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news roundup
Sponsors and researchers are now considering a new streamlined route for reviewing applications for clinical trials in the UK. The scheme, known as the Combined Ways of Working (CWoW), provides a path to overcoming the regulatory differences that exist within the UK itself. As it harmonizes internally, it also will align its practices with the EU’s new clinical trial regulation when it comes into effect.
Asia-Pacific biotech CRO Novotech has been selected for the Komipharm International clinical trial of Panaphix as a potential treatment for coronavirus - Covid-19. Komipharm is seeking to expand the use of Panaphix to cover the treatment of Covid-19 through this trial.
Madrid, Spain-based CRO Pivotal has acquired Ghent, Belgium-based Akcelis BVBA, a provider of patient enrollment and retention solutions for clinical trials, using highly predictive software analytics.
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Use of RWE in Clinical Development to Enhance Regulatory Submission
Tuesday, April 7, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Articles |
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This case study from the Michael J. Fox Foundation for Parkinson’s Research describes a study to better understand Parkinson’s biomarkers to highlight the opportunities and challenges in site selection.
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Outsourcing to CROs: Expediting Clinical Operations or Oversight Nightmare?
Tuesday, April 28, 2020 1pm EDT | 12pm CDT | 10am PDT
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In this article, Ken Getz delves into the results from Tufts CSDD and The Avoca Group’s recent study that benchmarked the vendor qualification assessment process. The results highlight a demanding area that has often been discounted as simply a cost of doing business but for which there are process improvements and efficiencies to be gained.
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Blog Posts
From one site perspective, the focus is shifting towards staff preparedness for infectious disease prevention, such as ensuring proper medical protocols are followed to avoid Coronavirus transmission. Unfortunately, these activities are taking away valuable focus and resources needed for running clinical trials.
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