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CRO Report Notes Issues With Clinical Applications
By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical
Veeva has released its annual CRO report which examines progress toward modernizing clinical operations. The Veeva 2020 Unified Clinical Operations Survey: Annual CRO Report gathers the experiences and opinions of CROs around the world and details drivers, barriers, and benefits of a unified operating model from the CRO perspective.
The findings of the report show CROs are driving the adoption of modern clinical applications to increase the efficiency, quality, and speed in clinical trials. A whopping 99 percent of CRO respondents reported the need to unify clinical applications, while 90 percent noted they have or plan to have an initiative in place to do so.
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How To Cut The Negative Impact Of Protocol Amendments
Social distancing laws in response to the COVID-19 pandemic forced dramatic changes to procedures for the collection, monitoring, review and analysis of clinical data in trials. Regulators have responded with an appropriate degree of flexibility but some CROs initially struggled to manage the impact on clinical trials.
Protocol amendments are more common in clinical trials than you might think. A 2017 article by the Tufts Center for the Study of Drug Development (CSDD) found 59% of clinical trials have at least one protocol amendment (PA). Why should this matter? Protocol amendments have a major impact on CRF design, which typically lead to delays and system downtime for CRF updates, and ultimately increased costs for sponsors. It’s important also to highlight the frustration experienced at sites due to their inability to enter data during system downtime, which leads to backlogs in data entry.
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Sunday, February 28, 2021, was Rare Disease Day. With so much
focus on COVID-19 throughout 2020, it s important to recognize
the continued work done in rare disease drug development by
sponsors and FDA throughout 2020. In addition, a number of policies
implemented in response to COVID-19 are expected to have a positive
impact on rare disease drug development going forward. Yet, the
lasting nature of these policies, post-pandemic, remains uncertain,
creating an opportunity for rare disease drug sponsors to be
proactive in engaging with regulatory authorities and the patient