You’ve just discovered a new generation of technology for diagnosing medical conditions, providing better patient outcomes, or even saving lives. But from today’s status to commercializing your product is a long way. Your immediate future includes finding investors, creating a sales package and regulatory pitch, gathering testimonials, achieving milestones, gaining regulatory approval, fine-tuning your stories, creating supplemental material, conducting clinical trials, and countless details on your journey to bring your innovative idea from concept to market and beyond; and it’s disheartening. This is where CROs come in.
What is CRO?
A contract research organization (CRO) leads the birth of new healthcare product ideas and their subsequent spin-off companies through regulatory and clinical pathways to market.
A CRO can benefit your organization with a range of expertise under one roof. A CRO should not only bring you the experience, but also the efficiency of working with the myriad of experts needed to get you 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 typically 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 approvals to seek for the fastest and most efficient way to market
- Communication with regulatory authorities such as the US Food & Drug Administration and other regulatory agencies around the world
- Achieving, tracking and analyzing milestones
- Achieving regulatory requirements
- Setting up and managing clinical trials
- Recruiting an effective board
- Access to contract sourcing expertise, resources and tools for quick go-to-market
- Gain insight and expertise into the hidden aspects of the clinical trial and approval process.
Role of CROs
Contract research organizations can play a significant role at almost every stage of the process of bringing a drug or device to market. This is why more and more pharma and biotech innovators are hiring CROs to successfully manage the process.
CROs can help innovators reduce time-to-market delays, which is key to gaining an edge over the competition. And despite the upfront costs, CROs can ultimately help companies save money by streamlining processes, reducing repetition, and providing insight and expertise on the myriad ways to cut costs and avoid costly mistakes.
Finding the right CRO for your needs is a key element in your journey to success. Consider these five questions when choosing the right CRO for your needs.
Beyond the obvious: Five questions to ask when choosing a CRO
Experience in the areas of your specific needs is a given. Consider these next five questions when choosing which CRO will best serve you.
Which large companies does the CRO most often work with?
Many contract research organizations 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, less focused on individual innovators and their unique needs and more focused on common systems and processes. There is nothing wrong with that. But if you’re a team of three to five people and you’re overwhelmed with calls to a lot of people, you should consider gear.
They are used to working with larger orders, larger budgets, extended deadlines and can rely on brand recognition. Their experiences can also sometimes be misleading. Having experience getting multiple products approved can be great, but don’t get too comfortable with the numbers they cite in marketing materials. CROs are usually the product of mergers and pool these numbers. Attrition can also be an issue as the people who worked on these projects may have moved on.
Institutional knowledge is hard to maintain.
Traditionally, they are less likely to be able to tailor their services to the client’s needs.
They are less likely to operate nimbly to meet the rapid and ever-changing needs that smaller, growing companies require to meet their milestones and regulatory requirements to get to market quickly and cost-effectively.
Also read:- What Is Gastroenterology Clinical Trials?
Conversely, CROs that focus their solutions on startups, emerging companies, and smaller or solo innovators are more likely to accommodate the flexible needs and smaller resources of smaller people. Built with agility, they focus their work on creating personal relationships, tailored partnerships and collaborations to lead innovators on their journey to market.
Is CRO a good culture for my needs?
Deeply understanding and articulating the need, market and solution for your product is an essential part of the CRO role. Find out if they have:
- Do you have experience working with clients similar to you and your needs?
- Have you overcome challenges and obstacles in your target market in the past?
- A proven track record of bringing new drugs and devices to market?
- Overused descriptive words such as ‘deep learning’ or processes that are unparalleled.”
- If they use these terms, ask what they mean. If they say the marketing team wrote it, ask what’s behind it.
- Be curious and clarify rather than assume.
- Can they handle your full range of regulatory and clinical services?
Some contract research organizations focus only on specific phases of the regulatory and clinical processes. For example, they can help you set up and manage your clinical trials, but they won’t necessarily help you raise or help you with funding. Or they may be able to provide information on how to gain market access, but lack extensive experience communicating with the FDA or understanding which approvals to seek for the fastest route to market.
The need of CROs
To bring your drug or device to market as quickly and efficiently as possible, you want a CRO that offers comprehensive services to guide you through every stage of your regulatory and clinical journey, including:
Early stage advice. A CRO should be able to guide you through each stage of the process with the intention of avoiding costly delays, incorrect approvals and errors.
Regulatory consultation and communication with the FDA. A CRO should be able to guide you through each stage of the regulatory consultation process, including preparing for success at each meeting and liaising with regulatory agencies such as the FDA.
Payment and market access. The contract research organization should be able to consult on reimbursement and market access to ensure that all potential patients who could benefit from your innovation can access your product at the right price.
Access to financing. If your product stalls for funding, you could lose valuable time to market, which could cost your entire company, not just market share. Accessing the right funding at the right stages can make or break your success.
Bottom Line? You want a CRO partner who will guide you through every stage of the journey and provide you with specialized expertise, case management and industry insight.
How will working with a CRO accelerate my progress?
You should expect to make progress with each meeting, week by week. CRO should grow with your project and you should always know where you are, why you are at this stage and what pieces you need to move forward.
Take a close look at CRO results. Carefully detailed questions can give you critical insight into whether this CRO will save you time and money in the long run.
Also read:- Ophthalmology Clinical Trials Step by Step Guide
Ideally, CRO services should make you money. It’s about more than avoiding headaches, confusion, delays, rework and cost reduction. It is their expertise in reducing liability; to make the process run more smoothly; in positioning your product and your company for success from the start, rather than a clumsy and expensive stumble.
What to expect?
A contract research organization should guide your preparation for regulatory meetings, presentations, and supporting documents so that you are successful at each meeting and understand the modifications and requirements to proceed to market.
This requires a comprehensive understanding of what the regulatory team says they are looking for and knowing the pitfalls that emerging companies often fall into that drain their finances, hope and motivation to continue. Writing for a regulatory body is a very different topic than persuading a thesis advisor, department head, or investors. Many times a full rewrite is done before the regulatory process begins. This can take 20-40 hours or more with guided expertise; imagine how long it could take without it.
Be careful not to overestimate the consulting experience of an individual or organization. What I mean by this is that often groups tout their “relationship” with the FDA or have consultants who have worked at the FDA in the past. I have come across many people in the industry who trade their “FDA time” but have never worked on more than a few projects. Or they name people they know or are friends with. This may be more of a red flag than a distinguishing feature.
Many people exaggerate their experience and influence to win your business. To protect your business from this, ask questions and place value where it will serve you best. How can they move your project forward? The CRO should guide you with documentation, applications, planning and managing regulatory and clinical meetings, and securing funding to take you from concept to market and beyond.
Contact Vial for CROs service across the United States.