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product design

We can help you design a product that captures the needs of the end-user and the health-care provider by incorporating input from health-care professionals, luminaries, and industrial collaborators. If technology constraints exist, we can assess and determine the most appropriate application of your technology so as to satisfy the market requirements.

product development

We can provide pharmaceutical companies with guidance in drug substance and drug product development, validation, and preclinical trials. We can provide device and diagnostic companies with assay, process, and device optimization, statistical analyses, and product and process scale-up and automation.

clinical trial design, management, and biometrics

We can design and manage your clinical trial or participate within your infrastructure and/or other contractors. Protocol writing, case report form design, budget development, institutional review board, site monitoring, data management, biostatistical analysis, and composition of study reports are all services we provide through Vision Clinical Research. We are well versed in Phase I-IV pharmaceutical trials and in all manner of device and diagnostic trials.

regulatory submissions

We can author pre-Submissions, IDEs, Risk Determinations, 510(k)s, PMAs, INDs, NDAs/CTDs, and CE Mark Technical Files. We can act on your behalf in correspondence and negotiation with FDA. Our recent track record in 510(k) clearances, PMA approvals, and IND and NDA approvals is stellar. Please refer to recent announcements on our Home page and to details of our work in these areas on our Projects page.

manufacturing

We can provide advice and guidance on compliance with good manufacturing practices, statistical process control, quality control, quality assurance, and process enhancement. We have performed troubleshooting of both pharmaceutical and device/diagnostic manufacturing processes. Please refer to the Projects page for some examples.

presentations, publications, medical education

We can create and present oral and poster presentations for scientific meetings and author manuscripts and technical marketing literature. We are recently published in several prestigious scientific journals. We have also authored Continuing Medical Education (CME) programs for various clients. See the Biography page and the associated curriculum vitae for M. Sarno for recent publications.

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