Industry Insights
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Looking Beyond The Pandemic: Ensuring Data Integrity Post-COVID-19
6/4/2020
Trials that have continued through the pandemic are now producing data, and sponsors are having to adapt analysis and reporting strategies to fit their current circumstances. Data integrity is paramount now more than ever. This article shares strategies and processes being utilized by key players in the industry and provides insight into how to best proceed in the future.
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Clinical Trial Budget Challenges & Opportunities
6/3/2020
Protocol complexities are becoming ever more complex, and with it, so has the clinical trial budgeting process. Plagued by multiple stakeholders using disconnected systems across the globe, delays and increased costs in study start up follow. Discover what sponsors need to consider in order to achieve first patient in as swiftly as possible.
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Key Questions For The Effective Implementation Of eCOAs In Your Clinical Trial
6/2/2020
With the industry-wide push towards patient-centricity, electronic clinical outcome assessments (eCOAs) have become a more widely used strategy to streamline patient data collection, provide real-time access to data for review and monitoring, enhance patient engagement, and improve the integrity and accuracy of clinical studies. Here are a some answers to some commonly asked questions about eCOAs.
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The Sunsetting Of Rare Pediatric Disease Designation
6/2/2020
As with other incentive programs, FDA created the Rare Pediatric Disease (RPD) designation to encourage drug development in products with questionable financial viability. As things currently stand, FDA is sunsetting the program, and may not award priority review vouchers for any product unless the product has received RPD designation by September 30, 2020. How can a sponsor increase the chances of a favorable first round review with such a short window of time remaining?
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COVID-19 Treatment Development: Updates And Recent FDA Guidance
6/2/2020
The FDA continues to release additional information and update their website as the COVID-19 pandemic continues and both regulatory professionals and drug developers react to the potential for novel and repurposed products to treat COVID-19. This blog addresses recent changes to the Coronavirus Treatment Acceleration Program (CTAP) webpage as well as two new guidance documents for the COVID-19 treatment development.
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Inside Novo Nordisk’s Patient Advisory Board Meetings
6/2/2020
Novo Nordisk's first DEEP (Disease Experience Expert People) Advisory Board meeting brought together leaders of patient organizations, patient advocates, and patients from five countries to participate in a dialogue with the company's Global Patient Relations team, project vice presidents, medical specialists, and trial managers.
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Big Data Powers Insights For COVID-19
6/1/2020
One challenge facing the research community today: acquiring meaningful data sets on the COVID-19 pandemic. Read how technologies and workflows can be combined to provide a solution.
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The Critical Role Of Sample Tracking
6/1/2020
The value of a single sample has increased tremendously, shifting the focus of sample management from one of a maintenance procedure to a dedicated investment ensuring the integrity, organization, and safety of all samples.
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eSource: 6 Steps To Understanding
5/29/2020
There’s a lot of confusion surrounding eSource. What is it? How is it used? What’s wrong with the way I’ve been
recording my data since 2007? Here, we aim to clear the muddied waters. -
What Patients Are Telling Sites About Trial Participation During COVID-19
5/28/2020
LMC Manna conducted interviews with patients who are currently enrolled in a Phase 3 clinical trial at one of their sites, with questions focusing on the impact of COVID-19 during their trial participation. Here's what they had to say.