Regulatory affairs

Rho’s new business segment aims to streamline regulatory approval

11-Dec-2018 By Maggie Lynch

Rho will expand its services with the addition of its Regulatory Strategy and Submissions business segment.

Infographic: Women in clinical research through the years

11-Dec-2018 By Maggie Lynch

Women have seen deficits and gains in their attempts to be included in clinical research, but as 2019 approaches equality seems forthcoming.

The biggest paradigm shift in decades? ICH E6 R2

11-Dec-2018 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.

2019: The year of women in research?

11-Dec-2018 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.

Parexel and Eli Lilly team up to develop clinical researcher pool in China

10-Dec-2018 By Melissa Fassbender

Parexel and Eli Lilly are launching a clinical research learning and development program in China as recent reforms have “dramatically” increased the need for new sites in the country.

Evotec and LEO Pharma partner for hit identification platform use

06-Dec-2018 By Maggie Lynch

Evotec to use its hit identification platform in LEO Pharma alliance, another drug discovery partnership among the many.

‘Patients will lose’ if airlines refuse to transport lab animals: NABR files complaint

06-Dec-2018 By Melissa Fassbender

A lobby group has filed a complaint alleging illegal discrimination by airlines refusing to transport lab animals – a battle that will be difficult to win, says an industry expert.

How the industry is addressing the ethical concerns of incorporating big data into health care

05-Dec-2018 By Melissa Fassbender

In the era of big data, the industry is working to address the ethical concerns of integrating patient information into the health care landscape – though a key challenge will be reaching a consensus on what constitutes reliable evidence.

Guest column

To access the rewards of big data in health care, potential risks must be managed

05-Dec-2018 By Melanie Brickman Borchard, PhD, MSc, director of life sciences, New York Academy of Sciences

Increased access to real-world data sources opens up new possibilities, but it also raises new ethical questions, which cannot be tackled by one organization, government agency, or company alone.

FDA’s MyStudies release is a ‘major milestone’ with ‘profound’ implications, says Iqvia

04-Dec-2018 By Melissa Fassbender

The FDA recently released open source code and technical documents for its new mobile app – MyStudies – which is designed to collect information about medication use, health system touchpoints, and patient-reported outcomes.

Number of South Korean biotech sites increased by 12% last year: Novotech

03-Dec-2018 By Melissa Fassbender

The Asia-Pacific CRO Novotech has grown its operations in South Korea, a market that has seen greater interest from North American and European companies, says exec.

Janssen: ‘There’s too much at stake to settle for doing things the way we’ve always done them’

28-Nov-2018 By Melissa Fassbender

The industry must be “relentless” in driving the adoption of new advances in technology, says Janssen, which has shifted from doing things for patients and investigators, to doing things with them.

Canada-based CRO Biopharma Services passes WHO inspection

27-Nov-2018 By Maggie Lynch

WHO recently assessed Biopharma Services, which demonstrated compliance across multiple regulatory and organizational guidelines – opening the doors to conduct more work with the WHO foundations.

World Courier making multi-million dollar tech investment

21-Nov-2018 By Maggie Lynch

World Courier has made a multimillion-dollar investment in its supply chain technology to help meet the expanding needs of the pharmaceutical industry.

PHARMA INTEGRATES

Limiting health care data collection is a bogus, fake conversation, says Health iQ exec

21-Nov-2018 By Flora Southey

Rather than limit health care data collection, the industry should focus on ensuring those data sets are used ‘in the most appropriate way,’ according to Health iQ chief commercial officer.