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Our Services
How We Help
Regulatory Submissions
The Insight Medical team is well versed in preparing all types of regulatory submissions in various countries around the world. Whether you need assistance with the Pre-Submission process and are seeking guidance on how to position your key messages to the regulatory agency or are looking for someone to develop all of your submissions and interface directly with FDA on your behalf, we have the experience. Our experience extends from PreIND, PreIDE, IDE/IND, 510(k), PMA and BLA applications in the US and CE Mark Dossiers in EU.
Strategic Consulting Service
A successful product introduction begins with a well crafted plan. At Insight Medical, we will work with your team to develop a comprehensive Regulatory/Clinical Strategy that includes preclinical and clinical evaluations to optimize the product approval process. The strategic plan includes formulating the key marketing claims that tie to the regulatory pathway and ultimate marketing approval.
Due Diligence
Our expertise in understanding unmet medical needs and how they interface with clinical, technical and regulatory requirements provides us with a unique ability to review product development and clinical trial work to guide a valuation proposition. With increasing pressures on fundraising, regulatory requirements and readiness become key drivers for decision makers. We can help you prepare for messaging if you are a company and have a proven track record of performing due diligence assessments for investors.
International Study Design
The world is becoming much smaller as technology expands, making world-wide clinical trials a much more efficient method for collecting valuable clinical trial data in support of clinical messaging/white papers as well as supporting regulatory requirements. The Insight Team is ready to assist you with designing studies that are optimally positioned to support your clinical needs. We can help with PMCF plans/designs, FIH programs as well as clinical trial designs to support an International Regulatory Marketing Submission.
Understanding Your Clinical Trial Results
A key aspect to successful clinical trial execution is the "sense making" of clinical trial results. Understanding and interpreting FIH study outcomes can result in an efficient and effective pivotal trial design. Interpreting the critical pivotal trial data provides the backbone for key messaging to regulatory stakeholders as well as the clinical ecosystem. Often it is more than just summarizing the information as key messaging is often tied to interpretation of risk and benefits to the patient and how that impacts the reimbursement pathway. The most effective key messaging is utilized in presenting to the FDA Advisory Committee. Clear and Concise Messaging is the key to obtaining a positive outcome. We have partnered with multiple clients to guide them through the risk/benefit balance and establishing a successful messaging platform.
Preclinical Trial Designs
Preclinical studies, both bench and animal, are paramount in effectively establishing the basis to support a marketing claim for a low risk device or to ensure the initial safety profile of a product to support a clinical trial application. Our team of technical experts can guide you through the process of evaluating the most efficient plan for establishing an optimal preclinical plan.