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Tag Archives: protocol
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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Protocol Development: Focus on the Right Objectives
Every clinical study starts with the development of a clinical protocol, a document that describes how a clinical trial is to be conducted. Clinical protocols are not only a regulatory/GCP requirement, but are absolutely essential to ensure a clinical study … Continue reading
Posted in Clinical Trials
Tagged clinical trials, CROs, ethics committee, protocol, safety
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Clinical Trials in South Africa 101
South Africa has a mixture of both first and third world diseases and a large number of experienced research sites, making the country an excellent location for clinical trials in many indications. As we are a southern hemisphere country, recruitment … Continue reading
