Regulatory affairs

(Image: Getty/masterzphotois)

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.

(Image: Getty/	Burak Karademir)

2019: The year of women in research?

By Maggie Lynch

It’s been 25 years since the NIH Revitalization Act, yet, the industry is only now approaching parity in clinical research, says researcher.

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