Regulatory affairs

WuXi and I-Mab extend partnership to accelerate biologic development

18-Apr-2019 By Maggie Lynch

I-Mab and WuXi Biologics extend their strategic partnership for biologics process development as well as clinical and commercial manufacturing to accelerate drug development in China and abroad.

Clinical research is a 'dance you learn as you go': ACRP 2019

18-Apr-2019 By Maggie Lynch

Live updates from the leaders and speakers of the clinical research industry this past week in Nashville, TN, as they discuss the past, present, and future of clinical research as it continues to grow, evolve, and become patient-centric.

All-digital clinical trial demonstrates the feasibility of siteless studies

17-Apr-2019 By Maggie Lynch

Virtual trials are poised to scale, says the CEO of Transparency Life Sciences, which recently conducted a siteless study to assess the feasibility and ease of collecting research-grade clinical data from subjects remotely.

CROs comment on FDA's new draft guidance for conducting natural history studies

16-Apr-2019 By Melissa Fassbender

Natural history studies provide researchers with a better understanding of a disease’s progression, supporting clinical trial design, among other benefits, say industry experts commenting on the FDA’s new draft guidance.

FDA’s project uses RWE to estimate trial results

15-Apr-2019 By Maggie Lynch

The FDA is advancing its project designed to determine the scientific validity and regulatory application of real-world evidence.

Pfizer partnership uses RWD to advance precision oncology

11-Apr-2019 By Maggie Lynch

Pfizer collaborates with Concerto HealthAI to advance precision oncology through the use of real world data.

WCG targets pain management, opioid alternatives in Analgesic Solutions deal

08-Apr-2019 By Maggie Lynch

WCG acquires Analgesic Solutions for advisement on protocol design and the development of clinical trials in which pain is an indicator of an underlying condition.

BMS taps Concerto HealthAI to bolster protocol design

08-Apr-2019 By Maggie Lynch

Bristol-Myers Squibb enters a multi-year strategic agreement with Concerto HealthAI to use machine learning to aid in protocol design for precision treatment and improved patient outcomes.

#TrialChat

An evolving discussion: ‘Clinical trial awareness cannot happen without all of us’

02-Apr-2019 By Melissa Fassbender

The discussion surrounding clinical trial awareness has evolved “from mere conversations to action, creativity, and inclusivity from multiple stakeholders,” and will continue to evolve as we work together to create a paradigm shift in awareness, says...

FDA offers further RBM guidance stressing data quality oversight

02-Apr-2019 By Melissa Fassbender

Since finalizing its risk-based monitoring guidance in 2013, the FDA is providing additional information in a new Q&A that reinforces the importance of performing risk assessments for all studies.

CROs ink exclusive partnership ‘to rapidly advance the field of otic research’

01-Apr-2019 By Melissa Fassbender

Sinclair Research and Turner Scientific sign an exclusive partnership through which the CROs will offer ototoxicity testing services – and improve regulatory guidance regarding the ears to protect patients, says company executive.

New consultancy targets ‘expansive global landscape’ for cell and gene therapies

01-Apr-2019 By Melissa Fassbender

Cell One Partners formally launches its consulting services and aims to be a long-term partner to its clients, supporting the development of cell and gene therapies – a market which raised more than $13.3bn in 2018.

People on the Move: Outsourcing-Pharma roundup March ‘19

29-Mar-2019 By Melissa Fassbender

The industry in March saw new c-suite appointments at CRF Bracket, PCI Pharma Services, George Clinical, and Paragon Bioservices – as well as moves to boost medical device and DMPK services at Premier Research and Sygnature Discovery, respectively.

Trialbee and Linical partner for patient-centric trial recruitment

28-Mar-2019 By Maggie Lynch

Trialbee and Linical Accelovance join forces for patient-centric clinical trials using digital innovations to establish a single point of contact to expedite clinical trial enrollment, retention, and speed-to-market solutions.

‘The UK may no longer be a country where bioanalytical innovation is feasible,’ says CRO on Brexit

28-Mar-2019 By Melissa Fassbender

Clinical trials in the UK are reportedly declining as the country grapples with Brexit – a change which could make access to preclinical and bioanalytical research materials, including NHPs, problematic, says QPS.