Guest post by Youssef Soliman, medical student at Assiut University and biostatistician
In 2025, the outsourcing of clinical trials has become a common strategy for pharmaceutical and biotechnology sponsors. Facing rising R&D costs and complicated studies, sponsors turn to Contract Research Organizations (CROs) and other external partners to manage clinical trials. This practice, known as outsourcing clinical trials, is adopted as a best practice for containing costs and enhancing efficiency in drug development [1]. However, handing off trial responsibilities to outside entities can cause challenges like reduced oversight and quality control that must be carefully managed. In the following sections, we examine the benefits and drawbacks of outsourcing in clinical trials in the upcoming year, explore emerging hybrid outsourcing models, and outline best practices for sponsors. We also highlight how tools like the Clinical Trial Risk Tool can support data-driven decision-making around outsourcing.
For sponsors, outsourcing in clinical trials offers advantages that lead to increased use. A major advantage is obtaining specialized expertise. CROs provide expert knowledge in clinical trial design, regulatory affairs, and data management [2]. They often have experience across various therapeutic areas and established relationships with investigative sites. This provides a global reach that individual sponsors may not have access to. This extent of expertise and framework allows CROs to accelerate trial startup and execution through perfect processes and networks [2].
Cost efficiency is another key driver. Outsourcing to a CRO can be more cost-effective for a sponsor than building and maintaining full in-house capabilities [2]. By using the CRO’s existing staff and facilities, sponsors avoid the expense of hiring permanent personnel or investing in infrastructure for each new trial conducted. Economies of scale often let CROs conduct activities at a lower unit cost. Sponsors essentially pay for services on demand, which can help keep trial budgets under control.
Moreover, partnering with CROs allows companies to focus on other aspects. While the CRO handles operational execution, the sponsor’s internal team can concentrate on drug discovery, product strategy, and other priorities. This ability to focus on core business activities is a frequently cited benefit of outsourcing arrangements [2]. Additionally, outsourcing provides flexibility and scalability. Sponsors can quickly scale trial operations up or down by engaging CRO services as needed, rather than maintaining large permanent teams. This flexibility is helpful for adapting to changing project pipelines or accelerating development timelines when needed.
Despite its advantages, outsourcing trial operations comes with many disadvantages. A major one is the loss of control a sponsor might feel when trial conduct is in the hands of an external entity. Outsourcing can lead to reduced oversight of day-to-day operations, and misalignment in priorities or communication gaps can occur if sponsor and CRO are not in perfect communication [2]. In practice, not all vendors maintain the same standards. If a CRO’s performance is poor, it can risk the study timeline or data integrity [2]. Sponsors must give up a degree of direct control and trust the contractor’s quality and compliance, which can be unsettling.
Communication is another common problem in outsourced trials. Effective communication requires clear, frequent information sharing between the sponsor and service provider. However, working across organizational boundaries (often across different time zones and cultures) can introduce delays or misunderstandings. A lack of transparency or slow updates from the CRO can negatively impact the sponsor’s confidence. Ensuring regular status reports and establishing deliverable acceptance criteria at the start of the trial is crucial to align expectations [3]. Poor communication is known as a factor that can compromise data quality or patient safety if issues are not communicated immediately.
There are also financial and strategic downsides to consider. If not managed well, outsourcing can lead to unexpected costs. For example, protocol changes can require change orders [2]. Services that seemed cost-effective at first may lead to additional fees for extra work, eliminating some of the expected savings. Over-reliance on external partners can also result in dependency risk [2]. A sponsor may lose internal expertise over time, becoming too dependent on CROs for critical functions. If the partnership ends or the CRO underperforms, the sponsor might struggle to regain control of those activities. Finally, the sponsor remains ultimately responsible for trial outcomes in the eyes of regulators. This means that even when using outsourced teams, sponsors must invest effort in oversight, quality assurance, and compliance checks. They cannot fully “set and forget” a trial without courting serious risk.
Outsourcing is not an all-or-nothing proposition. Many organizations today use hybrid models that blend in-house work with outsourced services to get the best of both worlds. For example, a sponsor might keep strategic planning and oversight internal, while outsourcing specific functions, such as data management, biostatistics, or monitoring, to specialized providers. This approach is often called a Functional Service Provider (FSP) model. Another company might outsource an entire study to one full-service CRO for simplicity, whereas a different study could be fully outsourced to multiple providers to acquire unique expertise in each area [4].
Industry research suggests that each outsourcing model has its own pros and cons. Blending internal and outsourced resources can offer increased flexibility and access to skills not available in-house [4]. However, using multiple specialty vendors requires strong coordination. Surveys indicate this approach often comes with integration challenges and higher onboarding effort, necessitating careful oversight by the sponsor [4]. On the other hand, relying on a single CRO can make communication efficient but can leave the sponsor with less direct control, and more than half of sponsors in one survey reported feeling a lack of control with a fully outsourced single-provider model [4]. These hybrid and tailored approaches illustrate that outsourcing in clinical trials is not one-size-fits-all. Sponsors should evaluate their specific project needs, internal capabilities, and risk tolerance to decide which activities to outsource and which to keep in-house.
To maximize the benefits and mitigate the risks of outsourcing of clinical trials, sponsors should follow several best practices.
First, perform thorough due diligence when selecting any outsourcing partner. Evaluate potential CROs or vendors based on their track record, therapeutic area experience, regulatory compliance history, and technical capabilities. Choosing a partner whose strengths align with the trial’s requirements (for example, experience in the relevant indication or study phase) is fundamental to success. A careful vetting and selection process reduces the chance of problems down the road.
Second, establish clear agreements and communication plans up front. A detailed contract should define the scope of work, responsibilities, performance metrics, timelines, and data ownership. It’s wise to include provisions for how changes will be managed and to set acceptance criteria for key deliverables from the outset [3]. This ensures both parties have a mutual understanding of expectations. Additionally, sponsors should maintain robust oversight of the trial’s progress even after delegation. Regular check-in meetings, progress reports, and joint governance committees can help keep the sponsor informed and engaged. Fostering a collaborative relationship (versus a purely transactional one) with the CRO promotes transparency. When the sponsor and CRO work as partners with shared goals, it becomes easier to communicate risks or delays early and address them together.
Third, prioritize ongoing risk management and use of supporting tools. Effective risk management is a cornerstone of successful outsourcing. Sponsors should continuously monitor key risk indicators, such as enrollment rates, site performance, and data quality, rather than assuming the vendor will handle everything. Modern technology can greatly aid in this process. For instance, the Clinical Trial Risk Tool can analyze trial protocols and past data to flag risk factors and estimate trial costs, helping sponsors make informed decisions about which aspects to outsource and how to allocate resources. By using such data-driven tools and adhering to appropriate project management practices, sponsors can gain early warning of potential problems and adjust course before small issues become major crises [4].
In today’s fast-paced research environment, clinical trials outsourcing offers a valuable strategy for sponsors to tap into external expertise, improve efficiency, and potentially accelerate development timelines. At the same time, it is clear that outsourcing is not a easy solution. It carries challenges that demand vigilant management. The decision of whether, and how much, to outsource must be tailored to each sponsor’s situation, considering factors like internal resources, trial complexity, and regulatory obligations. By carefully weighing the pros and cons of outsourcing clinical trials, organizations can craft an approach that captures the benefits while controlling the risks. Ultimately, when managed well, an outsourcing strategy can help bring new therapies to patients faster and more cost-effectively, without compromising data quality or patient safety. Success lies in selecting the right partners, establishing clear processes, and maintaining active oversight. With prudent planning and the support of innovative tools like the Clinical Trial Risk Tool, sponsors can confidently navigate the outsourcing landscape to enhance their clinical trial outcomes.
Creating clinical trial budgets from protocols Creating a clinical trial budget is a fiddly and time consuming process. The playbook for running the clinical trial is a document called the protocol. You can find examples of protocols here. The protocol states how many participants will take part in the trial and also what visits and procedures will take place. Above: a protocol. Source: NCT04128579 A clinical trial manager must read the protocol and look for all pieces of information in the protocol that is relevant to the budget, in particular the Schedule of Events (also called Schedule of Assessments or Schedule of Activities), which is a table or series of tables which indicate which procedures and assessments will take place on which the visits.
We have improved the Clinical Trial Risk Tool in the last 6 months, making it more user friendly and taking on board the feedback that we’ve received. We’ve improved the accuracy of the machine learning components too. The tool now outputs its key figures such as risk levels and estimated cost in easily readable cards, so you can see at a glance the key takeaways from your protocol: The risk factors are now organised into collapsible categories, so you can explore them easily without an information overload.
Guest post by Safeer Khan, Lecturer at Department of Pharmaceutical Sciences, Government College University, Lahore, Pakistan Introduction The success of a clinical trial is strongly dependent on the structure and coordination of the teams managing it. Given the high stakes and significant impact of every decision made during the trial, it is essential for each team member to collaborate efficiently in order to meet strict deadlines, comply with regulations, and ensure reliable results.
