Regulatory Affairs White Papers & Case Studies
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Development Of A Ki-67 Expressing Cell Mimic For Assay Validation
12/19/2023
In order to address a clinical trial service provider's need for readily available Ki-67 cellular controls, a lymphocyte mimic expressing Ki-67 has been produced to meet the companies specific needs.
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Measuring The Energy Of One Of The USA's Most Powerful Lasers
12/1/2023
Discover how the right laser measurement solutions have helped a leading research center, working on one of the most powerful lasers in the US, overcome various measurement challenges.
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The AMI Water Meter That Modernized Madison County
11/9/2022
Explore how Madison County, challenged by increased demand, a growing customer base, and a system that was administered by the city, decided it was time to transition to an AMI water meter solution.
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Proactive Strategies For Meeting NDA Timelines Despite Last-Minute Supplemental Study Requests
3/18/2022
With just months left until planned submission of a new drug application (NDA), the Food and Drug Administration mandated a series of unexpected supplemental studies for a new oncology drug. Find out the results in this case study.
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Early Phase Rescue Study In A Progressive Rare Disease: A Personal Approach
4/20/2022
A biotech company needed a CRO to take over a Phase I single center, inpatient study for a progressive rare disease for a drug with an unknown safety profile. Discover how a thoughtful and strategic plan from recruitment through participation was developed.
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Localized Attention On A Global Scale: A Phase III Study In Early Alzheimer’s Disease
10/19/2022
In a recent Phase III study focusing on mild cognitive impairment (MCI) and mild Alzheimer’s disease, discover how recruitment was completed within 22 months, randomizing more than 1,800 subjects after screening more than 6,000 patients.
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From Lab-Scale To Tox-Batch: A Novel Vascular Calcification Inhibitor API
2/2/2023
A leading pharma company developed a small molecule drug candidate to treat vascular calcification disorders using an 8-step synthetic process. Explore the chemical development for non-GMP and GMP manufacturing.
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Point, Click, Credit: Web-Based Operations And Maintenance Training
12/21/2022
In a world of Web surfing, e-mail, personal digital assistants, and various other modes of digital communication, the advantages of providing information digitally have become obvious. For water quality professionals, the challenge is to provide an online learning environment that is readily accepted and used by staff.
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How Medable Increased Oncology Safety Monitoring By 90x
9/14/2022
Oncology trials placed a heavy burden on patients due to travel burden, poor patient experience and multi-year clinical trial commitments. Sites also struggle with cancer trials due to enrollment delays, complex data workflows, and multiple amendments requiring re-consents. Today, there is a more effective, patient-first solution.
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Fujirebio Increases Study Agility By Streamlining Clinical Operations And Data Management Process
3/2/2022
Fujirebio’s fast-growing U.S. Clinical R&D team was preparing for shorter studies with higher complexity. Traditional methods using paper and spreadsheet trackers were no longer adequate to meet quality goals. Learn how the group increased its agility and readiness with LifeSphere Clinical EDC and CTMS tools.