Let's start from the beginning: What is a CRO?
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CRO is the acronym that stands for Contract Research Organization. Briefly, CROs provide support to different industries (such as the cosmetic, pharmaceutical, and biotechnological industries) by offering them the outsourcing of part of their research. In other words, contracts are signed between companies and CROs by which the latter engages to conduct and complete specific tasks (e.g., assays, analysis, communication services).
Today, more and more companies rely on CROs not only for different preclinical R&D needs but also for managing clinical trials. Indeed, the broadest classification level for CROs divides them into preclinical and clinical. In this article, we will only focus on preclinical CROs.
The research involved in the development and preclinical testing of new products is often too complex to conduct in-house, especially for smaller companies. This is why many businesses turn to CROs to avoid the additional costs of assembling an in-house research team for every project. So how to know if this option is also suitable for your company?
To answer this fundamental question, you need to precisely assess your company's existing capabilities and contrast them with the requirements of the research project you want to undertake. If you determine that all your project activities can be done in-house or that any gaps can be closed with only a small investment, your project may not need a CRO this time. However, if your project's needs outstrip your own research capabilities, it most surely makes financial sense to engage a CRO. In this way, you can continue to focus on your core expertise while outsourcing some of the activities.
1. Does the CRO have the appropriate facilities and technologies?
This may probably be the most essential aspect to consider since it refers to the initial reason why you looked for support in the first place. Thus, before partnering with a CRO, you want to be sure they have all the necessary material resources to support your project. The facilities and laboratories must be appropriately accredited, all the equipment properly maintained and regularly calibrated, and all infrastructure compliant with relevant research practice guidelines.
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2. What are their experience and expertise?
Half of a successful experiment relies on proper facilities and equipment; the other half depends on adequately trained scientific staff. Indeed, the employees of the selected CRO ' whether PhDs, engineers, or technicians ' must have appropriate educational and professional backgrounds, experience, and training in the fields of interest. To assess this, you can require examples of previous projects on the same (or a similar) topic'usually, the greater the experience, the more efficient in procedures and project management.
Also importantly, it's desirable that the staff is open to discussion and exchange, in particular, that it is capable of accurately qualifying your needs, understanding your goals, orienting you to the most suitable solutions, and even suggesting further studies and new directions for your research.
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3. What quality assurance (QA) procedures are in place?
Any decision about a product's safety or efficacy will be made on the assumption that the research behind the data is solid. Quality assurance is, therefore, also critical to good research practices. Thus, to ensure that high-quality standards are applied, it may be worth asking if any methods or procedures are employed to assure the quality of their work and even consult the results of any external audits by regulatory authorities.
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4. How financially stable is the CRO?
Project delays and cancellations ' which are frequent in the research business ' can impact the cash flow of CROs. Before settling on your choice of partner, you want to be confident that they are strong enough to weather various downturns while continuing to support your project.
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5. Do they have a strong communication and project management culture?
It's very important to have a dedicated point of contact in the CRO and know who is responsible for your project. This is useful in the day-to-day and crucial when dealing with unexpected changes. Even the best-managed projects may need their schedules and budgets revised, and you want to work with a team that can manage change proactively and effectively.
Partnering with a CRO can be a helpful solution to bring value to a project. It's important to remember that preclinical CROs can serve more than just an 'extra pair of hands' for performing specific assays. Instead, they can become true collaborators in your research and be a source of new ideas and innovative solutions.
The questions above will guide you through your choice of a CRO partner to help you meet your goals.
You may have noticed that no questions concerning costs were included in the list, and that's because cost evaluation is a complex subject that needs to be assessed delicately. It's clear that costs must be affordable according to your current budget. Yet, the decision to conduct all your research in-house, even when lacking expertise on certain aspects, can lead to even more significant monetary investments. This can be explained by a lack of familiarity with a particular subject, steep learning curves, and unnecessary failures. Thus, in these cases, partnering with a CRO may reduce your costs in the long term.
Clinical trials are not an easy undertaking, considering the exorbitantly high costs associated with running them, as well as the many pitfalls that can hinder their success. A publication by Sun et al. estimated that 90% of drug candidates that reach clinical trials will fail during Phase 1-3 clinical trials and drug approval by the United States (U.S.) Food and Drug Administration (FDA). Similarly, Thomas et al. () found the chances of a new drug reaching the market successfully from conception was only 7.9%, despite the large amounts of time and money commonly invested in clinical trials. These numbers explain why drug development is not a process that can be rushed and underscores the importance of sponsors selecting the right contract research organization (CRO) to ensure their trial's success. However, success depends on far more than just CRO selection.
At its core, the sponsor-CRO dynamic is a partnership and thrives best when there is open, collaborative communication on a continuous basis. It is crucial for sponsors to feel comfortable asking their CRO the right questions because they can help you stay informed, address challenges proactively, and make necessary adjustments to keep your trial on track. In this article, we will highlight ten essential questions that can help sponsors gain valuable insights from their CRO partner, optimize study outcomes, and, ultimately, foster a stronger partnership in which both parties demonstrate their commitment to the clinical trial's success.
Read on to learn how asking your CRO these ten questions can help optimize your ongoing study!
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Reasoning: Approximately 86% of clinical trials experience delays during startup, and for every day of delay, the pharmaceutical industry stands to lose anywhere from US$600,000 to US$8 million. These stark numbers emphasize the importance of asking about the current status of your study relative to the initial timelines, because it can offer critical information that helps minimize financial consequences. Sponsors should also consider that initial timelines are typically based on best-case scenarios, and it is common for unforeseen challenges to come up.
In that case, ask whether your trial's current status stands relative to the original timeline, as well as touch on any delays that may need to be addressed. Problems will be identified in every study, which is the nature of clinical development, but the right CRO will be transparent and able to propose adjustment strategies to overcome unexpected obstacles and help your study stay on track. By asking this question, sponsors and their CROs can work together to identify potential problems, find solutions, and keep their clinical trials moving forward effectively.
Reasoning: The FPI is an important milestone in clinical trials when the first patient is randomized into a study, marking its transition from preparation to active trial enrollment. Meeting an FPI target can help keep study timelines on track more successfully, but the key to success is to ensure that this initial target be realistic. Many sponsors may be swayed by promises of unrealistic timelines from CROs, but this is a common pitfall. In practice, FPI targets can shift drastically depending on the therapeutic area or indication, your trial's protocol or eligibility criteria, the extent of available site support, whether a local or central institutional review board (IRB) was chosen, and many other factors. By evaluating the answer to this question with realistic assessments and relevant data from your CRO, sponsors can avoid future issues and are less likely to enact a contingency plan.
For example, the CRO can provide information about how many sites have been fully activated, whether there are backup sites that can be activated if needed, and what challenges may be contributing to any delays. If FPI takes place more than 30-60 days after the initial target, there may be a delay in enrollment timelines, in which case CROs can enact their contingency plan to ramp up recruitment efforts. The goal for sponsors when asking this question is to maintain an open dialogue with their CRO and identify any areas where sites may need additional support to reach activation and begin enrolling participants.
Reasoning: Question 3 serves several purposes, including measuring your trial's progress against industry standards, determining the CRO's prior experience with similar studies, and whether they can suggest some best practices that have worked before. This is particularly valuable when working with a CRO like TFS that has a long-standing history running clinical trials because they can provide meaningful comparisons. In response to this question, sponsors should inquire about whether their study's site activation or patient enrollment rates are comparable to those of other studies, and if so, what the underlying reasons might be.
What factors may be contributing to your clinical trial outperforming other similar ones in these aspects? Or if it is lagging, what unique challenges is your trial facing that others did not? Asking these insightful questions can invite the CRO to share strategies from their previous successful studies that could be applied to address any persisting challenges. Leveraging important lessons from case studies is crucial for helping streamline future studies because they can help sponsors avoid common pitfalls.
Reasoning: Changes and unexpected circumstances are inevitable with any clinical trial, which means this question is crucial for understanding your CRO's approach in proactively identifying potential problems. Beyond detecting any issues, this question serves to determine what detailed solutions have been planned. This includes setting up robust action plans to address concerns like regulatory hurdles, supply chain issues, delayed patient recruitment, etc., that consider your trial's current status relative to the original plan.
To ensure a strong partnership, concerns such as these, including any supporting data, should be communicated with full transparency and in a timely manner to promote team-based problem-solving. Following this, when solutions are proposed by the CRO, take the time to discuss how well they suit your study's overall goals and timelines. Some approaches may only provide short-term relief, whereas others rely on thoughtful strategies that can be sustained long-term to keep your study on track.
Reasoning: A economic evaluation study analyzed the development costs of clinical trials conducted between and , finding that the mean cost of developing a new drug was approximately U.S.$172.7 million. This value increased nearly five-fold to U.S.$515.8 million when cost of failures was included, suggesting the importance of discussing budget expectations between sponsors and CROs. However, such a topic should be approached in a way that both parties feel comfortable sharing potential changes with each other before coming to an agreement about how best to proceed. For example, based on current study metrics, the CRO may notice more site activation, longer enrollment periods, or increased monitoring visits are needed, all of which require additional resources and costs.
While overextended clinical trials budgets are not ideal, sometimes investing in a seasoned CRO, who can predict future needs based on early indicators, can help clinch your study's success. Responses to this question can help explain the rationale behind new changes in scope and how to keep increased costs and resource use within a reasonable range. Scope changes happen and the goal is not necessarily to avoid them; rather, sponsors should use this question to ensure the changes are justified and communicated early enough to address easily.
Reasoning: Patient recruitment and retention are the two most significant bottlenecks every clinical trial sponsor must overcome with their study, with recruitment often taking up nearly 30% of development timelines and requiring over US$1 billion of spending. The goal of asking this question is to get a comprehensive look into the CRO's current strategies, their adaptability in different scenarios, and a summary of recruitment and retention efforts from previous successful trials. Important quantitative data to consider are the number of patients screened, enrolled, and retained, as well as how these numbers compare to the initial targets.
Beyond that, use this question to determine whether digital technology is being leveraged to boost enrollment. For example, many CROs will take advantage of social media campaigns, patient engagement apps, or third-party digital recruitment specialists. Read this publication here about how digital recruitment can improve trial diversity and inclusion.
The sponsor can also inquire about what recruitment challenges are being observed and whether previously successful strategies can be applied to your study to overcome them. Experienced CROs regularly collect data on recruitment and retention rates, providing a real-time look into which regions might need more targeted efforts, whether back-up sites should be considered and where, and what additional patient support can be provided.
Reasoning: This question is designed to assess the quality of relationships between your CRO and the participating sites, as well as the sites' level of commitment to your study because the success of clinical trials depends on the success of their investigative sites. Sponsors should consider both quantitative and qualitative metrics from their CRO. Quantitative data might include site activation rates, patient enrollment numbers per site, data quality, and protocol adherence. Equally important are qualitative accounts from the CRO about their ground-level experiences with a site, what kind of support mechanisms are in place, and whether challenges expressed by site staff are being proactively managed.
Clinical research sites are the backbone of a clinical trial and both the sponsor and its CRO should strive to understand what factors contribute to standout sites and underperforming sites alike. Recognition announcements, motivational initiatives like authorships on publications, or additional support for underperforming sites can also go a long way in improving engagement. Overall, this question helps ensure your CRO is creating long-term, positive relationships with investigative sites in a way that aligns with your organization's values.
Reasoning: The regulatory landscape of clinical trials is constantly evolving staying ahead of changes is not just a best practice'it is a necessity. It is the responsibility of every stakeholder involved with a clinical study to remain vigilant about these changes, ensuring diligent compliance. With this question, sponsors can ask CROs about their familiarity with the broader industry landscape and how they may plan to adapt to changes accordingly. If the FDA, Health Canada, or the European Medicines Agency (EMA) recently released new guidelines relevant to your clinical trial, the right CRO will have already known and considered how your trial may be impacted. Thoughtful analysis of any changes and their impact would ideally involve a discussion of risks and opportunities in the industry, and what proactive measures are being explored.
For example, is there a new designation pathway that could expedite your drug's approval? Do the changes in regulations necessitate a protocol amendment that is already under development by the CRO? Has a competing drug recently received an approval that may call for certain changes to your study's design or patient population? This question is important for sponsors to ask because it confirms how far forward your CRO is thinking and whether they anticipate future trends that could affect your study.
Reasoning: Aside from the primary bottlenecks that most clinical trials experience, covered earlier with Question 6, it is equally important to ask your CRO more broadly about other potential issues that may not be as apparent. Some specific examples they may provide could include delays in drug supply, recurring issues with data management systems, certain trial activities being associated with more protocol deviations than expected, or obstacles posed by regulatory tasks. As with other bottlenecks, after identifying and communicating these, this question can help the sponsor understand the CRO's strategies to avoid slowing study timelines or extending the budget.
In many cases, contingency plans may involve having backup vendors, system processes, or training materials prepared so any sudden operational or logistical obstacles can be overcome more easily. Of course, we cannot predict every challenge that arises, but using this question to determine whether your CRO is strategically thinking about high-priority bottlenecks can help save your clinical trial a significant amount of time and money.
Reasoning: With this last question, sponsors can gain valuable insights about the practical feedback CROs have received from participating sites and patients. Often, study protocols are designed only to maximize the chances of successful scientific outcomes, but may not directly factor in the patient's experience. Examples of constructive comments from sites could involve insufficient support or issues with the protocol, or conversely, positive patient experiences with the drug or strong support from their assigned clinical research associate (CRA).
However, the most important component of this question is how this feedback is being incorporated to optimize site and patient satisfaction. Concrete ways a CRO can address these comments include allowing reasonable accommodations with study procedures to improve patient centricity, expediting communications for the site in the event they need additional support or equipment, as well as participating in collaborative discussions with site staff about potential solutions when a problem is identified.
In conclusion, asking these 10 key questions to your CRO can significantly improve the chances of your clinical trial being successful. Ultimately, the purpose of these questions is to encourage open communication and transparent teamwork between sponsors and flexible, accommodating CROs . Inquisitively requesting vital information about a study from startup to close-out can help address potential challenges earlier and ensure both you and your CRO are on the same page. This can include aligning expectations with recruitment strategies, site relationships, budget expectations, changes to study timelines, regulatory compliance and more. Regularly engaging by using these questions only strengthens the partnership with your CRO because it promotes a shared commitment to your clinical trial's goals and success.
Is your clinical trial facing unexpected challenges? With deep expertise across multiple therapeutic areas and an adaptive, solution-driven approach, we're uniquely positioned to help you ask'and answer'the 10 essential questions to get your trial moving forward with confidence. From our full-service Clinical Development Services to tailored Strategic Resourcing Solutions (SRS) and Functional Services (FSP), TFS provides the flexibility, insights, and practical experience to meet your study's unique demands.
Choose TFS as your trusted CRO partner and experience how our commitment to proactive collaboration and scientific precision can make all the difference in achieving your clinical goals.
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