Introduction
Contract Research Organisation (CRO) outsourcing has become a vital strategy for pharmaceutical and biotechnology companies aiming to optimise clinical research and drug development. Through partnerships with CROs, sponsors can access specialised expertise, reduce operational costs, and accelerate the time-to-market for new treatments. Understanding the various outsourcing models, their benefits, and the latest industry trends is essential for making informed decisions in CRO partnerships.
What is CRO Outsourcing?
CRO outsourcing involves delegating clinical research activities to third-party specialists in trial management, regulatory compliance, data analysis, and other vital functions. These partnerships allow sponsors to focus on their core competencies while drawing on the CRO’s established infrastructure and expertise. By outsourcing to a CRO, companies can efficiently manage resources and maintain regulatory compliance.
Types of CRO Outsourcing
When it comes to outsourcing, there are a few different ways sponsors can structure their partnerships with CROs. The right model often depends on the specific needs of the project and the level of support required. Whether you’re looking for targeted expertise, end-to-end management, or something in between, the following are the main models which offer varying degrees of flexibility and control.
Functional Service Provider (FSP)
In an FSP model, sponsors outsource specific clinical trial functions such as clinical data management, biostatistics, or clinical monitoring. The sponsor is looking to attain the support of a whole group of individuals, which the CRO supplies and manages that functional group. This approach offers flexibility as the sponsor is able to scale up and down the level of resources they need quickly, without the burden of internally scaling their own resources. It also allows sponsors to select specialist CROs for different services and/or conduct more trial operations in-house and only outsource certain services.
Full-Service Outsourcing (FSO)
FSO refers to outsourcing to a CRO for the entire clinical trial project, from planning, regulatory submissions and patient recruitment through to data analysis and final reporting. . This approach is suited for companies seeking comprehensive, end-to-end management with minimal internal oversight.
Hybrid Model
A hybrid model combines elements of both FSP and FSO, enabling sponsors to outsource selected functions while maintaining control over critical aspects of the trial. This offers a balanced strategy, providing both flexibility and robust support.
Task Level Approach
In this model, a sponsor outsources specific processes or tasks. The scope of the work is clearly defined, and a sponsor is gaining support on specific items within their own clinical development process that they may like expertise or resource. They are not looking for a CRO to manage a whole functional team or run a trial from start to finish, but could be looking for unique specific support on individual items such as generation of a statistical analysis plan (SAP), the study design of the trial, the clinical trial reporting or data management collection and database lock. Agreements with CROs in this approach are likely to use a fixed pricing model as opposed to time and materials, which you are more likely to see with functional outsourcing models.
Benefits of CRO Outsourcing
Outsourcing to a CRO isn’t just about saving time or money. Still, it can also bring a range of strategic benefits that help sponsors run more efficient, flexible, and successful clinical trials.
Let’s take a look at some of the key advantages.
Conversion of Fixed to Variable Costs
By outsourcing to a CRO, sponsors can transform fixed costs – such as maintaining in-house teams and infrastructure – into variable costs. They only pay for services when needed, which can greatly enhance financial agility.
Reduction in Employment Costs
Partnering with a CRO can significantly lower employment-related expenses, including salaries, benefits, and taxes. CROs often operate in regions with lower labour costs and streamline processes to reduce overheads, passing these savings on to their clients. Some sponsors are already trying to reduce employment costs but hiring multiple contractors; however, with legalisation such as IR35, more sponsors are having to look at alternative methods to the contractor model, which makes outsourcing to a CRO more appetising.
Faster Time-to-Market
With established trial infrastructures, streamlined regulatory pathways, and extensive patient recruitment networks, CROs can speed up clinical development. Sponsors gain a competitive edge, especially in fast-moving therapeutic areas, by shortening development timelines.
Risk Reduction and Operational Efficiency
Outsourcing to a CRO for trial execution helps reduce risks such as compliance failures, recruitment issues, and regulatory delays. With their specialised knowledge, CROs efficiently navigate these challenges, enabling pharmaceutical and biotech firms to concentrate on innovations while maintaining compliance and operational excellence.
Scalability and Flexibility
By outsourcing to a CRO, you can respond to the demands of your pipeline more efficiently. This is because a CRO can ramp up or reduce the resources needed much faster than a sponsor typically can in-house. There’s no need to maintain a large internal workforce that may be underutilised at times, as the CRO assumes the responsibility and offers greater flexibility based on the sponsor’s needs. CROs are well positioned for this, as they can shift their resources between different sponsor projects as required.
Considerations When Outsourcing Clinical Trials
While the benefits of CRO outsourcing are clear, getting the most out of these partnerships requires careful planning and due diligence. Here are some key factors to keep in mind when deciding to outsource your clinical trials.
Governance, Communication, and Risk Management
Implementing a clear governance and maintaining consistent communication with CRO partners supports smooth collaboration and effective risk management throughout a trial. Appointing a dedicated project manager and establishing escalation pathways can help resolve issues proactively and keep the study on track. CROs often manage multiple projects per project manager, enabling more cost-effective oversight than the typically layered structures within sponsor organisations.
Comprehensive Cost and Overhead Analysis
Sponsors should thoroughly compare internal costs with those proposed by the CRO, including labour, infrastructure, legal services, and facility maintenance, while identifying any potential hidden fees. This ensures that outsourcing decisions are both economically and strategically sound. While benchmarking can be a useful reference, it may not fully account for newer technologies or the unique efficiencies of experienced project managers, potentially skewing cost comparisons.
Recruitment and Resource Utilisation
It is essential to evaluate the CRO’s staffing capabilities and workforce distribution. Ensuring the CRO has the right expertise and flexibility helps avoid delays and resource imbalances. Reviewing CVs and previous project outcomes can help sponsors choose the most suitable project team. Roles like statisticians or medical writers often experience peaks and troughs in workload. CROs help smooth these fluctuations by reallocating resources across projects as needed.
Project Scope, Deliverables, and Assumptions
Clearly defining project deliverables, assumptions, risks, and contingency plans is crucial for all stakeholders. A well-documented scope minimises misunderstandings, aligns expectations, and helps ensure the clinical trial progresses as planned. A clearly written protocol is also key to accurate time and cost estimation, ensuring both sponsor and CRO are aligned on expectations from the outset.
Current Trends and Future Outlook in CRO Outsourcing
As the industry continues to evolve, so too do the expectations placed on CROs. From new technologies to shifting trial models, staying on top of the likes of how clinical trial trends are redefining drug development is essential for sponsors looking to make informed outsourcing decisions.
Technological Advancements
The CRO industry is changing rapidly due to technologies such as artificial intelligence, machine learning, and big data analytics, which optimise trial efficiency, improve patient recruitment, and streamline regulatory processes.
Decentralised Clinical Trials (DCTs)
The rising popularity of decentralised clinical trials allows sponsors to use remote monitoring and telemedicine solutions. This approach is improving patient engagement, expediting data collection, and creating more efficient study outcomes.
Conclusion
CRO outsourcing has become a pivotal strategy for organisations seeking to streamline clinical research and drug development. By carefully selecting an outsourcing model, whether functional, full-service, or hybrid, companies can benefit from cost savings, specialised expertise, and shorter development timelines. Nonetheless, success hinges on robust governance, clear communication, and thorough planning. As technology continues to evolve, staying informed about emerging trends will help sponsors and CROs stay competitive and maintain the highest standards of quality and compliance.
At Quanticate, we specialise in collecting, analyzing and reporting clinical and real-world data across statistical programming, biostatistical consultancy, clinical data management, pharmacovigilance, medical writing and regulatory submission review services. Whatever the data, we’ve got you covered. If you are looking for support on any of the topics highlighted in this blog, please submit an RFI, and a member of our team will be in touch with you shortly.
