dynamic of clinical studies and perhaps more importantly, looking beyond the individual clinical study to product development?
We are experiencing a change with many of the larger Clinical Research Organizations (CRO’s) having transitioned beyond the historic suite of services to include product development planning through post-launch services, offering consulting and a variety of additional services to continue to drive the innovative changes in product development. As biopharma companies develop their sourcing strategies there are now “new” organizations to consider that offer integrated biopharmaceutical solutions. With these new BSO’s (Biopharmaceutical Solutions Organizations), is this the time to challenge the structure and competency models of development teams in which the core functions become scientific strategy (MD, Statistician, Regulatory), e-Clinical/digital/innovation, commercial strategy/brand lead and business operations, with enabling functions of clinical operations, biometrics, drug safety, logistics (regulatory, clinical trial supply) and vendor strategy?
We are experiencing a change with many of the larger Clinical Research Organizations (CRO’s) having transitioned beyond the historic suite of services to include product development planning through post-launch services, offering consulting and a variety of additional services to continue to drive the innovative changes in product development. As biopharma companies develop their sourcing strategies there are now “new” organizations to consider that offer integrated biopharmaceutical solutions.
With these new BSO’s (Biopharmaceutical Solutions Organizations), is this the time to challenge the structure and competency models of development teams in which the core functions become scientific strategy (MD, Statistician, Regulatory), e-Clinical/digital/innovation, commercial strategy/brand lead and business operations, with enabling functions of clinical operations, biometrics, drug safety, logistics (regulatory, clinical trial supply) and vendor strategy?
Focusing in on the value-add strengths of the service providers and setting up a transparent working structure will help to achieve positive results for all parties.
I appreciate that this may be provocative, however, in an industry where we have seen very little change in the sourcing activities (outsourcing, procurement, budgeting and contracting), isn’t it time to challenge that and work towards supporting the innovative solutions – solutions that serve our ultimate customer, the patient?