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...
Research involving individuals with schizophrenia can pose unique challenges with recruitment, informed consent, clinical trial design, and the use of placebos.
Cambrex is investing $1m at its High Point, NC-based site, marking the most recent in a series of investments which will see the addition of 1,300 square feet and 15 new employees.
The owners of Synteract, Amulet Capital Partners, have acquired a global health communications and market access group with plans to merge it with Peloton Advantage, which it purchased earlier this year.
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.
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.
The new year will bring more data than the last 500 decades, information that will be used to improve clinical trial design and shorten drug development timelines, say industry experts.
The industry has a “tremendous opportunity” to build on its progress by further improving operational performance in the face of pricing and patient access challenges.
Throughout 2018 the industry worked to listen more closely to the voice of the patient, though to secure this data, it must navigate currently misunderstood GDPR requirements in the new year.
Potentially increasing costs and dropping returns from investing in innovative medicines and devices will be among the main challenges faced in 2019, says industry analyst.
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?
Access to medicines across the English Channel could be ‘significantly’ reduced for up to six months, if the UK leaves the EU without a deal, according to MP.
Clinerion and Santa Casa da Misericordia hospital are partnering to bring clinical trial opportunities to patients and diverse data to CROs and sponsors.
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.
The new “groundbreaking” model can translate the results of mouse experiments into the equivalent human condition, outperforming traditional methods of extrapolation by up to 50%, say researchers.
PPD is adding nearly 6,000 square feet of new lab space – and about 20 employees – dedicated to gene and cell therapy analytical testing at its site in Athlone, Ireland.
The digital patient recruitment and engagement company has released its new digital solutions to build long-term relationships with clients, sponsors, and CROs.
The information analytics business Elsevier has launched a new cloud-based data platform, Entellect, to de-silo, contextualize, and connect drug, target, and disease data.
Medidata’s machine learning-based solution revealed novel biomarkers for Castleman disease among other discoveries that could help accelerate diagnosis and treatment.
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.
SPARC and Schrödinger will collaborate to use Schrödinger’s technological platforms and SPARC’s insights into research therapeutics for neurodegenerative conditions.
ARG has made the move across the Atlantic, establishing its first office outside of the US following its acquisition of the UK-based CRO CCA Clinical Research.
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.
The clinical-stage gene therapy company Voyager Therapeutics has entered into collaborations with Brammer Bio and Fujifilm Diosynth Biotechnologies to expand its manufacturing capabilities.
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.
Mylan has requested all lots of valsartan, as well as combination amlodipine/valsartan, and valsartan/ hydrochlorothiazide tablets, be returned in the US.
The US FDA’s New Inspection Protocol Project represents an “improvement process step” towards a risk-based site selection model, according to the Swedish CDMO.
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.
