Your choice of a Contract Research Organization (CRO) can mean the difference between your clinical trial running smoothly and it coming across obstacles at virtually every step of the way.
Offering assistance through all phases of clinical trials, CROs can help you save time, effort, and resources while ensuring your trials can go on uninterrupted.
However, to truly benefit from partnering with such outsourced services, you must be highly selective when choosing a CRO. This organization will be an extension of your in-house team, meaning that it will have an immense impact on everything from your data quality to overall trial efficiency.
Below, we’ll take a closer look at how to choose a CRO, which criteria to consider during your selection, and how to streamline the process for the best results.
A Closer Look at CRO and Its Importance
A CRO isn’t a company that takes charge of a few meaningless tasks. It’s an organization that takes on countless vital processes that will determine the success of your clinical trials. Some of its core roles include:
- Sponsor Support: CROs can assist with varied processes, from protocol development to trial design, statistical planning, and more;
- Trial Execution: CROs can take on all trial execution processes, managing patients, data, and all included on-site activities with ease and efficacy;
- Site Management: Tasks such as site selection and monitoring, material and equipment setup, and continual on-site support are common roles that CROs take on;
- Regulatory Support: Taking care of regulatory planning, authoring and compiling required documentation, and ensuring compliance with regional and international laws are just some of the ways in which CROs offer regulatory support;
- Data Management: With a reliable organization, you can outsource all data management needs and have your CRO take care of the entire database design, statistical analysis planning, and data capture;
- Safety and Pharmacovigilance: Have safety testing, data reviews, risk assessments, and other essential safety and pharmacovigilance monitoring conducted by experienced professionals.
However, the exact services provided might differ based on whether you’re partnering with full-service or niche CROs.
A full-service organization will typically provide end-to-end support. It will offer a broad range of services, though they may be more expensive, generalized, and difficult to tailor to your specific needs.
A niche CRO, on the other hand, will typically specialize in areas and might offer support only during specific phases of clinical trials. Although this may mean you won’t get comprehensive support every step of the way, it will give you access to a more tailored, expert approach.
When Is It Time to Outsource to a CRO?
Although partnering with a CRO certainly comes with an abundance of benefits, it isn’t always needed. Whether it’s in your best interest to outsource to a CRO will depend on a few key factors.
Team Size
Smaller teams rarely have enough personnel and resources to carry out a clinical trial from start to finish without additional help.
When your teams are spread too thin, with each member having to wear multiple hats and not having enough time to prioritize their core roles, it’s a clear sign that outsourcing to a CRO could be your best course of action.
Expertise Gaps
Regardless of the size of your team, if you don’t have the right talent onboard, you’re likely to need the help of a CRO. Reliable organizations will provide you with access to experts across fields, whether your teams need additional help with their data management, biostatistics, meeting regulatory requirements, or anything in between.
Geographic Limitations
Conducting clinical trials in different regions comes with unique sets of challenges. Locations such as the EU and Latin America, for instance, will have significant differences in their available infrastructures, patient recruitment practices, and regulations.
Therefore, if you are expanding and are unfamiliar with new geographic regions, and don’t have the time and resources to familiarize yourself with them, you’ll benefit from outsourcing to a CRO.
Budget Constraints
If you were attempting to conduct the entirety of the clinical trial alone, you’d need to hire dedicated in-house teams, invest in data management systems, and develop the necessary infrastructure that would help you lead the trial to completion.
Such internal overhead is often significantly higher than simply outsourcing to a CRO. Most Contract Research Organizations will have fair, transparent, and predictable pricing, allowing you to better manage your budget and limit your expenses.
Trial Phase
Sometimes, whether outsourcing to a CRO is the best step will depend on the trial phase you’re in. Most sponsors choose a CRO for their second and third phases of clinical trials, and when trialing medical devices.
During the early phases and the final phase, the studies are still small and easily manageable with lower overhead.
However, the other stages are more involved, requiring well-established infrastructures, a thorough understanding of all the relevant laws and regulations, and handling a larger patient base, so CRO assistance is often essential.
How to Select a CRO: 10 Criteria to Consider
If you’ve decided to partner with a CRO, it’s time to start looking for the best organization to outsource to. However, you’ll need to be highly selective and ensure you make the right choice right from the start. The only question is how to select a CRO that you know you can rely on.
Fortunately, that’s easier than it may appear. You simply need to know which questions to ask and which criteria to consider.
- Therapeutic Area Experience
Be it rare diseases, oncology, infectious diseases, dermatology, or anything in between, you’ll want to ensure that the CRO you choose has adequate experience in the specific field you’re interested in.
Experienced CROs have a better understanding of the relevant safety protocols, patient selection processes, and unique risks that come with the therapeutic area. They’ll know precisely what they can expect, so your trials can be completed faster and with fewer hurdles.
- Regulatory & Quality Track Record
One of the most common reasons why sponsors outsource to CROs is that they need assistance with regulatory compliance. If that’s also one of your main reasons, you’ll want your chosen organization to be fully familiar with all the relevant guidelines, from FDA to ICH-GCP, EMA, GCP, and everything in between.
It would be a good idea to look into your chosen CRO’s inspection history, as well as their QA systems, to ensure everything is done by the book.
- Trial Size & Phase Expertise
Considering that the need for outsourcing tends to be the highest during phases two and three, you should have no difficulties finding a CRO that specializes in them, in particular. If you need assistance with earlier phases or post-marketing studies, you might need to look into more niche organizations.
Additionally, it’s important to look into the average trial size that your chosen CRO commonly deals with. If you’re planning a large-scale study and are working with a CRO that commonly handles lower patient volumes (and vice versa), you’d be more at risk of encountering delays and obstacles.
- Global Footprint or Local Expertise
One of the most crucial factors to consider when choosing a CRO is whether they support and have experience running trials in the country where you want to organize your trial. As mentioned, different locations have vastly different rules, regulations, and processes, and you’ll need your chosen CRO to be well-versed in them.
- Technology & Data Systems
Reliable CROs will always use well-established clinical trial platforms and remote monitoring tools. They’ll use reputable EDC (Electronic Data Capture) and CTMS (Clinical Trial Management System) solutions and adhere to the strictest data security standards.
Perhaps most importantly, they’ll have all the systems in place to give you real-time access to relevant KPIs and reports.
- Project Team & Staffing Consistency
Team and staffing consistency can offer a valuable glance into how the CRO operates. First and foremost, you’ll want to look for CROs that have low turnover rates, meaning your team’s consistency will remain stable during your trial.
You’ll also want to assess their communication style and ensure that the teams you work with remain transparent and responsive at all times.
- Flexibility & Scalability
With clinical trials, you can never know precisely what to expect. You might need to scale up or down quickly or change established protocols. You might encounter unexpected delays or face obstacles you weren’t expecting.
That’s why it’s crucial to work with a CRO that can offer the utmost flexibility and scalability, so you can assess how adaptable your chosen organization is.
- Budget Transparency
Organizing clinical trials doesn’t come cheap, and neither does hiring a CRO. That said, you’ll still want to know precisely what you can expect. Make sure that there are no hidden costs that could create unpleasant surprises down the line and that the pricing is fair and transparent at all times.
Additionally, look into your CRO’s change order frequency and whether it suits your needs.
- References & Case Studies
It’s best to have a close look at any references and case studies a CRO can provide. They’ll give you deeper insights into how the organization works, what value it can offer, and precisely how it can assist you during your clinical trials.
The more references and case studies the CRO can provide that are relevant to your chosen therapeutic area, the better.
- Cultural Fit
The final item on your clinical trial outsourcing checklist would be the cultural fit. You’ll want everything from the overall collaboration style to values, and work ethics to align.
That will ensure that the communication between you and your chosen CRO is always clear and transparent, so that you can both establish realistic expectations.
Warning Signs to Keep in Mind
The aforementioned are the things to look for in a CRO. However, there are also a few warning signs you should keep in mind that would indicate you’ll want to look for different partners:
- High Turnover: With inconsistent staff, you could encounter issues with trial delays, poor communication, and a lack of transparency;
- Slow Responsiveness: Slow responsiveness indicates that you will encounter communication issues throughout your trial, which could impact your timelines, budget, and ultimately your success;
- Vague Budgets: Vague budgets often come with hidden costs that could significantly set you back;
- Lack of Documentation: Inability to provide references and case studies, regulatory and quality track record, and more could mean that the CRO is trying to hide its prior issues that could impact the quality of your clinical trial.
Keep these red flags in mind when selecting a CRO, and make sure to avoid any organization that has them.
CRO Selection Process
Although it may seem overwhelming, you can easily streamline the entire CRO selection process into four key steps:
- Request for Information (RFI)
Collect essential information to prequalify relevant CROs, assessing their therapeutic areas, the clinical trial phases they specialize in, the regions they cover, and all their certifications and quality systems.
- Request for Proposal (RFP)
Detail your clinical trial needs and discuss protocols, expected timelines, services needed, your budget, and expected deliverables.
- Bid Defense
Schedule a meeting to address any questions and concerns you may have, familiarize yourself with key personnel, assess the CRO’s cultural fit, and align your expectations.
- Contracting
Finally, go over all the legal and financial requirements, negotiate your contract, and formalize your partnership.
Finding a suitable CRO can be a time-consuming process, but the more effort you put into finding just the right partner, the smoother you can expect your trials to go.
Choosing a CRO Doesn’t Have to Be Challenging
Your choice of a CRO will impact everything from your budget to your timeline and trial success. Partnering with the wrong organization can only result in delays and potential regulatory issues that could render your trial invalid.
Therefore, scrutinizing every available CRO, carefully assessing whether they meet your essential criteria, and looking out for warning signs should be your top priorities. To avoid costly mistakes, contact TMClinical and enjoy comprehensive CRO oversight and vendor management services that ensure you can find the right partner for your clinical trial.