Congratulations, you've done it. Your early-stage life science company is up and running! But now what? You have money in the bank (well, a little), your technology is revolutionary, and your C-Suite is full of experts in the field. But you want to start with the end in mind. You want to make sure that you've crossed all the T's and dotted all the I's. There is one step your company is missing, but you can't quite put your finger on it. Then it hits you! The only pathway to commercialization is through the hurdles of clinical trials and FDA regulations. You've considered hiring a Contract Research Organization, but it was farther down on your timeline. Should you consider getting one from the very beginning? Below are just a few of the many reasons that a Contract Research Organization (CRO) can be most effective when used from concept to commercialization:
1) Streamlining Development
Having a CRO from the beginning, or proof of concept stage, provides you a one-stop-shop for all resources you need and questions you will have. Being with a single CRO throughout your development process leaves little room for miscommunication when it comes to timelines and pricing. When your CRO familiarizes itself with your technology from the start, it eliminates any additional start-up costs of learning about your company and device along the way. The CRO will have an understanding of the specific nuances of your unique device, not only comparable devices in similar indications. Having this knowledge will allow the CRO to anticipate any device-specific issues during development and point out any areas of interest. AND...they will appreciate your company and what's important to you. All of this will help streamline and potentially speed up your development process by beginning with the end in mind and having the proper support to keep you on track.
What considerations should you take when selecting a CRO?
2) No Surprises
Imagine you have worked for years on a technology you are sure is bulletproof. You'll have this product to patients in record time, pay back your investors, and be on your merry way. You apply for FDA approval, and all of a sudden, your dreams are slipping through your fingers. You realize that you've classified your device wrong; you went the 510(k) route when you needed to go De Novo with clinical, and you have no idea what this mistake will cost; now the light at the end of the tunnel is dim. By having a CRO at the proof of concept stage, you can start by classifying your device correctly, and therefore, put it through the correct development and approval pathway. Plus, you'll have an accurate idea of what the clinical trial will cost. Finally, your regulatory consultant and clinical project manager can work together to make sure you meet your milestones efficiently and effectively.
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3) Familiarity Does Not Breed Contempt
Everyone has been to a restaurant where they have the best experience with a certain waiter. You trust them when you ask what's best on the menu or when you ask for a drink recommendation. Having a trusted CRO throughout the early stages of your company will make you feel more comfortable in taking an outsider's opinion. You want someone who is as invested in the success of your technology as you are. They are your trusted advisors and know the in's and out's of your company just as well, if not better than you do. Also, with your regulatory consultant and clinical project manager being on the same team, miscommunications and gaps in information are almost non-existent.
We know CROs might seem like an unnecessary expense at first. But, once you account for the ease of communication between your regulatory and clinical teams, your streamlined timelines and cost estimates, and most importantly, the unparalleled support from your CRO, you'll find the partnership is worth every penny.
Proxima Clinical Research, Inc is a Contract Research Organization serving the new class of rising MedTech and biotech stars. Headquartered within the heart of the Texas Medical Center, the largest medical center in the world, we provide regulatory consulting, representation and clinical trial services to emerging companies. For more information about Proxima Clinical Research, Inc. visit www.ProximaCRO.com.
