Since clinical trial outsourcing emerged in the late-20th century, there have been significant shifts in its approach and benefits. Driven by evolving regulatory requirements, technological advancements, and changing business needs, outsourcing in clinical trials has allowed organisations to enhance efficiency and reduce costs.
If you already understand outsourcing models in detail, then it is worth skipping down to the “why” of required change in clinical trial outsourcing below.
In this blog post, I’ll explore the development of outsourcing in clinical trials over time and its impact on the industry. Including developing future models of outsourcing in clinical trials.
1st Generation Outsourcing: Cost Reduction Focus
1st Generation Outsourcing: Managing Demand and Niche Services
Definition:
The first generation of outsourcing also known as “Spot Outsourcing” Aimed to meet strain on demand and to fill gaps in internal capabilities with niche services. This phase ran from the late 1980s and early 2000s, was used to manage peaks and troughs in workload rather than make cost savings.
Key Characteristics:
- Outsourcing was primarily decentralised and used to meet sudden spikes in demand or to fill gaps in expertise that were not available internally.
- Services were contracted for specific tasks or phases of the clinical trial process.
- Specialized services were outsourced to vendors with expertise in particular areas, such as data analysis, patient recruitment, or regulatory submissions
- Limited strategic collaboration or integration with internal processes.
Example:
A pharmaceutical company, lacking in-house imaging capabilities for a Phase II oncology trial, contracts a specialised imaging firm for this specific task. The firm provides high-quality imaging reports and integrates data into the trial database, ensuring regulatory compliance. Once the imaging is complete, the contract ends, addressing the immediate need efficiently without long-term commitments.
2nd Generation of Outsourcing
Emerging in the late 1990s and early 2000s, driven by companies looking to Greater co-ordination of outsourcing activities across functions, further focus on functional specific needs and solutions
Key Characteristics:
- Move to full-service outsourcing.
- Centralisation of outsourcing groups giving greater visibility of total spend.
- Move to FSP and off-shoring, this involved moving jobs to countries with lower labour costs to save money on salaries and benefits.
- Standardised Services: Services were standardised, with little customisation for individual client needs.
Example:
Offshoring basic IT support and data entry tasks to countries with lower labor costs, such as India and the Philippines. This involved transcribing paper-based clinical trial data into electronic databases and maintaining IT infrastructure. While this approach significantly cut operational expenses and allowed for quick scalability, it faced challenges like ensuring data accuracy, overcoming communication barriers, and integrating outsourced tasks with core trial activities.
3rd Generation Outsourcing
The 3rd generation of outsourcing emerged in the late mid 2000s, focusing not only on cost reduction but also on improving efficiency and quality. This phase saw a shift towards more strategic outsourcing relationships.
Key Characteristics:
- Efficiency and Quality: Emphasis on improving operational efficiency and service quality, in addition to cost savings.
- Partnership Approach: Evolved from transactional relationships to more strategic partnerships with vendors.
- Process Optimisation: Outsourcing aimed at optimising business processes, leveraging the vendor’s expertise and technology.
- Service-Level Agreements (SLAs): Introduction of SLAs to ensure that vendors met specific performance and quality standards.
Example:
CRO Partnerships: Clinical trial sponsors partner with Contract Research Organisations (CROs) to manage various aspects of clinical trials, such as patient recruitment, data management, and regulatory compliance. This collaboration leverages the CRO’s expertise and infrastructure for efficient trial execution.
Focus on Quality and Compliance: Ensuring high-quality data collection and strict adherence to Good Clinical Practice (GCP) standards are critical. Sponsors implement rigorous quality control measures and continuous training programs for both in-house staff and CRO teams to maintain compliance with regulatory requirements.
Integrated Services: CROs provide integrated services that combine multiple functions, including clinical monitoring, data management, and biostatistics, into a one-stop solution for clinical trial management. This integration streamlines processes and reduces the complexity of managing multiple vendors.
This third-generation outsourcing model enhances efficiency, ensures compliance, and facilitates successful trial completion by leveraging specialised CRO expertise, integrating services, and implementing robust quality and risk management practices.
4th Generation Outsourcing: Strategic and Transformational[RA1]
Definition:
At this point in time different companies have been cycling through these models with varied amounts of success but no real innovation in approach to transform the engagement or the outcomes.
The industry is currently at a point where it is crying out for new solutions in order to address increased pressures on R&D efficiency and effectiveness. 4C associates have succinctly addressed the need for change in clinical trial outsourcing practices, identifying the financial and macroeconomic pressures that are driving this need.
It is commonly agreed that the 4th generation of outsourcing needs to focus on hybrid models of outsourcing that are dependent on, and structured around, specific the project requirements. 4C have proposed a novel model derived from other industries, such as IT in the 2010s, which they call the Cellular Services Model.
It focuses on strategic transformation, leveraging specialised, flexible, and scalable teams to drive innovation and competitive advantage. These Teams should all work to project focused agreements between each service provider ensuring that the collaboration and quality in the delivery and relationships benefits all parties.
Key Characteristics:
- Strategic Focus: Outsourcing is used as a strategic tool to drive business transformation and innovation.
- Specialised Teams: Utilises small, specialised teams (cells) dedicated to specific tasks or processes.
- Flexibility and Scalability: High adaptability to changing business needs, with the ability to scale resources up or down as required.
- Collaborative Partnerships: Strong emphasis on collaboration and partnership between the client and service providers.
- Advanced Technology: Leveraging advanced technologies like automation, AI, and predictive analytics to enhance efficiency and outcomes.
Example:
Cellular Services Model (CSM) Implementation: Clinical trial sponsors adopt the Cellular Services Model, which involves creating small, specialised teams (cells) dedicated to specific tasks within the clinical trial process.
In an outsourcing strategy for clinical trials, each cell is composed of specialised roles from different service provider organisations. Each service provider brings its expertise to form a cohesive, efficient, and autonomous team responsible for specific aspects of the clinical trial.
Enhanced Communication and Collaboration: Frequent and structured communication protocols are established, including regular coordination meetings and the use of collaboration tools. This ensures seamless interaction and alignment among all stakeholders, including sponsors, CROs, and specialised cells.
Tailored Quality and Compliance Measures: Each cell is responsible for maintaining high standards of quality and compliance, tailored to their specific function. Continuous training and rigorous quality assurance programs are implemented to ensure adherence to Good Clinical Practice (GCP) and other regulatory requirements.
Flexible and Scalable Resource Allocation: Resources are allocated dynamically based on project needs, allowing for rapid scaling up or down. This flexibility ensures that each cell operates efficiently and can adapt to changing trial requirements without compromising quality or timelines.
Performance-Based Incentives and Accountability: Performance metrics and key performance indicators (KPIs) are established for each cell, with clear accountability for outcomes. Performance-based incentives are used to motivate teams, ensuring high-quality deliverables and timely project completion.
Strategic Partnership and Collaboration: The relationship between Sponsors and service providers is more collaborative and strategic, focusing on shared goals and mutual success. This partnership model reduces power struggles and promotes a cooperative approach to achieving trial objectives.
Why Pharma Must Adopt the Cellular Services Model in Clinical Trials
With a 1 day delay in clinical trials re-analysed recently by Applied Clinical Trials at ~$500k and dwindling ROI on R&D spend analysed in 2023 in Deloitte, it is clear that something has to change in order to drive new efficiencies in clinical trials
Addressing Key Pains of Earlier Generation Outsourcing:
- Delays and Expanding Project Management Costs:
- Problem: Traditional outsourcing models often lead to project delays and escalating project management costs due to inefficiencies and misaligned priorities between the sponsor and service providers.
- Solution: The Cellular Services Model (CSM) introduces specialised, self-contained teams (cells) dedicated to specific tasks, ensuring focused and efficient execution. This structure streamlines processes, reduces delays, and minimises project management overhead by fostering accountability and responsiveness within each cell.
- Poor Deliverable Quality and One-Size-Fits-All Approach:
- Problem: The one-size-fits-all approach of second-generation outsourcing fails to meet the specific objectives of diverse clinical trials, often resulting in poor quality deliverables that do not align with the trial’s unique requirements.
- Solution: CSM’s specialised teams tailor their efforts to the precise needs of each clinical trial. This customisation enhances deliverable quality by leveraging deep expertise and focused attention, ensuring that the outputs are aligned with the trial’s objectives and regulatory standards.
- Lack of Communication and Accountability Across Partners:
- Problem: Second-generation outsourcing suffers from fragmented communication and a lack of accountability among different service providers, leading to mis-coordination and inefficiencies.
- Solution: CSM promotes enhanced communication and collaboration through integrated tools and regular coordination meetings. Each cell operates with clear accountability, ensuring that responsibilities are well-defined and that performance can be closely monitored and managed.
- Power Struggle Between Clients and Service Providers:
- Problem: The growing size and financial power of CROs and service providers compared to their pharmaceutical sponsors create power imbalances, often leading to a race to the bottom on cost and compromising trial outcomes.
- Solution: CSM mitigates these power struggles by fostering a collaborative partnership model. Smaller, specialised cells are more agile and responsive to the sponsor’s needs, enabling a more balanced and cooperative relationship. This model focuses on value over cost-cutting, driving better outcomes and sustainable growth for all parties involved.
By addressing these critical pains, the Cellular Services Model offers a strategic and efficient alternative to second-generation outsourcing, enhancing the quality, accountability, and overall success of clinical trials.
Why organisations are stuck in previous outsourcing strategies?:
- Complexity and Risk: Moving to the third generation involves greater complexity and risk, requiring significant changes in organisational processes and culture.
- Investment: The transition requires investment in new technologies and training, which can be a barrier for some organisations.
- Change Management: Resistance to change within organisations can hinder the adoption of more advanced, strategic outsourcing models.
- Lack of Expertise: Organisations may lack the expertise needed to manage and implement the more sophisticated third-generation outsourcing strategies effectively.
In order to deliver the required benefits of 3rd generation outsourcing it is important to mitigate the above challenges of adopting new strategies. A road map for delivering this is comprehensive and requires the correct partners.
Conclusion and Why Mayet?
The evolution of outsourcing in clinical trials has been marked by significant shifts in focus and strategy, moving from cost reduction to efficiency and quality improvement, and now towards strategic transformation with the Cellular Services Model (CSM).
As the industry faces increasing pressures from regulatory demands, technological advancements, and the need for more efficient and effective trial management, the adoption of CSM presents a crucial opportunity for sponsors to innovate and stay competitive.
By addressing the key pains of second-generation outsourcing, next-generation outsourcing or CSM drives better outcomes and sustainable growth in clinical trials.
As we move forward, embracing these advanced models and tools will be essential for meeting the evolving demands of clinical research and achieving success in this dynamic field.
Mayet’s Value to Next Generation Outsourcing
Mayet is designed to form a critical part of this roadmap as the linking technology partner driving efficiency, quality, risk and compliance in clinical trial outsourcing.
Key Benefits of Mayet for Clinical Trials
- Improved Efficiency: Centralises vendor-related activities, streamlines processes, and saves time.
- Cost Savings: Identifies inefficiencies and areas for improvement, helping reduce costs.
- Enhanced Compliance: Ensures adherence to regulatory requirements, minimising risk.
- Data-Driven Decision Making: Provides comprehensive data and insights, enabling informed decisions.
- Better Communication: Facilitates stronger communication and collaboration with internally and externally vendors.
- Stress Reduction: Offers better visibility and control, reducing organisation pain points associated with managing multiple vendors.
Why Mayet is Essential for Adopting CSM
- Integration Capabilities: Integrates with existing clinical trial management systems, ensuring a seamless transition.
- User-Friendly Interface: Provides an intuitive, user-friendly interface that enhances user experience and productivity.
- Security and Compliance: Implements robust security measures to protect sensitive clinical trial data and ensure regulatory compliance.
