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May 14, 2024
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With over 30 years of unparalleled expertise in the Pharmaceutical, Biopharmaceutical, and Medical Diagnostic sectors, we bring a wealth of experience to every project.
With over 30 years of unparalleled expertise in the Pharmaceutical, Biopharmaceutical, and Medical Diagnostic sectors, we bring a wealth of experience to every project.
A trusted partner in clinical research
Empowering individuals to achieve optimal health through innovative solutions and personalized care.
Expert guidance through regulatory processes, including FDA interactions, INDs, BLAs/NDAs
I maintain relevant certifications that validate our expertise and ensure the highest quality of service delivery.
25+ Years of experience in clinical research, development, and clinical operations. This includes, direct managerial responsibility for Clinical and Medical Operations Departments in the US and Europe, direct managerial responsibility for clinical studies, project management of US and European clinical studies, management of clinical research personnel.
Direct hands-on experience in the writing of IBs, protocols, CRFs, statistical analysis plans, Clinical Study Reports, Orphan Drug Applications, IND’s, BLA’s/NDA’s, Type B and C Meeting Briefing Books, pre IDEs, and CE Mark applications.
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(760) 470 3311
Over the years has developed a diverse working knowledge of all phases of clinical development in pharmaceutical, biotechnology, and medical diagnostics. An invited speaker to numerous industry conferences on a wide range of topics dealing with clinical and medical operations.
Direct experience with coordination of large multinational pivotal clinical studies that have led to the approval of several novel drugs (US and EU), drug applications, and diagnostic devices (HYQVIA, MabThera SC, Herceptin SC, Anzemet®, Infergen®, NGAL CE Mark, and Nutre-Store L-Glutamine®).
Participated in the first successful electronic BLA submission to the FDA and has participated in numerous meetings with the FDA. Over the years has developed a diverse working knowledge of all phases of clinical development in pharmaceutical, biotechnology, and medical diagnostics.
European clinical studies, management of clinical research personnel, and direct hands-on experience in the writing of IBs, protocols, CRFs, statistical analysis plans, Clinical Study Reports, Orphan Drug Applications, IND’s, BLA’s/NDA’s, Type B and C Meeting Briefing Books, pre IDEs, and CE Mark applications.
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Reach out to us via email at
[email protected].
Give us a call on your mobile phone at
(760)470 3311.
Explore our professional network on LinkedIn by visiting @daveconway1/
Our goal is to provide a seamless experience from start to finish.
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Welcome to WordPress. This is your first post. Edit or delete it, then start writing!
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.
