GVI Clinical Development Solutions (CDS) is a Contract Research Organization (CRO) with a flexible core staff of highly experienced professionals complemented by an extensive network of collaborative clinical industry partners. 

CDS can be a valuable partner for your company. Contact us as you are mapping out your regulatory and clinical path, looking for experienced site monitors, full service clinical outsourcing, or post-market pharmacovigilance. CDS provides cost-effective quality services matching your company's unique clinical needs.

GVI CDS provides strategic consulting and hands-on clinical development support to biotechnology, pharmaceutical, diagnostic, medical device, and nutraceutical companies.

Accelerate Clinical Trials in North America

 

Take advantage of our North American regulatory experience and expertise to add value to your clinical trials. Let us help you navigate and streamline your clinical trials from applications of New Chemical Entity (NCE),  Investigative New Drug (IND), First in Human (FIH) trials, and Clinical Trial Application (CTA) submissions through to final approval with the US FDA or Health Canada.  

We also offer complete clinical trial management services in Canada and US , including site selection, monitoring, safety reporting to the appropriate regulatory agency , quality assurance, and project management.


Regulatory

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Our accomplished regulatory affairs team will guide your project to ensure compliance with regulatory agency requirements for investigational product applications and marketing authorization submissions. We will navigate you through the most cost-efficient routes to get your products on the market in the shortest timeframe possible.   Our expertise extends throughout the post-marketing phase, ensuring ongoing compliance, and development of innovative strategies for implementation of effective life cycle management of your products.

 

Clinical Trials

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Through our unique business model, we can provide the full range of services from regulatory and clinical strategy consulting to full service conduct of Phase II-IV clinical trials. Continued positive client feedback speaks to our capacity to consistently deliver high quality results in a shorter time and at lower costs.

 

Pharmacovigilance

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Our pharmacovigilance database and our extensive knowledge of regulations for adverse events in the United States, Canada and Europe enables us to plan and implement your adverse event management for clinical trial and marketed products.