Regulatory Insights
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Cytel's Response: FDA Guidance On Conduct Of Clinical Trials During The COVID-19 Pandemic
3/25/2020
The FDA recently issued a guidance on how the COVID-19 Pandemic may affect the conduct of clinical trials. Here are some key messages from the guidance along with some interpretations and recommendations.
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Current Challenges (And Solutions) In Global Regulatory Harmonization
3/11/2020
According to a Council of Foreign Relations report, ensuring a safe and secure healthcare marketplace that can provide innovative therapies is no longer an undertaking for a single nation. Larger harmonization agreement efforts, even with intervention by the World Health Organization (WHO), ended many times when country regulators bickered over who had the power to develop the standards and whose standards should be followed. The ICMRA, ICH, and other affiliated harmonization groups are acting to correct this.
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Using Egnyte For Life Sciences As GxP Repository
1/6/2021
Transitioning from the research phase to the clinical trial phase is a big step for any company, but it also means challenges, not the least of which means your electronic records need to comply with FDA 21 CFR Part 11 and GxP. In this democast, we will review how to deploy and use a GxP-compliant repository using Egnyte’s industry-focused platform, Egnyte for Life Sciences, without sacrificing usability or security, and without creating administrative overhead.
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How Leveraging Cross Collaboration Can Improve Standardization & Adoption Of An eRegulatory Solution
6/25/2020
The University of Cincinnati Cancer Institute (UCCI) collaborated with the UC Health Office of Clinical Research (OCR) to rollout an eRegulatory system based on an NCI Standard from Complion. This allowed for enhanced compliance with ability to identify trends and gather quality metrics across UCCI Disease Groups and OCR Departments to inform business decisions and process improvements.
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Mapping The New Landscape Of Orphan Drug Development
2/4/2020
The marketplace for orphan drugs is growing, and changes in the regulatory landscape are providing favorable conditions for collaboration in the area of drug development in rare diseases. Understanding the regulatory and operational nuances of orphan drug development can help sponsors position their promising compounds for clinical and commercial success.
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The Convergence Of GDPR, The HIPAA Security Rule, And Part 11 On U.S. Clinical Research
4/1/2020
As electronic research systems are increasingly relied upon to store participant data, report results, and confirm informed consent, regulatory bodies around the world are re-examining old regulations and developing new ones. Discover what it means for US research.
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Accelerating The Recovery – Design And IRB Review Of Safety Monitoring Plans During COVID-19
8/19/2020
How do remote visits and remote data collection impact participant safety monitoring? This article presents ways to satisfy the regulatory obligation to conduct safety and data monitoring in this new remote research world.
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Drug Development For Rare Disease And Oncology During The COVID-19 Pandemic
10/27/2020
How has the pandemic affected patients in the search for treatments for rare disease and cancer? How have clinical trials and regulatory activities been impacted? This article outlines some of the findings from a recent virtual discussion with Parexel experts and representatives from the patient advocacy group, Sara’s Cure.
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Tips For Submitting Expedited Review Studies
4/1/2020
Becoming familiar with the expedited requirements is a good way to ensure you can navigate the review process effectively. Set yourself up for success by reading 6 tips for submitting research studies for expedited review.
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Establishing A Culture Of Inspection Readiness
7/7/2020
Inspection readiness is not simply something you do; it is a state of operation. It is optimal good clinical practice and an ongoing organizational discipline. Learn the processes that must be completed to establish a culture of inspection readiness.