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Laurie Meehan
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So proud to be part of Polaris!
So proud to be part of Polaris!

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Why do regulators care so much about Delegation of Authority logs? Because they provide evidence that study tasks have been assigned only to staff members qualified to carry them out. By reviewing DoA logs, monitors can help their sites comply with the new ICH E6(R2) requirements for PI supervision and staff qualifications.
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Why do regulators care so much about Delegation of Authority logs? Because they provide evidence that study tasks have been assigned only to staff members qualified to carry them out. By reviewing DoA logs, monitors can help their sites comply with the new IE6(R2) requirements for PI supervision and staff qualifications.
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An interesting read about the power of saying “Yes, and…” instead of saying “Yes, but…”
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Sponsors and CROs want to know that quality management at your site is a continual process. Don’t have formal QC procedures in place? You can start by controlling and guarding against these usual suspects.
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We've played with a lot of these "trial matchmaking" tools: CenterWatch's tool, CISCRP's tool, Lilly's TrialGuide (excellent), CureLauncher, TrialX, SmartPatients, PatientsLikeMe,... This "Registry of the Future" design from TransCelerate will have some very helpful features, if implemented. Check out the 3-minute video demo. (We're very distracted by the acronym, though: ROTF. Where's the "L"?!)
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When time is short, what should your pre-study visit focus on that will help you predict how much oversight you can expect from a prospective PI? (A lesson from my grandfather.)
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Need a quick reference for clinical research laws, regulations, and guidelines from 130 countries? OHRP’s annual compilation is out -- now with social and behavioral research.
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PDUFA allows FDA to evaluate the safety and efficacy of new drug indications (after the drug's initial approval) using real-world evidence alone, i.e., with no randomized clinical trial. Real-world evidence could include observational studies and data from registries, health plans, EMRs, and smart devices. Via +Applied Clinical Trials
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An excellent article about pharmaceutical companies' disconnect between manufacturing and clinical, FDA #GMP inspection improvements, and inspection prep.
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