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First in Human
First in Human refers to the phases of clinical research in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases start with testing for safety in a few human subjects, then expand to many study participants to determine if the treatment is effective. Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays.
Have a First in Human milestone and need a quality resource to help the team line up the product development needs to ensure a safe and effective product is ready?
Contact us to learn how we can help you meet these goals.
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Cannon Quality Group (CQG) was founded in 2010 as a full-service outsourced quality management company serving the medical device, Medtech, pharma, IVDR, SaMD, and general life science community with right-sized quality management system solutions.
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Cannon Quality Group, LLC
77 Front Street
Danville, CA 94526
Writing Templates
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Available Templates
Clinical Evaluation Protocol & Report
Accurately document your clinical trial evaluations with our meticulously crafted Clinical Evaluation Protocol & Report Template, ensuring adherence to regulatory standards and efficient data reporting. Streamline your review process, from protocol to comprehensive reporting, with our user-friendly template, designed to clearly outline the clinical evaluation review process.
Literature Search Data forms
Elevate your literature search review process with our Literature Search Data Form, which offers a structured approach to identify and document relevant studies, guiding you in extracting and synthesizing key information. The data search form empowers you to conduct comprehensive reviews with efficiency and precision, ensuring a robust foundation for your literature review report.
Literature Search Protocol & Report template
Take advantage of our Literature Search Protocol & Report Template. This comprehensive tool provides a systematic framework for designing and executing a meticulous literature search, ensuring adherence to best practices. Seamlessly transition from defining search strategies to synthesizing findings, empowering your research with a structured and efficient approach that aligns with the highest standards of excellence.
Data Extraction form
Utilize the data extraction form as a tool to record pertinent information from studies identified in your literature search.This form ensures a systematic and organized approach to extracting key data from the literature search process, ultimately accelerating your data synthesis and analysis.
Declaration of Interest (DOI) form
Leverage the Declaration of Interest (DOI) form to ensure compliance with EU Regulation (EU) No. 536/2014 on Clinical Trials.
Notes: Post market surveillance, PMS, periodic safety review, PSUR, Clinical investigation, CEP, CER, literature, safety and performance, state of the art, MDR, IVDR, MEDDEV, clinical
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