Our Expertise
It can be overwhelming for any early-stage company to make plans for clinical development activities. It is especially true for companies outside the US who want to expand their presence to the United States. Connecting you to the greatest resources the largest medical center in the world has to offer and providing you with 23+ years of experience in the scientific and medical field, ComteXBio will support and facilitate your transition.
Strategy and Partnerships
We strategize with your executive team, review your product specifications and work with subject matter experts to support a sound regulatory pathway to successful US FDA approval of your product. We act as, or partner with, your clinical development team to select clinical sites, contract research organizations, other consultants, to represent your company in national and/or international meetings.​
Clinical and Regulatory
Leveraging our extensive local and international network, we facilitate access to relevant KOLs and expert clinicians, and through a high level of communication gather insights on optimizing product fit and clinical trial designs. We work with you to develop your clinical/regulatory pathway and write your protocol, informed consent form, case report forms and other compliant clinical documentation. We select and oversee clinical sites and CROs to support you in generating real world evidence. We guide you through the planning and submission of regulatory documentation along with conducting regulatory interactions.
Why ComteXBio?
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1. You are targeting the $198 Billion* US medical device market in the world’s largest healthcare market. The Texas Medical Center in Houston is the 8th largest business district in the US!
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2. You want to leverage access to patients and resources to complete your required clinical studies faster. The Texas Medical Center enrolls patients in 20% of all US clinical trials and sees over 10 million patient encounters per year.
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3. I possess the expertise, know-how, a network and the motivation to facilitate your success and stand ready to help you, here in Houston!
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