Quality in Practice.
Our company has previously retained CDS to work with us on two clinical trials. The second assignment, which was the larger of the two projects, involved overall project management for a 31-site, 360-patient trial in the hospital setting in the US and Canada. CDS did an excellent job in the site management of the trial. The CDS team developed a strong rapport with the PIs, clinical trial specialists and others at the sites. This permitted the study to proceed well through site qualification, trial execution, monitoring and site close-out. The team at CDS was large enough to handle the demands of a 31-site trial, yet small enough to allow us to get to know all the members of the CDS team on a first-name basis.
CDS was contracted by Medicure to audit four clinical sites (totaling ~1200 patients) located in the Netherlands in anticipation of a scheduled audit by the U.S. Food and Drug Administration. The in-house preparation of the audit was detailed and comprehensive, leading to a productive and successful two week on-site audit of the clinical sites. Regulatory guidance provided by CDS for the audit proved to be an essential component for the success of this project. After CDS completed its audit of the four clinical sites, the subsequent FDA audit found all four sites to be satisfactory.I have no hesitation whatsoever recommending CDS for its clinical study auditing services.
The FDA regulatory support and leadership provided by GVI-CDS has allowed us to reposition our product and completely transform our business. I can’t say enough about the hard work, diligence and creativity they’ve provided to us as we negotiated a unique supplemental NDA approval, user fee waivers, and much, much more. Truly outstanding!When our company was forced to downsize, GVI-CDS provided a contemporary, cost effective, and professional solution to our data safety management needs. Their pharmacovigilance staff support and work as part of our team.”“GVI-CDS is providing cost-effective and responsive study management and monitoring for our multi-site United States interventional cardiology study. They are an ideal match for small to mid-size pharma and biotech companies looking for leadership of in-hospital clinical studies, and are particularly experienced & networked the field of cardiology.
GVI-Clinical Development Solutions has been providing monitoring support for the Canadian VIGOUR Centre since 2008. They consistently seek and have delivered very high quality, experienced monitors to align with our needs and objectives over the past 7 years. Their flexibility and willingness to support the needs of our projects and consistently deliver within the required timelines is valued. As a trusted partner we look forward to the continued collaboration with their team and monitors on current and new projects.
We have worked with the team at CDS for over 3 years on our clinical development program. We have found CDS to be very responsive to Sponsor needs, with excellent attention to detail and follow through in all aspects of our clinical program.