All news articles for December 2018

(Image: Getty/SARINYAPINNGAM)

A year in review: A perspective from the Society for Clinical Research Sites

By Jessica Knott, senior communications manager, Society for Clinical Research Sites

The Society for Clinical Research Sites builds its focus and programming around improving site sustainability. However, a troubling and ever-present factor within the clinical research industry is that, by and large, many of the problems facing the site...

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Q&A

2018: An inflection point for generics

By Flora Southey

Generics drug portfolios are diversifying, prices are stabilising, and while competition remains intense, the worst of price erosion appears to be over, claims Clarivate Analytics executive.

(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/Светлана Зайцева)

US farm bill a boon for pharma?

By Flora Southey

If approved by President Trump, the five-year farm bill – which removes hemp from the federal controlled substance list – could help advance cannabinoid R&D, says Nexien Biopharma.

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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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Boehringer reshuffle cuts 327 jobs in France

By Flora Southey

Boehringer says it will reduce its workforce in France, including 182 positions in human health, to streamline operations in ‘deteriorating markets’.

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Guest column

M&A in the CRO industry: The Good, The Bad, and The Ugly

By Matthew Barrows, senior business consultant

M&A is a huge part of the CRO space. Inorganic growth has long been the go-to strategy for any CRO and we’re never surprised to see this month’s latest deal. However, I’d like to challenge the idea that this is always the best way to grow a CRO business.

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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.

(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.

(Image: Getty/kishore kumar)

5 predictions for AI in 2019

By Melissa Fassbender

While several companies touted the potential of AI to disrupt the drug development industry in 2018, what practical applications can the industry expect next year?