Newsletter | October 12, 2020

10.12.20 -- Bayer Overhauls Its Clinical Trial Planning Process

 
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Embrace Quality Risk Management To Build A Strong Quality Culture

Using quality risk management (QRM) gives a company the ability to maintain compliance while also identifying product issues that could be harmful to the consumers, some being susceptible patients.

Real-World Data In Times Of Change

The COVID-19 experience has laid bare the inefficiencies in U.S. and global healthcare systems. We need innovation. Innovation is about transformation and having the courage to change what isn’t working. Our ability to provide effective solutions depends on the availability of relevant data to drive this change. Our future may yet rest in our ability to unlock real-world data (RWD)-driven insights faster in pursuit of better care and more effective cures.

Remote Investigator Meetings Another Piece Of The Virtual Trial Puzzle

One key milestone at the start of a study is the investigator meeting, where, in some cases, well over 100 professionals may gather from various locations. Since, as a community, we are actively in the process of exploring where we can and cannot go remote, investigator meetings are a perfect example of where there is great potential.

A Multipronged And Customized Approach To Rare Disease Clinical Trial Patient Identification And Recruitment

Research and development investment in rare disease treatments continues to grow and challenges remain in the global identification and recruitment of eligible patients for specific indications with a low disease prevalence. Leveraging precision medicine, data-driven solutions, and collaboration across the rare disease community are instrumental when developing a customized strategy for patient identification and recruitment.

What Your Clinical Study Design Reveals About Your Clinical Packaging Needs

Securing a stable supply chain to deal with the uncertainties of clinical trials is critical. One misstep can have a profound impact not only on the cost and time of your trial but also on its overall success. To ensure the timely delivery of the necessary supplies a sponsor must have a strong clinical packaging strategy that takes into account the most important details of its clinical study design.

Oncology CRO Oversight FSP

To ensure compliance with the updated ICH E6 (R2) guidelines, and to address internal capacity issues, a midsize biopharmaceutical sponsor required qualified support to help ensure appropriate oversight of several large, global CRO providers. By embedding an oversight team within the sponsor’s team Catalyst was able to alleviate a backlog of activities, while providing effective CRO oversight.

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EDC Transformation Meet Today's Clinical Trial Needs
 

When electronic data capture (EDC) in clinical trials began, almost 30 years ago, it was revolutionary to clinical research. Since then, advances in science and technology are forcing the industry to consider new methods for collecting and using clinical trial data. The initial EDC systems were not designed to store and manage the influx of clinical data we are seeing today, and, frankly, will not be able to support trials in the future. Further, the current global environment is shining a spotlight on antiquated systems and processes and is compelling the industry to rapidly embrace new ways of approaching clinical development, and specifically data collection.