Bringing a drug or medical device to market requires more than intensive R&D. It demands expertise in clinical trials, FDA regulations, funding strategies, and much more.

Drug and device innovators should be focused on innovation, not administrative burdens. To succeed, they need partners who provide not just services but strategic guidance throughout the process that complements their team’s workflow. That’s why more and more innovators in this space are examining how they can better work with CROs to help them successfully navigate the process of launching a drug or device. 

What is a CRO?

A CRO, or a Contract Research Organization, is a company that partners with businesses in the pharmaceutical, biotech, and medical device industries to help them bring their product to market through:

• Contracted research services (e.g., drug discovery, preclinical testing, bio-analysis),
• Liaising with national agencies and committees,  
• Clinical trial management and conduct, and  
• Additional support throughout the regulatory and clinical development process.

The bottom line? CROs play a significant role in just about every phase of the process of bringing a device or drug to market. 

Notably, CROs can help innovators reduce delays in product launch–key for gaining an edge over competitors. Despite the upfront cost, they can ultimately help companies save money by streamlining processes, reducing repetition, and providing insight and expertise into how to limit costs and avoid expensive mistakes. 

Still, partnering with a CRO isn’t necessarily a sure bet. To get the most out of working with a CRO and get your product or device to market as quickly and efficiently as possible, you’ll want to ask specific questions before committing to a partner. 

5 Critical Questions to Ask Before Partnering with a CRO

Before selecting a contract research organization to support your product getting to market, you’ll want to consider a few factors that can shape the outcome of both your partnership and your launch success.

Here are 5 questions to consider before committing. 

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1. Do they complement the culture and established workflow within your clinical operations team?

As you plan your project, it’s helpful to map key factors that align with the needs of the project scope and your internal team supporting the project.

Below are some helpful ways you can balance experience and culture fit when you interact with CROs:

• Understand the structure of the project and executive team and identify how they align with and will support your team throughout the project lifecycle   
• Try to learn how each prospective CRO you meet with handles site engagement and selection. Some CROs have clinics internally, established partnerships with networks, or deep relationships with investigators.  

CROs that work with smaller startups and innovators are more likely to focus on personal, customized partnership.

In other words, they’re dedicated to collaborative, hands-on support tailored to the unique needs of each protocol. 

2. Do they have experience relevant to your product and company size?

When evaluating a CRO, ask questions about their experience with your specific therapeutic modality or indication. More importantly, understand how that experience can be enriched by prior experiences from members of your potential project team. Beyond clinical expertise, the CRO’s client demographic and how they tailor strategies for companies of various sizes.  

Asking about a CRO’s experience can help you make an informed decision about partnering with a contract research organization that can best meet study specific needs and guide you on the regulatory and clinical roadmap. 

3. Can they support you through the entire product lifecycle?

Some contract research organizations only handle specific phases of regulatory and clinical processes. For example, they may be able to help you with managing clinical trials, but they won’t necessarily be able to partner with you in raising funding. Or they may be able to give insight into how to gain market access, but they don’t have extensive experience with communicating with the FDA. 

To help you get your drug or device to market as quickly and efficiently as possible, your CRO should be able to handle every phase across the regulatory and clinical roadmap, including:

‍Regulatory Affairs

A CRO should be able to help you through every phase of the regulatory consulting process, including liaising with the FDA for various submissions and early engagement meetings

‍Early and Late Phase Clinical Trial Support

A CRO should be able to support the variety of study types you may need to conduct (e.g., first in human, pivotal) to help build clinical evidence for your innovation  ‍

Reimbursement and market access

A CRO should have infrastructure to consult on reimbursement and market access, ensuring that all potential patients who could benefit from your innovation are able to gain access to your product at the right price.

The bottom line? A partner that brings stability and efficiency to every step of the process can be instrumental in successfully navigating key inflection points in the development lifecycle. Ultimately, this identifies risk early on and allows project teams to become integrated with your existing workflows.  

4. Can they help you avoid delays and reduce overall costs?

Taking a close look at the track record of a CRO and asking careful, detailed questions can also give you critical insight into this important question: Will they save you cash in the long run? 

Ideally, the cost of a CRO should be more than offset by what they help you to avoid in terms of delays and costs. But a CRO that can’t deliver on their promises or neglects to give careful attention may increase risk and long-term costs.  

Enrollment often becomes a topic early on that can impact timelines, and with that, the budget.

As you go through the selection process, you should ask to see different scenarios regarding the enrollment period which can provide additional data for the prospective study costs.

The CROs can also use this to tailor an enrollment strategy early on that can balance a specific enrollment period in conjunction with a set target for the number of sites.  

5. Do they have proven experience liaising with the FDA?

One of the greatest benefits of working with a contract research organization is that they can help you navigate the complex and sometimes overwhelming journey of communicating with the FDA for regulatory approval. 

That being the case, make sure to ask plenty of questions about a CRO’s ability to liaise with the Food & Drug Administration. They should be able to help you not only with documentation and applications but with planning and managing various meetings with the FDA.

Look for CROs that have supported pre-IND meetings, IND submissions, and FDA Q&A sessions.

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Partner with Proxima CRO

Proxima CRO is dedicated to personal partnerships with innovators in the pharmaceutical, medical device, and biotech fields. We’re committed to supporting innovators at every stage of the development lifecycle to help them get their drug or device to market faster.

This includes: 

• Regulatory Affairs and Quality Assurance consulting for long-term compliance and audit readiness
• Management and planning for all phases of clinical development  
• Regulatory strategy to help you successfully gain approval and position your product for launch  
• Liaising with the FDA to help you plan and run your meetings successfully

To explore how Proxima CRO can support your product’s path to market, click here to schedule a consultation.