Final ICH GCP E6 R2: Sponsor Quality Management Trailer
ICH GCP E6 R2 provides significant detail on implementing a system of quality management with a focus on a risk-based/risk management approach for the trial …
Tag Archives: clinical trials…
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Webinar: Refocusing on Risk Mitigation in Starting Clinical Trials
While risk management efforts in drug development have focused mostly on post-marketing drug safety, the clinical trials process has its own mix of potential …
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Risk Based Monitoring QbD and protocol design webinar
In this short but informative extract from our online academy course Peter provides practical advice on designing protocol writing rules.
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Metric Assessment Within Strategic Partnerships
Jonathan Zung, PhD of Bristol-Myers Squibb, Jamie Macdonald, CEO of INC Research, Ciaran Murray, CEO of ICON plc and Peter Carberry, MD of Astellas speak about what metrics they use and how they assess them within their partnerships during their panel “Making CRO-Sponsor Partnerships Work” from DIA2013.
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The IRELAnD Study – Dr. Fionnuala Breathnach
Dr. Fionnuala Breathnach presents the findings of the IRELAnD clinical trial: Aspirin for Optimising Pregnancy Outcome in Pre-gestational Diabetes. Pre-gestational diabetes is a large risk factor in the development of preeclampsia which can present problems for both the mother and the baby. Low doses of aspirin have been implicated in the prevention of preeclampsia. IRELAnD […]
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PAREXEL – Paul Evans Discusses Clinical Feasibility Session at PCT 2015
So at the session I was involved in today at PCT, we had a pretty wide range of discussion about feasibility, how we can improve feasibility and how we can use the data sources available to us to get better outcomes from our feasibility. We also extended that into how we can engage patients better […]
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An In Depth Look At Clinical Research Feasibility Surveys and Site Selection Visits
An In Depth Look At Clinical Research Feasibility Surveys and Site Selection Visits http://www.TheClinicalTrials.guru Call/Text: (949) 415-6256 Follow Me On: SnapChat: username is dansfera Instagram: https://instagram.com/dansfera Twitter: https://twitter.com/TheRealDanSfera Facebook: https://www.facebook.com/dansfera LinkedIn: https://www.linkedin.com/profile/view… LinkedIn Clinical Trials Guru Leaders Group: https://www.linkedin.com/grp/home?gid…
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Study Feasibility – Eliminating Low and Late Enrollment Trailer
This course is designed for Sponsor and CRO personnel responsible for protocol design and development, country allocation, site selection, and study feasibility assessments. It is a well-documented fact that the current study feasibility assessment process is inefficient and is incapable of identifying the best investigative sites to conduct a clinical trial (typically 35% of study […]
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CLINICAL TRIAL MAGNIFIER Site Marketing Video
http://clinicaltrialmagnifier.org/site-marketing/ Marketing of Clinical Study Sites Site marketing activities Marketing of a company or product is an art of its own. However, marketing of a clinical study site is different from other marketing activities since the pricing of the services is quite fixed and because the client characteristics are well defined. Still, there is a […]
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Melissa Rosenkranz, PhD – “After active controls in meditation studies: Where’s the beef?”?
Part 9 of 12. This talk by Melissa Rosenkranz, PhD, Associate Scientist, Center for Investigating Healthy Minds, University of Wisconsin-Madison, was given as part of the 2015 UC Davis Center for Mind and Brain research summit “Perspectives on Mindfulness: the Complex Role of Scientific Research” on May 21, 2015. The playlist for the full conference […]
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Risk Based Decisions Trailer
All clinical trial teams, sponsors/CROs, investigators/sites, and IRBs/IECs should assess their current practices in order to identify gaps in support of risk-based project decisions. Proactively at the start of the project and during issues management, risk management should be part of a quality system that supports GCPs for each project’s unique challenges. The GCPs alone […]
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MDICx webinar: Advancing U.S. Early Feasibility Studies – CDRH and MDIC Initiatives
MDICx webinar – Advancing U.S. Early Feasibility Studies – CDRH and MDIC Initiatives November 17, 2015 Speakers: Owen Faris, PhD | Clinical Trials Director (Acting), CDRH FDA Carla Wiese | Policy Analyst, CDRH FDA Karim Benali, MD | Vice President and Chief Medical Officer, Abiomed Vicki Pearson | Vice President, Regulatory Affairs, Medtronic Aortic and […]
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