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In this ISSUE

The Regulatory Debate Around Pre-approval Product Access

Fighting Back Against Drug Skepticism

Academic Research Under the Clinical Trial Regulation – Partial Relief?

Clinical Operations
Non-Adherence: A Direct Influence on Clinical Trial Duration and Cost
As clinical trials remain costly and continue to increase, the promise of novel initiatives gives hope that trial duration and cost impact will drop. However, biopharma continues to overlook one element that affects study timelines: patient non-adherence.
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Planning Gene Therapy Research? Prepare for institutional biosafety committee (IBC) Review with these tips from the Biosafety Officer at a leading IRB.
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Patient Centricity
Patient Centricity and Convenience? Request a Lyft
The recent partnership between Continuum Clinical and Lyft has introduced the convenience of transportation into the hands of patients. Nariman Nasser, VP of Site Optimization at Continuum Clinical, elaborates on this partnership.
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Talking the Patients' Language – the importance of effective, patient-centered engagement
Live Webinar: Tuesday, June 6 at 8:00 am EDT
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Clinical Operations
Mobile Nursing - Bringing the Trial to the Patient
The ability to carry out clinical trial visits in a patient's home, workplace or location of choice is still an uncommon concept. However, mobile trained research nurses can expand on this idea by conducting 'off-site' study visits.
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Winning the RAT race: A new Center of Excellence to drive development of regenerative medicines
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Medical Devices
New Trials Law in France: Advantages for Medical Device Studies
The new law on research in France introduces changes for the medical device industry by facilitating the conduct of postmarketing studies. Devices will no longer have to be provided free of charge for low-risk interventional studies making France a possible location for such trials in the future.
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Is Your CTMS Working for You? Unify and Optimize Your Approach to Clinical Trials
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Regulatory Affiars
Digging Medicines Regulation Out of the Brexit Hole
As negotiations between the UK and the remaining 27 members of the European Union commence in the next month or so, questions of trade, IP protection and of free movement will emerge.
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Calendar
/ T3: Trials, Tech and Transformation 5/11-5/12 /

/ Clinical Trial Supply and Logistics Forum 5/22-5/24 /

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Lisa Henderson
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