In 2013, an AstraZeneca (AZ) business decision was made to design and implement a new full service outsourcing (FSO) model to deliver around 40 percent of the late-stage development portfolio encompassing interventional studies for all therapeutic areas. A small cross-functional team was established, who used a quality-by-design approach, to ensure the model met the needs of the internal customers (e.g. drug program leads), but was also adaptable to the inevitable changing business requirements.
The key must-have customer and business requirements included clinical studies that needed to consistently deliver to agreed time, cost and quality; the ways of working needed to be clear and simple, and not require support of an alliance management (AM) organization. For example, an AZ project leader would be responsible for oversight and communication directly with the CRO (Contract Research Organization) study team rather than via an AM organization.
Back to Basics FSO delivery: Model Overview and Principles
The team’s work resulted in the design of a “back to basics” operating model which was named SCOUT (Solution for Clinical Trial Outsourcing). The multiple features of the SCOUT model (see Fig. 1) included:
- Study team resided in the CRO (i.e. no sponsor ‘mirror teams’)
- Competitive study allocation process
- Alliance management (AM)organization not needed
- An underpinning of functional subject matter experts driving continuous improvement and innovation to ensure model adapted to changing business needs
Following senior leadership endorsement of the SCOUT model, the team led the selection of the SCOUT CRO partners and subsequent due diligence. Three CROs were selected with capabilities and performance that aligned with the needs of the rapidly growing late-stage portfolio. In contrast to the previous model (Fig. 2), SCOUT-selected CROs were not therapeutically aligned, and AZ project teams were central to the competitive allocation process to ensure the selected CRO was the best fit to the project team study needs.
Figure 1: SCOUT features and summary of principles
Challenges in Implementing the Model
In mid-2014, we initiated implementation of the SCOUT model for new studies from the rapidly expanding late-stage portfolio. In terms of the challenges in implementing the SCOUT model, they fell into four main categories:
Firstly, a significant organizational change was needed from a dedicated, large (approximately 50 staff) and very experienced AM organization to a model where outsourcing management was embedded in the organization. This required a capability build in outsourcingsupported by a small center of excellence (two staff).
Secondly, due to legacy studies, parallel management of two operating models was needed. Legacy ongoing studies were kept under the previous model, whereas new studies started under SCOUT with no down time to implement the new model.
Thirdly, managing senior leadership expectations that the SCOUT model would deliver around 40 percent of a rapidly expanding late-stage portfolio across all therapeutic areas. In addition, many of the studies were both high profile and high priority within the portfolio.
Fourthly, with the selection of three CROs that provided key benefits (e.g. capacity, competition, capability, AZ project team choice), there was also the challenge of establishing a single way of working with three CROs using their own processes and systems to ensure operational excellence.
Figure 2. Key differences between SCOUT and previous model
Collaborative Approach to Establish Ways of Working with Multiple Partners
The SCOUT model was implemented in mid-2014 with the simple goal of maximizing the performance of clinical trial delivery in terms of speed, quality, cost and inspection readiness. As Figure 3 indicates, we focused on three implementation elements in parallel: operating model, process and people. Although there have been many challenges, implementation was considered a success with more than 30 active studies under SCOUT at this time, with key goals achieved for all three implementation elements:
- Operating Model: Competitive allocation of study to CROs in conjunction with a clear and effective commercial framework to drive performance
- Processes: Default position is the CROs use their own processes and technologies to deliver AZ study level requirements and ensure operational excellence
- People: Outsourcing capability resides in the project team organization and we have seen the rapid development of that organizational capability
Figure 3: Overview of SCOUT implementation elements
One of the key contributory elements in successful implementation was the cross-CRO and AZ collaborative forum named Akela, which was formed very early in implementation. A key principle of Akela was that the CROs worked collaboratively with each other to help achieve AZ’s goal of delivering our late-stage clinical trials to the industry’s upper quartile of performance levels (time, cost, quality, and inspection readiness).
Akela was established with three initial objectives. Firstly, provide a single way of working enabling studies to deliver to time, cost quality, and be inspection ready. Secondly, enable CROs to utilize their own processes and systems while meeting AZ requirements. Thirdly, develop a network of AZ/CRO functional SMEs to support the ways of working.
Akela was an investment by both AZ and the three CROs and therefore it was important that tangible outputs were delivered to provide a ‘return on investment.’ The initial outputs included a single common list of required services (i.e. description of services) not only used as a master service agreement (MSA) key schedule, but also provided a “ways of working”guide for AZ and CROs staff. In addition, Akela established a single set of performance measures (time, cost and quality) with targets, which underpinned portfolio level governance and provided another key MSA schedule.
As shown in Figure 4, Akela was established at the heart of SCOUT governance with an interface with the functional and governance teams supporting the model. This included, the SME network, which was established by Akela to ensure SMEs from the CROs and AZ work collaboratively to support SCOUT study delivery and drive continuous improvement. In addition, as Akela team members, we are alsopart of the AZ/CRO portfolio level governance teams, and therefore had a key role in resolving cross-CRO escalated issues identified in the governance team. There was also a strong connectivity with the SCOUT Governance Team (SGT), which was responsible for the SCOUT model being fit for purpose and for the performance management of the SCOUT portfolio.
Due to the success of Akela, the forum continued after the implementation phase to identify solutions to further enhance the SCOUT ways of working. For example, Akela designed and communicated the issue escalation process, and sponsored a program to improve the transfer of data and information between AZ and the three CROs.
Figure 4: Cross CRO/AZ forum (Akela) interactions with SCOUT governance and functions
Although there are numerous reports on the merits of different outsourcing models, a critical initial step in any sponsor clinical development organization is to determine who the customers are and what their must-have requirements are. In this case study, these customer requirements formed the guiding principles to design and implement the SCOUT model. For another sponsor organization, there may be different requirements and therefore the selected model will likely be different to the SCOUT model.
The Akela team demonstrated that, given the right environment (e.g. clear goals, transparency, trust), CROs can collaborate with each other and will provide honest but constructive feedback to sponsor organizations. It’s worth remembering that CROs work with multiple sponsors and therefore have more experience than a single sponsor and therefore there is great aopportunity to utilize CROs’ extensive experience in a sponsor clinical development organization.
Traditional thought is that the sponsor is the sole customer and the CRO the supplier. The SCOUT work has shown us that the roles will be often reversed in the clinical study and it’s important not to be afraid of using the customer and supplier words. For example, in study set up, the sponsor is often the supplier to the CRO and the CRO cannot progress the study if the sponsor does provide key inputs (e.g. clinical protocol, study site list, etc). We can use these words which are clear, unambiguous and describe the reality of engagements throughout the study between the CROs and sponsor.
A question we are frequently asked is how do you ensure good partnership behavior in a CRO/sponsor relationship? The simple approach we took in SCOUT was to encourage our staff to use the same values and behaviors promoted in AZ with our CRO colleagues and take a ‘one team’ approach.
The final learning is that successful implementation can only happen if you invest in sufficient staff education and training to drive the necessary change management. In addition, don’t underestimate the need for senior leaders to lead by example and drive behavioral change, across all organizations.
What Next for the Model to Ensure it Delivers the Changing Business Needs
As a key must-have for the model was SCOUT would continually evolve to align with the changing business need, and therefore we recently completed a model review with input from key customers and stakeholders. This review highlighted some new business requirements that have resulted in a number of modifications including:
- Increase SCOUT scope to include AZ subsidiary companies who previously worked with their own selected CROs and therefore reduce the number of CROs and align ways of working
- Modified SCOUT governance and associated KPIs (key performance indicators), using our learnings to enhance both these areas to ensure we continue to drive for industry leading performance (time, cost, quality and inspection readiness)
- Strategic approach to sourcing including programlevel sourcing decisions (compared to individual study level sourcing decisions)
- Early engagement, prior to sourcing decision (i.e.deliver internally or outsource) with CROs to obtain input to ensure the sourcing decisions are based on the capabilities of the CROs vs. the needs of the program or project
- Early engagement with CROs, prior to program/study award, to obtain input on study design, operational risks and mitigation
Although the review highlighted some key changes, the underpinning SCOUT principles were maintained with senior leader support. This provides confidence that the model will continue to adapt and evolve to ensure the delivery of outsourced studies is optimized and strives for industry leading performance.
Dr Stephen M. Walker
Although the SCOUT team was a small and ever-changing team, it is important to acknowledge all the people at AZ and our CRO partners who made a significant contribution to the SCOUT model that continues to flourish and evolve. I cannot include everyone but wanted to acknowledge the following:
AstraZeneca: Rupert Dixon, Nadia Turner, Kate Gibb, Vince Mazzella, Karen Sanville, Terry Grass, Andy Parrett, Vicki Connelly, Doug Schantz, David Wheeler
CRO partners: Jason Packwood, Mark Clegg, Susan O’Grady, Sarah Taylor, Julia Morris