For research in areas such as Parkinson’s disease, digital endpoints may soon be used as primary endpoints, allowing for in-home clinical trials to be conducted over longer periods of time, says CRO.
Upperton Pharma’s new and expanded facilities received a positive inspection from MHRA, enabling both research and development and clinical manufacturing at the site.
Parexel Biotech will support emerging companies from development through commercialization with tailored services and customized guidance, says division lead.
Apptomics is working with BBK and Biotaware to develop the remote health-monitoring platform, which recently served as a digital biomarker to evaluate treatment effects as part of an essential tremor clinical trial.
The UK Government last week provided an update on the regulation of clinical trials in the event of a “no deal” Brexit, with a commitment to ensure any new requirements are not “unduly burdensome.”
Awareness around the potential opportunities created by artificial intelligence has never been higher, but pharma’s biggest challenge in 2019 will be adopting and scaling the right technology to improve patient outcomes, says an industry executive.
Most CROs are struggling with employee retention, a challenge not new to the industry, which has seen turnover levels at or above 20% for seven of the last 10 years, according to a recent report.
By Jim Kremidas, executive director, Association of Clinical Research Professionals
This time next year, I hope I can write a column with the headline “2019: The year of cooperation and communication in the clinical trial industry.” We’ve made some exciting progress toward that end in 2018. Now it’s time to take it to the next level.
The biopharma industry is on the precipice of making personalized medicine a reality with access to massive amounts of data, computing power, and artificial intelligence to run in silico clinical trials, says GNS Healthcare CEO.
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...
Clinical trials suggest that long-acting injectable antipsychotics should be expanded into a broader range of clinical settings and patient populations, says Premier Research executive.
Global regulatory agencies had a busy 2018. Here, we take a look back at some of the key developments throughout the year, as the industry navigated challenging politics, pressure to increase transparency, and the rapidly evolving digital health space.
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.
Biorasi plans to scale several aspects of its global CRO business following a PE investment – and while it does not plan to “buy size,” smaller strategic acquisitions are not out of the question, says company executive.
Smithers Avanza’s Bioanalytical Services division is adding 18,500 square feet of laboratory space in New Jersey to support the development of biotherapeutics.
Histo-Scientific Research Laboratories and Vet Path Services have merged to create one company dedicated to providing histology, pathology, and archiving services to the biopharmaceutical, medical device, and contract research industries.
The expansion collates WuXi AppTec’s technology platform small molecule capabilities, including screening, discovery biology, pharmacology, and process R&D.
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.
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.
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?
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.
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.
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.
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.
Litmus Health’s profile of the wearables market names the top 15 devices today available to researchers incorporating real-life data into studies and trials – with a focus on data quality and transparency.
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.
ABL named a successor to its previous CEO, Syneos has two new hires, and BTS Research appointed a VP to push its growth model. These, among other people on the move this month.
