Clinical Research

We are a full-service Clinical Research Organization. We can handle all aspects of your clinical research programs, or supplement your in-house teams as needed. Our staff is cross-trained in Quality, Regulatory, and Clinical Operations. This in-depth cross-training allows us to quickly and easily identify regulatory or quality issues early on in a study. Our clinical studies are always managed by a medical device engineer whose training and experience allow them to communicate study events to your development team in common vernacular. Clinical Studies require constant learning and adjustments and having the right team in place can make all the difference.

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  • Clinical Strategy Development

    Are you not sure what your development plan should look like? Do you need someone to review your plans? Would you like support at an FDA meeting? Our Clinical Study experts can help you with all these strategic aspects and more.

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  • Investigator Selection

    Do you have a product but lack a network of medical professionals to run the study with? Are you unsure what to look for in an Investigator, site and staff? We can advise or completely manage the process for you. Years of experience have taught us how to identify a good investigator and how to determine those to avoid. Use our experience to make your study better.

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  • Protocol Development

    Did your protocol include all the rights elements for the FDA? The IRB? Is your inclusion/exclusion criteria too tight? Is the data you are collecting meaningful? Did you consider all the stakeholders and their needs? We can develop a protocol from scratch or we can review your protocol to make sure it aligns with preferences of the regulatory agencies. It is always great to have a second set of experienced, knowledgeable eyes reviewing a complex document.

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  • Study Management

    We can fully manage your study from IDE to FDA, and all the steps in between. Our skills, cross training, and knowledge make all the difference. We do this every single day. Let us help you and your team get your study completed successfully.

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  • Database Development

    Our staff is fully trained and certified using both ClinCapture, as well as Viedoc systems. We can complete the database builds, validations, and any changes that might be needed along the way. And if we are managing the whole study for you, the same team that made your database system are going to be the same team running the study. This makes changes in your study easy and cost effective. And that combination is the best of all worlds.

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  • Clinical Review Committee Management

    Do you need an independent 3rd party to help facilitate a review meeting? Would you like that 3rd party to have experience with clinical studies, statistics, medicine, engineering, be personable and work with FDA reviewers and physicians every day? Great, we have lots of folks that can help!

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  • Medical/Technical Writing

    We have services to support medical writing for both regulatory needs (FDA, narratives, IRB, etc.) and medical writing services to help support publication . Our team can facilitate and speed your publications along.

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