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Clinical and Regulatory Affairs Professionals

Information to help with your regulatory strategy.

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Clinical and Regulatory Affairs

SmartTRAK is a great knowledge base for Clinical and Regulatory professionals. Our expansive database provides an easy way for teams to familiarize themselves with the competitive landscape including products currently on the market or in various phases of approval. It also allows clin/reg team members to keep a finger on the pulse of the market and market innovations including new product launches, patent applications, 510K clearances and more.


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of the Top 15 Orthopedic Companies Subscribe to SmartTRAK


of the Top 15 Advanced Wound Care Companies Use SmartTRAK Business Intelligence


of the top 9 Extremities Companies Depend on SmartTRAK

How are Clinical and Regulatory Professionals using SmartTRAK?


Real-Time News, Market Trends, and Analysis 

SmartTRAK gives Clinical and Regulatory Affairs Professionals a top-level view of the market. Our news and analysis make it easy to see where the market is heading, what clinical studies are underway, and what regulatory paths are being pursued. SmartTRAK keeps you in the know.


Due Diligence and Pre-market Regulatory Strategy

SmartTRAK provides Clin/Reg professionals with an easy starting point for prepping for a new product introduction and the potential clinical and regulatory pathway required for approval.  

Our Product Profiles are robust and give an in-depth up-to-date view of all the information  relating to clinical studies and regulatory approvals including links to clinicaltrials.gov and FDA approval letters.neuro-product-profiles


Company Profiles provide a quick top-level overview of the company including a summary of revenues, products, acquisitions, and strategic alliances.



Product Explorer allows you to quickly sort through the competitive landscape and identify competitive products and their regulatory status in seconds. 


Clinical Trial Landscape Visibility

SmartTRAK provides an easy way to monitor the clinical trial landscape.  Important clinical study developments, timelines, and approvals are reported as soon as they occur in our Daily Updates all with links to the FDA's site of company's press release. 


Perspective Article Trends and Developments in Biomedical Solutions


Quick Predicate Searches

Our Gap Analysis tool enables you to quickly zero in on competitive products in order to quickly identify like products on the market or under development. Simply click on the link to go to the Product Profile where you will find a summary of clinical trials and links to FDA approval letters to gain insight into study design and predicates used.


IP and Patents

Tired of wading through patents to find those that are relevant to you and your business? Our team of experts does it for you; providing you with the latest in patent applications, and patent approvals straight to your inbox as they happen. 




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"Every morning I get up and turn on the computer and I've got my dashboard right there, essentially telling me what's new in the space; who's doing what, what new clinical studies are being conducted, and where the focus may or may not be shifting. It also helps me identify new opportunities in which we can potentially expand our business"

C. Scott Brown, Director Strategic New Market Development, Integra LifeSciences.



Providing a New Look at Patents &
IP Trends

icon_challenge THE CHALLENGE
Medium Short Orange Line The Head of R&D for a biotechnology company was interested in patent/patent application trends for a specific subsegment of orthopedics. He wanted an easier way to view the IP in the market and knew SmartTRAK’s team routinely reported on competitor patent and patent applications. 

icon_smarttraksmart SMARTTRAK SMART
line_purple The Head of R&D contacted SmartTRAK and asked for help in further drilling down into his particular market segment. SmartTRAK’s team of experts created a custom deliverable that met the customer’s needs. SmartTRAK’s Daily Updates, Financial Dashboard and Company Profiles were used to provide understanding and quantify market and patent trends in the space. The SmartTRAK team triangulated SmartTRAK data with additional sources to create a robust report.
icon_results RESULTS
Slightly Less Tall Blue Line 175px The client was thrilled with the SmartTRAK report which outlined the most recent patent trends and common denominators, along with a table grouping the patent/patent applications by technology classification and the common trending denominators. The R&D executive stated the report met his specific needs and, in addition, the experience also provided him a new way of looking at patents/patent applications and the market.

Ready to Learn More?

Get in touch with us to find out more about how SmartTRAK can help you.

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