Watson for Clinical Trial Matching has shown an 80% increase in clinical trial enrollment at Mayo Clinic, which is expanding its partnership with IBM to further develop the cognitive computing platform.
Novartis hopes to eventually recruit ‘a significant portion’ of patients into a decentralized clinical trial model that has the potential to increase the company’s reach globally, says exec.
Novartis is expanding its strategic alliance with Science 37 and has committed to conducting up to 10 new clinical trials – blending both virtual and traditional models – over the next three years.
With fewer global mid-sized contract research organizations (CRO) through consolidation, some stakeholders are expressing concern that the industry could become a monopoly – “we may be getting there,” one expert said.
Tax policy reforms have made the US and UK attractive locations for drugmaker investment, says PwC’s Jean Delaney, but argued Ireland is “still well positioned on the tax front.”
In an open letter to the US Food and Drug Administration (FDA) AllTrials implores the agency to fine clinical trial sponsors that don’t publish trial results on ClinicalTrials.gov – as no fines have been issued to date.
Scientist.com is working to implement an improved contractual landscape ahead of GDPR implementation in May, in order to ensure global compliance among sponsors and CROs.
The Republic of Ireland will move its population from short-acting to extended half-life haemophilia therapies, under an exclusive two-year deal with Sobi.
CTTI has completed more than 25 projects on issues affecting clinical trials over the past decade, since which time the industry has changed greatly, says executive director.
IQVIA has been contracted to expand the safety and efficacy monitoring of biologic products as part of a novel alliance with the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER).
The EMA’s decision to release clinical trial documents requested in accordance with its Transparency Regulation has been upheld in court after companies filed to suspend the release in 2016.
Advarra has selected TransPerfect Life Sciences as its strategic supplier of language services, including document translation, digital content localization, and interpretation services.
CTI Clinical Trial and Consulting Services (CTI) has opened a new office in Singapore – a location that will enable the CRO to attract and retain talent as it continues expansion in Asia.
Apple has updated its Health app to give users access to their medical records – a new feature that could fundamentally change the way research is conducted, says Medidata.
Semler Research Center says the US FDA caused the “complete annihilation” of its business after regulators rejected bioanalytical studies on the back of data integrity concerns.
The US FDA has asked Braeburn Pharmaceuticals for more information regarding its sustained-release subcutaneous buprenorphine injection in a complete response letter (CRL).
The US Food and Drug Administration (FDA) is launching a new pilot program this month aimed at increasing clinical trial transparency – though many opportunities remain to improve the scope, clarity, and usability of data, says TrialScope CSO.
Revisions to the Federal Policy for the Protection of Human Subjects has been delayed six months, possibly more, as regulators cite the rule’s complexity, lack of guidance, and other challenges.
The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) recently established a new advisory council devoted to patient engagement.
Recent changes in legislation are likely to increase the presence of foreign CMOs in China, says newly formed fill/finish firm Wuxi Griffin Pharmaceutical.
INC Research/inVentiv Health is starting the new year with a rebrand after merging to create one of the largest biopharmaceutical outsourcing providers in 2017.
The Patient Engagement Collaborative will include 16 patients, caregivers, and patient group representatives who will provide “a collective, all-encompassing patient voice,” says CTTI project manager.
The Good Pharma Scorecard aims to quantify what makes a “good” pharmaceutical company – as 91% of Americans think companies put money before people, says Bioethics International founder.
Aurobindo Pharma Limited has denied rumours it is interested in Orchid Pharma after a report suggested it is vying with Dr Reddy’s to acquire the bankrupt API firm.
Advertising, social media and individualised patient recruitment strategies can improve participation numbers according to clinical site executives, who say they favour a personalised approach.
Parexel has launched its first offering as part of its alliance with Microsoft, through which the companies are looking to redefine the life sciences industry, says CRO.
By Sudip S. Parikh, PhD, senior vice president & managing director, DIA Americas
The healthcare product development ecosystem is undergoing massive changes. Significant transformations are underway in how drugs and medical devices are researched, developed, manufactured, and approved.
Identifying dangerous medicines will take months longer if the UK cannot negotiate continued involvement in EU drug safety and health monitoring say industry groups.
CTI Clinical Trial and Consulting Services (CTI) and Eurotrials have consolidated to create a full-service contract research organization (CRO) with a global footprint.
Science 37 and Otsuka Pharmaceutical have announced a strategic collaboration through which the global healthcare company aims to explore patient-centric clinical trials – “with fewer physical restrictions and greater efficiencies,” says CEO.
UK regulators have issued Bangladesh-based drug maker The Acme Laboratories Limited a statement of GMP non-compliance after finding a plant inspection.
The US Food and Drug Administration (FDA) has released a new draft guidance as part of its stated commitment to assist sponsors and expedite drug development for rare pediatric diseases.
