Data management

(Image: RamCreativ)

Infographic: Unifying clinical operations

By Melissa Fassbender

CROs are taking steps to improve study start-up as collaboration with sites and sponsors continues to be a challenge, one which a unified clinical operations model aims to address.

(Image: Getty/Sarinyapinngam)

Guest Column

Collaboration created the cornerstone of better clinical trials – now, it’s time to build

By Pamela Tenaerts, executive director, Clinical Trials Transformation Initiative (CTTI)

We entered 2018 with a solid foundation in place for building better, more efficient clinical trials. Throughout the year, progress – particularly in the areas of mobile technologies, real-world evidence, and patient engagement – resulted in new, tangible...

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The biggest paradigm shift in decades? ICH E6 R2

By Melissa Fassbender

ICH E6 R2 sparked a paradigm shift, though 2019 will see the clinical trials industry transition from a risk-based monitoring approach to risk-based quality management.