Kevin Coker, co-founder and CEO of Proxima Clinical Research provides insight on what is needed to take your medtech, biotech or pharma product from concept to market, quickly.
You’ve just discovered the next generation of technology to diagnose health conditions, provide better patient outcomes, or even save lives. But it’s a long way from where you are today to commercialising your product. Your near future includes finding investors, creating a sales deck and a regulatory pitch, collecting testimonials, achieving milestones, obtaining regulatory approval, refining your stories, building collateral material, conducting clinical trials, and the myriad of details along your journey to bring your innovative idea from concept to market and beyond; and it’s daunting. That’s where CROs come in.
What is a CRO?
A contract research organisation, or CRO, guides the birth of new medical product ideas and their subsequent emerging companies through the regulatory and clinical pathways to market.
A CRO can benefit your organisation with a breadth of experience under one roof. A CRO should not only bring you experience, but also efficiency in working with the myriad of experts needed to get from concept to market. Go out and hire ten consultants to work with your company versus one or two service providers and you’ll see what I mean. Expertise that is usually found only in large companies with deep talent benches should be available to all companies, regardless of size, such as the expertise required in:
- Understanding which approval to seek for the quickest, most efficient way to market
- Communicating with regulatory agencies like the USA Food & Drug Administration and other regulatory agencies around the world
- Reaching, tracking, and analysing milestones
- Achieving regulatory requirements
- Setting up and managing clinical trials
- Recruiting an effective board of directors
- Accessing contract resource expertise, resources, and tools to get to market quickly
- Gaining insight and expertise into the hidden aspects of the clinical trial and approval process.
Contract research organisations can play a significant role in just about every phase of the process when bringing a drug or device to market. That’s why more and more innovators in pharma and biotech are hiring a CRO to successfully navigate the process.
CROs can help innovators reduce delays in product launches, which is key for gaining an edge over competitors. And despite the upfront cost, CROs can ultimately help companies save money by streamlining processes, reducing repetition, and providing insight and expertise into the myriad of ways to limit costs and avoid expensive mistakes.
Finding the right CRO for your needs is a key element of your journey to success. Consider these five questions while selecting the right CRO for your needs.
Beyond the obvious: Five questions to ask while selecting a CRO
Experience in the areas of your specific needs is a given. Consider these additional five questions when selecting which CRO will serve you best.
What size companies does the CRO tend work with most often?
Many contract research organisations work almost exclusively with large pharmaceutical companies. What this says about their approach:
- Their culture is likely to be more formal, corporate, and process-oriented, focussing less on individual innovators and their unique needs, and more on rote systems and processes. Nothing wrong with that. But if you are a three- to five-person team and get overwhelmed on calls with a lot of people on them, you should consider the fitment.
- They are used to working with larger contracts, larger budgets, extended timelines, and can rely on brand name recognition. Their experience can sometimes be misleading, too. Having experience with multiple product approvals can be great, but don’t put too much comfort on the numbers they put in the marketing materials. CROs are usually a product of mergers, and they pool these numbers. Also, attrition can be an issue, as the people that worked on those projects may have moved on. Institutional knowledge is tough to retain.
- They are traditionally less likely to have the ability to flex or tailor their services per the needs of the client.
- They are less likely to operate with agility to meet the quick, ever-changing needs that smaller, emerging companies require to meet their milestones and regulatory requirements get to market quickly and cost efficiently.
On the contrary, CROs that focus their solutions on start-up organisations, emerging companies, and smaller or solo innovators are more likely to meet the flexible needs and lower resources of the smaller guy. They are built with agility and focus their work on creating personal relationships, customised partnerships, and hand-holding collaborations to guide innovators through the journey to market.
Is the CRO a good cultural fit for my needs?
Having a deep understanding and conveying the need, the market, and the solution for your product is a vital part of the role of the CRO. Find out if they have:
- Experience working with clients similar to you and your needs?
- Overcome challenges and hurdles in your target market in the past?
- A proven track record launching new drugs and devices?
- Overused descriptive words such as “deep learning” or unparalleled processes.”
- If they use these terms, ask what that is about. If they say the marketing team wrote it, ask what’s behind it.
- Get curious and clarify rather than assume.
Can they handle your full scope of regulatory and clinical services?
Some contract research organisations focus only on specific phases of regulatory and clinical processes. For example, they may be able to help you set-up and manage your clinical trials, but they won’t necessarily be able to source or help you in fundraising. Or they may be able to provide insight on how to gain market access, but they don’t have extensive experience communicating with the FDA or understanding which approval to seek for the quickest route to market.
To take your drug or device to market as quickly and efficiently as possible, you want a CRO that offers comprehensive services to guide every phase of your regulatory and clinical journey, including:
- Early-stage consulting. A CRO should be able to guide you through each phase of the process, with intent to avoid costly delays, misaligned approvals, and mistakes down the road.
- Regulatory consulting and communicating with the FDA. A CRO should be able to guide you through every phase of the regulatory consulting process, including preparation for success at each meeting and liaising with the regulatory agencies such as the FDA.
- Reimbursement and market access. A contract research organisation should be able to consult on reimbursement and market access, to ensure that all potential patients who could benefit from your innovation can gain access to your product at the right price.
- Access to funding. If your product stalls out due to funding, you could lose valuable time to market which could cost the entirety of your company, not just market share. Access to the right funding in the right phases can make or break your success.
The bottom line? You want a CRO partner who can guide you through every phase of the journey and deliver specialised expertise, case management, and industry insight along the way.
How will working with the CRO accelerate my progress?
You should expect progress with each meeting, week by week. The CRO should be advancing momentum with your project, and you should always know where you are, why you’re at that stage, and the pieces needed next to advance further.
Take a close look at the CRO’s track record. Asking carefully detailed questions can give you critical insight into whether this CRO will save you time and money in the long run.
Ideally, CRO services should make you money. It’s more than the avoidance of headaches, confusion, delays, do-overs, and reduced costs. It’s their expertise in reducing liability; in making the process run more smoothly; in positioning your product and your company for success from the get-go rather than stumbling clumsily and expensively along.
The contract research organisation should guide your regulatory meeting preparations, presentations, and supporting documents so that you hit a homerun in each meeting and understand the adjustments and requirements to continue forward to market. This takes a comprehensive understanding of what the regulatory team says it’s looking for and knowing the traps emerging companies often fall into that drains their finances, hopes, and motivation to keep going. Writing for a regulatory body is a very different pitch than persuading a thesis advisor, department chair, or investors. Many times, an entire rewrite is performed before the regulatory process begins. This may take 20-40 hours or more with guided expertise; imagine how long it could take without it.
How much experience does the CRO have in communicating with regulatory agencies?
Be careful not to overvalue an individual’s or organisation’s consulting experience. What I mean by that is, often groups will tout their “relationship” with the FDA or have consultants that have worked at the FDA in the past. I’ve come across many people in the field that trade on their “time spent at the FDA,” yet they never worked on more than a couple of projects. Or they name drop people they know or are friends with. This might be more of a red flag than a differentiator.
Many people exaggerate their experience and influence to win your business. To protect your business against this, ask questions and place value where it will serve you best. How can they move your project forward? The CRO should be able to guide you with documentation, applications, planning and managing regulatory and clinical meetings, and securing funding to take you from concept all the way to market, and beyond.
