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Tag Archives: enrollment
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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Social Media in Clinical Trials: Increasing Patient Recruitment
When you become sick with a virus or are seeking information about a diet, where’s the first place that you turn to for help? Is it the doctor’s office or the internet? A recent study showed that the percentage of … Continue reading
Posted in Clinical Trials, Social Media
Tagged advertisements, clinical trials, enrollment, FDA, guidance, HHS, patient recruitment, postmarketing, Social Media
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When Should You Write your Statistical Analysis Plans?
Recently in the LinkedIn Biostatistics group, one user asked: A client wants me to prepare final SAP [statistical analysis plan] shortly after protocol and CRFs are finalized for a Phase 3 trial, to submit to FDA prior to start of … Continue reading
Posted in Clinical Trials, Statistics
Tagged biostatistics, case report form, CRF, enrollment, FDA, LinkedIn, methodology, Phase 3, protocol, SAP, statistical analysis
1 Comment
