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Tag Archives: GCP
Project Management for Biotech Companies
In today’s fast paced, high pressure world of drug development there are multiple factors that can and do affect marketing success. Large organizations understand the value that project management can contribute to a successful project. The smaller companies tend to … Continue reading
Posted in Clinical Trials, Project Management, Regulatory Strategy
Tagged biotech, Cato Research, central labs, clinical investigator, clinical research, clinical trials, CMC, CROs, drug development, drug product, efficacy, enrollment, FDA, GCP, GLP, GMP, ICH, manufacturing, nonclinical research, project management, protocol, safety, site selection, SOP, stability, toxicology
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Choose Canada for Your Next Clinical Trial
When it comes to the state of the life science industry in Canada, the critics are numerous. The past two to three years have been difficult and those that lie ahead are still quite uncertain. With the growing competition at … Continue reading
Posted in Clinical Trials, Health Canada
Tagged Canada, clinical research, clinical trials, CTA, Electronic data capture, enrollment, GCP, Health Canada, patient recruitment, tax credit
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India: The next up and coming location to run clinical trials?
Until recent years, clinical trials have been conducted primarily in the US and in Europe, due to higher health standards and overall standard of care for patients. However, more and more pharmaceutical companies and contract research organizations (CROs) are … Continue reading
Posted in Clinical Trials, Industry News
Tagged clinical trials, CROs, EMA, FDA, GCP, ICH, India
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Introduction to Good Clinical Practice Webinar Slides
Earlier today, Cato Research hosted a webinar titled, “Introduction to Good Clinical Practice.” Arlene Lund, a Clinical Study Manager in our Montreal, Canada office gave a great Good Clinical Practice (GP) overview and left attendees with a basic understanding of … Continue reading
Posted in Clinical Trials, Webinars
Tagged clinical trials, drug development, GCP, webinar
2 Comments
OIG Report Shows Increasing Use of Foreign Clinical Trials in Marketing Applications (and Challenges for the FDA)
There are no foreign lands. It is the traveler only who is foreign. – Robert Louis Stevenson Global. That’s one of the buzz words/ideas that has gripped modern drug development. In particular, there is a notion that foreign countries represent … Continue reading
Posted in Clinical Trials, FDA, Industry News
Tagged biologics, BLA, clinical trials, drug development, FDA, GCP, IND, inspections, marketing application, NDA
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