Newsletter | March 9, 2020

03.09.20 -- Protecting Patients & Creating Competencies In Clinical Trials

 
Featured Editorial
Free-From-Harm Training: Protecting Patients And Creating Competencies In Clinical Trials
 
By Beth Harper and David Hadden

The basics of medical practice are to do no harm, and the core tenets of GCPs are to protect the rights, safety, and well-being of the trial subjects. When training doesn’t allow for practicing clinical research competencies in a safe environment, then we are in danger of violating the principles we are trying to teach.

The 5 Pillars Of Clinical Trial Material Management
By Christopher Ohms, director, supply chain, Rigel Pharmaceuticals Inc.

Ensuring that enough study drug supplies are available at study sites is a requirement of every clinical trial. This article discusses five fundamental tools and techniques for effective planning, execution, monitoring, and inventory control of clinical trial material from the manufacturing, packaging, and distribution perspectives.

Industry Insights
Increasing Patient Participation In Clinical Trials: Six Areas Of Focus
White Paper | By Steve Smith, WCG

Meaningful collaboration between patients, sites, and sponsors can yield improved clinical trial outcomes. As part of that important collaboration, we see that effective patient input has the potential to increase patient participation rates in clinical trials. Incorporating patient insights into clinical trial design and execution is the first step.

Six Strategies To Stretch Your Limited Drug Supply For Clinical Studies
White Paper | PCI Clinical Services

These clinical packaging strategies can be used to help successfully manage the supply of an expensive drug product throughout the duration of clinical testing. Without doing so, there could be costly interruptions or extended delays that would have a devastating impact on a company’s timeline to commercialization.

Enhanced Cold Chain Capabilities
Article | Thermo Fisher Scientific

Along with proficient monitoring and tracking resources, Fisher Clinical Services optimizes every level of the cold chain process to ensure the security of clinical trial supplies.

Back On Track: Data Rescue On Pediatric Rare Disease Trial
Case Study | Premier Research

A pharma company developing a drug to treat urea cycle disorder struggled with a CRO that was not effectively managing the study data. As trouble mounted, the CRO quit, stranding the project at a critical point in the development cycle. Premier Research was able to step in and successfully take over the data management and statistics portion of the trial to keep the trial on track.

Innovative Data Science And Real-World Analytics Approaches In Practice
E-Book | Cytel

With the rise in digital technologies there has been an explosion in volume and type of data sources we can obtain. However, new data sources bring inherent challenges to be overcome including lack of standardization, missing data, and variation in quality. Read how Cytel's data science and real-world evidence groups have helped clients apply advanced analytical techniques to large, complex historical or real-world data sets to improve their decision making, accelerate development pathways, and enhance their probability of success.

Sponsor
 

The 22nd Evolution Summit is the premium forum bringing leading drug development executives and solutions providers together. The Summit offers an intimate environment for a focused discussion of key new drivers shaping drug development. The one-on-one business meetings provide access to leading drug development executives within pharmaceutical companies across the United States.

Solutions
In-Canada Clinical Trial Distribution
Ropack Pharma Solutions
Commercial Packaging
Bellwyck Pharma Services
Events
Medical Affairs And Scientific Communications Forum

March 23 to 25, 2020 | Anaheim, CA

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