Regulatory and Clinical Strategy to Full Service Phase 1 - 4 Clinical Trials
GVI Clinical Development Solutions (CDS) is a Contract Research Organization (CRO) providing strategic consulting and hands-on clinical and regulatory support to biotechnology, pharmaceutical, diagnostic and medical device companies. With a flexible core staff of experienced professionals complemented by a comprehensive network of industry partners, CDS can be a valuable collaborator with your company.
We offer complete clinical trial management services in Canada and the US including site selection, monitoring, quality assurance, project management and post-market pharmacovigilance.
Accelerate Clinical Trails in North America
Take advantage of our North American regulatory expertise to add value and efficiency to your clinical trials. Let us help you 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.
Our accomplished regulatory affairs team will guide your project to ensure compliance with FDA and Health Canada investigational product 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 effective life cycle management of your products.
CDS can provide the full range of services from regulatory and clinical strategy consulting to full service conduct of Phase I - IV clinical trials. We have a customer service history of consistently delivering high quality results in a shorter time and at lower costs.
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.