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Biopharma
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From Reactive to Predictive: The Unseen Architecture of Modern Risk Management
How Clinical Teams Are Replacing Firefighting With Future-Proof Monitoring
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5 Keys to Successful Partnerships: Building Stronger Collaborations to Support Medtech and Pharma
Successful business partnerships within the life sciences industry are often the cornerstone of thriving drug development. Here are five essential...
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Risk Management in Pharmacovigilance
It’s important to know that whenever a new medicinal product is authorized based on specified indications at the time of authorization, the benefits...
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Meet the Team: Danita Harris, SVP and General Manager of Data Management and Analytics
In this installment of our “Meet the Team” blog series, we talk to Danita Harris, Senior Vice President and General Manager of Data Management and...
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Meet the Team: Sakthivel Sivam, Senior Director, Biostatistics
In this installment of our “Meet the Team” blog series, we talk to Sakthivel Sivam, Senior Director, Biostatistics, about his industry experience,...
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Meet the Team: Aarekh Shrestha, Senior Manager, Drug Safety and Device Vigilance
In this installment of our “Meet the Team” blog series, we talk to Aarekh Shrestha, Senior Manager, Drug Safety and Device Vigilance,...
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Basics of Drug Safety: Importance of Case Processing in Pharmacovigilance (PV)
Case processing in pharmacovigilance is a fundamental activity to support safety surveillance in clinical trials. Along with an anticipated...
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A Data Management Perspective: How Are Device Trials Different from Drug Trials?
Many articles discussing the difference between drug and device trials come from a regulatory perspective on how clinical trials are designed and...
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Meeting Early Phase Study Challenges – a Data Management Perspective
First-in-Human studies are a discovery point, which can decide the fate of a compound as well as lay the groundwork for subsequent phases of a...