Pros and Cons of Working with a CRO - ProPharma

28 Jul.,2025

 

Pros and Cons of Working with a CRO - ProPharma

Sponsors may transfer any or all of their many tasks and obligations relating to clinical trials to Contract Research Organizations (CROs). This ability to delegate through a Transfer of Regulatory Obligations (TORO) brings with it a range of advantages to the Sponsor. However, because the Sponsor is ultimately responsible, they must be aware of the drawbacks of giving a CRO so much responsibility.

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If you’re considering CRO services, we’ll explain what you need to know including an overview of what they are along with the pros and cons of working with them.

What is a CRO?

A Contract Research Organization (CRO) is a third-party firm that provides clinical research services including drug discovery, commercialization, pharmacovigilance, and post-approval services. Sponsors can hire a full service CRO to fulfill these functions and outsource clinical trials completely. Alternatively, Sponsors can also hire a CRO to provide guidance and assist internal teams. CROs may be hired on a contract, or a project-by-project basis depending on the Sponsor’s needs.

Types of CROs

Most commonly, CROs are segmented by the services they offer. The types of CROs include:

  • Discovery
  • Preclinical
  • Clinical
  • Laboratory Sciences

However, other specific variations may include a rare disease CRO, orphan disease CRO, oncology CRO, and several others.

What Does a CRO Do?

The primary role of a CRO is to plan, coordinate, execute, and supervise processes relating to the development of a clinical trial. CRO services will vary depending on the specialization of the firm, but typical services include:

  • Regulatory Affairs/Sciences
  • Site Selection and Activation
  • Recruitment Support
  • Clinical Monitoring
  • Data Management
  • Trial Logistics
  • Pharmacovigilance
  • Biostatistics
  • Medical Writing
  • Quality Analysis
  • Validation Programming

The Pros of Working With a CRO

The primary reason for outsourcing clinical trials to a CRO is that the Sponsor has limited internal resources. Working with a CRO gives a Sponsor instant access to virtually everything they need to conduct a successful clinical development program.

Here are some of the positive aspects of working with a CRO:

Sponsors can delegate all their duties and functions to a CRO

This is perhaps the most attractive aspect of working with a CRO. The ability to delegate all of a Sponsor’s duties and functions to a CRO means that the Sponsor can operate a drug development program when they otherwise might not be able to. This enables the Sponsor to leverage several other benefits that come with outsourcing clinical trials.

CROs have the necessary resources already in place

Clinical trials are complex exercises in project management, collaboration, and clinical patient care. To effectively conduct trials, Sponsors can rely on CROs because they already have the necessary resources in place. When tasked under a TORO, a CRO can be relied upon to manage all the responsibilities delegated to them, saving the Sponsor a significant amount of time and money.

CROs are prepared to move forward

Time is always of the essence with clinical trials. If a Sponsor needed to create or acquire everything required to run a clinical trial, the project would suffer significant delays. Because a CRO is set up to begin work when called upon, the amount of time it takes to get a trial up and running is reduced exponentially.

CROs have a global reach

In order to develop an application to market a drug in a country, the Sponsor must conduct a study in that country, which can be time and cost prohibitive for a Sponsor. However, a Sponsor can select a CRO that has research facilities and teams located across the globe, providing them with immediate access to the ability to market their drug in multiple countries.

The Cons of Working With a CRO

While working with a CRO has many benefits, there are a range of challenges that Sponsors should always keep in mind. When things go right, the drug proceeds through the trial efficiently. When things go wrong, the Sponsor is exposed to significant regulatory risks because they are ultimately responsible for the quality and integrity of the trial data.

Here are issues to be concerned about when working with a CRO:

Sponsors can delegate all their duties and functions to a CRO

The ability to delegate duties and functions to a CRO is a double-edged sword. While delegation can mean that program tasks get completed, there is no automatic assurance that those tasks will be completed properly. This is an issue because the Sponsor retains ultimate responsibility for the program regardless of the duties and functions delegated to the CRO. If there is a problem with anything related to the CRO’s actions, the Sponsor must deal with the consequences.

It can be difficult to maintain oversight

By the nature of the arrangement, Sponsors are not involved with the day-to-day operations of the CRO. Consequently, a line of communication is not always clear. This fact raises concerns relating to the Sponsor’s ability to maintain oversight of the entire program. And, the larger and more complex the trial, the more difficult it is to maintain oversight. Again, if the CRO mismanages any part of the trial, the ultimate responsibility lies with the Sponsor.

Multiple audits are necessary

Since the CRO must handle so many tasks under a TORO, and because the CRO is ultimately responsible for the CRO’s handling of the trial, the Sponsor must conduct multiple audits to protect their interests. This means conducting a prequalification trial to ensure that the CRO can provide the services that the Sponsor needs with the necessary quality. It also means conducting routine audits at points during the trial to ensure the quality of the program, and conducting an audit near the end of the program to make sure that the program is closed properly. Essentially, audits are less of a con than they are "must-haves."

ProPharma Enhances the CRO Partnership

The success of a Sponsor’s clinical development program depends on their ability to leverage the pros of working with a CRO while managing the cons. With a focus on oversight, ProPharma helps Sponsors navigate this challenge so they can have a positive experience with their CRO while meeting regulatory requirements.

At the start, we can design the qualification process and conduct a prequalification audit. This helps Sponsors select the right CRO for their program. Additionally, ProPharma can design a quality system that addresses compliance in its entirety and is tailored to the Sponsor’s unique needs. To manage the cons of working with a CRO, the quality system is grounded in effective vendor management and oversight processes. To maintain compliance, ProPharma can conduct mock audits.

What is a Full-Service CRO? A Comprehensive Guide - Quanticate

What is a Full-Service CRO?

Clinical research plays a vital role in bringing new medical treatments and devices to patients. To navigate this complex process effectively, many organisations turn to Contract Research Organisations (CROs).

If you want to learn more, please visit our website CRO Services.

Did you know that a significant portion of clinical trials today rely on the support of CROs? Therefore, understanding the differences between full-service and niche CROs (such as data-focused CROs) is essential for sponsors navigating clinical trials, as the right choice can significantly impact trials success. However, what exactly is a full-service CRO, and how does it differ from niche providers? This article explores the concept, the services they provide, and the advantages they offer to sponsors.

What is a CRO?

A Contract Research Organisation (CRO) is a company that supports the pharmaceutical, biotechnology, and medical device industries during clinical research and development. CROs manage the complexities of clinical trials, ensuring compliance with regulations, protecting patient safety, and maintaining data integrity.

CROs vary in scope. Some specialise in specific aspects of clinical research, while others, known as full-service CROs – the focus of this article – offer comprehensive solutions that cover every stage of the clinical trial process. This flexibility allows sponsors to choose the level of support that best aligns with their needs.

What Services are Offered by Full-Service CROs?

Full-service CROs deliver a broad range of services that guide sponsors through every phase of a clinical trial. Their offerings typically include study design, protocol development, regulatory submissions, patient recruitment, site management, clinical trial monitoring, and post-market surveillance.

For instance, a full-service CRO might streamline regulatory submissions using AI-powered tools or optimise patient recruitment through global networks. These organisations also utilise advanced technologies, such as artificial intelligence and real-time data analytics, to improve efficiency and deliver actionable insights. This comprehensive approach is particularly advantageous for large-scale or multinational studies, where smooth coordination and consistency are crucial.

Advantages of Partnering with a Full-Service CRO

Collaborating with a full-service CRO has advantages such as the centralising all support with a single provider. This reduces the project management required when managing multiple vendors. Full-service CROs will have good collaboration between departments which can improve communication and governance with their clients.

Additionally, full-service CROs tend to have the ability to scale their services which makes them suitable for both small studies and large, global projects. Importantly, full-service CROs also offer customisation, which ensures that trial strategies can be tailored to sponsor needs and adjusted as studies evolve. While the initial investment may seem significant, the long-term efficiencies make it a worthwhile choice for many organisations.

Disadvantages of Selecting a Full-Service CRO

One of the key drawbacks of opting for a full-service CRO is the lack of niche focus. These organisations often function as generalists, providing broad-spectrum solutions rather than specialised expertise. As the saying goes, they risk becoming a ‘jack of all trades, master of none.’ While their comprehensive approach covers all aspects of clinical trials, sponsors looking for deep, tailored insights into specific therapeutic areas or trial methodologies may find that full-service CROs fall short in this regard. This can be particularly challenging for studies that require intricate knowledge of rare diseases, innovative trial designs, or complex regulatory pathways.

Another potential downside is that data management and quality assurance can sometimes take a backseat to revenue-generating services such as clinical monitoring. While clinical monitoring is undoubtedly crucial, poor data quality is one of the leading causes of trial failures. If a CRO’s primary focus leans towards operational execution rather than robust data collection and analysis, sponsors may encounter issues with regulatory compliance, delayed approvals, or unreliable study outcomes. Given that high-quality data is the foundation of any successful trial, sponsors should carefully assess a full-service CRO’s commitment to data integrity before engaging in their services.

The Role of Niche Providers in Clinical Research

While full-service CROs offer comprehensive solutions, it’s important to understand the role of niche providers in clinical research. These organisations focus on specialised areas, and their expertise often complements the broader services of full-service CROs. In some cases, full-service CROs may collaborate with niche providers to enhance specialised aspects of their operations.

Niche CROs specialise in particular areas, such as patient recruitment, regulatory compliance, biometrics services like clinical data management and statistical programming, or therapeutic expertise in fields like oncology or rare diseases, for example. Their in-depth knowledge and focus make them an excellent choice for sponsors with targeted requirements. For example, niche CROs often bring unparalleled expertise in generating real-world evidence, ensuring that studies capture meaningful patient outcomes and demonstrate the effectiveness of treatments in diverse, real-life settings, which can be crucial for certain studies.

Additionally, niche CROs tend to offer more personalised attention, as their smaller size allows them to develop closer relationships with sponsors and provide hands-on support. This level of engagement can lead to faster problem-solving and greater flexibility in adapting to unexpected challenges.

Functional Service Providers (FSPs) in Clinical Research

Functional Service Providers (FSPs) offer another approach to clinical trial support, focusing on specific tasks or functions rather than covering the entire trial process. Sponsors might outsource areas like data management, site monitoring, or biometrics to an FSP while retaining overall oversight. This can provide a cost-effective and flexible option for organisations with established internal infrastructures that only require targeted external expertise.

Strategic Considerations for Choosing Between a Full-Service CRO or Data-Focused CRO

When deciding between a full-service CRO and a data-focused CRO, sponsors should first evaluate their internal capabilities. If an organisation has strong in-house expertise in clinical operations but requires robust data management and analytics, a data-focused CRO may be the optimal choice. Conversely, if internal resources are limited or the trial requires extensive coordination across multiple areas, a full-service CRO’s end-to-end approach can streamline operations and enhance overall efficiency.

Budgetary considerations also play a significant role. Full-service CROs often involve higher upfront costs due to their integrated model, which covers all trial aspects under one provider. However, this model can result in cost efficiencies over time by minimising the need for multiple vendor contracts and reducing the risk of data integration issues. In contrast, a data-focused CRO may offer more flexible pricing models and allow sponsors to invest specifically in high-quality data collection and analytics while managing other aspects of the trial independently.

The complexity and scale of the study should also guide this decision. Large, multinational trials often require the broad capabilities of a full-service CRO, ensuring seamless coordination across diverse regions. On the other hand, trials that rely heavily on real-world evidence, advanced biometrics, or require meticulous data validation might benefit more from the expertise of a data-focused CRO. Ensuring high data integrity is crucial, as poor data quality is one of the leading causes of trial failures and regulatory setbacks.

Finally, sponsors should align their CRO selection with their long-term strategic goals. Organisations seeking rapid market entry or planning multiple studies within a specific therapeutic area may benefit from the comprehensive services of a full-service CRO. However, those prioritising data-driven insights, regulatory compliance, and precision in analytics may find greater value in a data-focused CRO. By carefully evaluating these factors, sponsors can select the right partner to support their research objectives and ensure the success of their clinical trials.

Conclusion

A full-service CRO provides a seamless, integrated approach to clinical research, making them an ideal partner for managing complex or large-scale trials. By reducing operational challenges and serving as a single point of accountability, they streamline the clinical trial process and enhance overall efficiency.

Whether you choose a full-service CRO or a niche data-focused provider depends on the specific needs of your organisation. While full-service CROs offer comprehensive solutions, data-focused CROs prioritise high-quality data management and analytics, ensuring robust study outcomes. By understanding the services and benefits of each, you can make an informed decision that supports your clinical research goals.

As the CRO landscape evolves with advancements in technology and trial decentralisation through the use of wearable devices, organisations that adapt to these trends will be best positioned for success. Adding innovative tools and expertise to support these shifts makes full-service CROs an invaluable asset for forward-looking sponsors.

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