Newsletter | December 2, 2020

12.02.20 -- Post COVID-19: Clinical Trials Will Never Be The Same

 
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Industry Insights
Making Clinical Trials More Effective By Keeping Focus On The Patient

The need for clinical trials to meet the requirements of regulators, deliver high-quality data, and come in on budget has led to study designs that focus on timeliness and convenience, yet may unduly burden and inconvenience patients. Today, priorities are changing as sponsors realize studies designed around the needs of patients also result in benefits to other stakeholders. This has led to the rise of patient-centric clinical trials.

Redefining Clinical Strategy With Scenario Planning

Many facets of a clinical trial are unpredictable. Patient enrollment, a critical and often troublesome step, can vary widely within regions, countries, and sites, as well as across therapeutic areas. This unpredictability increases the complexity of clinical trial planning. This is why scenario planning is so valuable and critical in helping to manage the variability in clinical trial setup decisions.

Local Lab Normalization

Local laboratory data normalization is a routine process in clinical trial data management. However, even with standardized collection and transport procedures across the laboratories, there is often variability to account for. This paper highlights the modern need for access to local laboratory data in near real time.

The Evolution Of The Modern Medical Monitor

There is an opportunity for medical monitors to redefine their role in a new era of tech-enabled, productivity-focused digital data analysis. In this white paper, we’ll explain what distinguishes this emerging role from its more traditional predecessor, and we’ll leave you with a keen sense of how to identify, hire, and empower a modern medical monitor to help your next study proceed toward submission more productively, and with greater data integrity, than ever before.

Respiration Rate Measurement With Philips Health Band In Adults With Life-Style-Related Chronic Disease

The Philips Health Band (PHB) is a wrist-worn wearable device that leverages accelerometry and photoplethysmography (PPG) sensors to deliver sleep, cardiology, respiratory, and energy expenditure (EE) endpoints. In this study, the respiration rate was evaluated for accuracy and performance in adults with (or at risk) for life style-related chronic disease using the Philips Health Band.

How A Best-Practice Strategy For Sourcing Ancillary Materials Reduced Risk, Spending, And Workload In A Global Diabetes Trial

It’s impossible to run a global clinical trial of an investigational diabetes drug without ancillary materials. And, as one leading multinational pharmaceutical company recently learned, managing ancillaries can be a challenge every bit as complex as the trial itself.

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January 26 to 28, 2021 | 9:45 a.m. to 5:00 p.m.

 

DIA's Pharmacovigilance and Risk Management Strategies Conference provides the foundation for strong strategic planning and practical decision-making in pharmacovigilance programs. Developed by recognized experts from the biopharmaceutical industry and global regulatory agencies, this conference provides the background, context, and opportunities to discuss current challenges and to problem solve around issues that matter most to professionals working in the field.

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