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 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 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.
Iqvia describes the new platform as the marriage of eConsent with an authoring system – giving the clinical trial a framework for transparency and transformational change.
The pharmaceutical industry has increasingly been adopting artificial intelligence – which has demonstrated the ability to predict instances of schizophrenia with 74% accuracy.
The health care social network Inspire is expanding its research solutions to help life science stakeholders integrate the patient voice and experience into research.
Data Cubed’s new CCO David Kiger – who has held roles at Bioclinica and Parexel – says the company is primed to be the go-to provider as the industry continues to shift to virtual clinical trials.
Advanced Clinical is partnering with Cognitive Clinical Trials to overcome recruitment road blocks in Alzheimer’s clinical trials and expedite research through patient centric model.
A consumer rights watchdog is calling on regulators to suspend research at a Minnesota-based medical facility in response to concerns surrounding informed consent for a study involving Ketamine.
The online resource organizes and maps myriad sources of research on clinical trial recruitment to help users identify promising interventions, say report authors.
Hu-manity.co is taking on the human data marketplace with its mission to establish a 31st Human Right: Legal ownership of human data as property – a shift that could help improve clinical research and increase transparency, to begin.
Genetic testing could potentially transform the way clinical trials are conducted – but for the patient, the role of the genetic counselor is a key component of this process.
The EMA has revealed that it is having to cope with “significant staff losses” due to Brexit, which means that it will have to temporarily cut certain activities.
It has been nearly 20 years since a currently available drug was tested and approved specifically for the newborn population, say industry experts who are calling for education and policy changes to address the needs of this special patient population.
Bayer AG and Elsevier studied more than 1.6m adverse events to show how big data can be used to reduce animal testing and design trials "altered to potential risks," says researcher.
President Trump says he will sign the “big legislation” after the US House of Representatives passed the Right to Try Act – opponents of which warn lacks key patient protections.
Glenmark Pharmaceuticals has suspended a Phase II clinical trial at a site in India following media reports that villagers were allegedly “deceived” into participating.
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).
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.
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.
WIRB Copernicus Group (WCG) has expanded its portfolio of companies to include the pharmacovigilance and drug safety solution provider Vigilare International.
As the industry continues to externalize components of the supply chain, global regulatory authorities are requiring a “quality-by-design” (QbD) approach to help mitigate risk across the drug development process.
ICON and the International Consortium for Health Outcomes Measurement's (ICHOM) pilot patient outcomes platform – known as ‘Globe’ – aims to improve drug development procedures.
Clinical trial participants often misunderstand the differences between research and clinical care – a ‘longstanding problem’ that an enhanced informed consent process could diminish, says report.
Citing safety concerns, drug industry stakeholders and public health organizations are urging lawmakers to uphold FDA oversight and enforcement of the 2013 Drug Quality and Security Act (DQSA).
The pharmaceutical industry and regulators are preparing for Brexit and how to best “manage and mitigate” any potential risks the UK’s departure from the EU may pose.
Enhanced clinical trial design legislation proposes an alternative to the Right to Try Act – both of which address the FDA's current compassionate use program.
Celerion has implemented Verified Clinical Trials’ (VCT) biometric fingerprint technology to address “significant amount” of participants dual enrolling at Ph I units.
The Trump administration is looking to massively reduce regulations – which could have major implications for pending guidelines that look to increase clinical trial patient safety.
The HHS issued a final rule updating outdated regulations to provide enhanced protection for clinical research participants – and the FDA may follow suit.
As holidays shoppers wrap up their presents with ribbons and bows, Outsourcing-Pharma.com reviews how contract pharmaceutical packaging companies help ensure successful patient outcomes with iterative design.
Teleflex Medical Corp. has recalled devices used to deliver rescue therapies to people who have overdosed on opioids, following complaints of mechanism failure leading to a "public health crisis".
According to a recent study, traditional efficacy trials have limited applicability in everyday clinical practice – an issue which researchers say needs to be amended.
As regulators push the industry to adopt adaptive studies to reduce risk to both patients and manufacturers, the FDA has finalized a guidance outlining key issues and recommendations.
The FDA has placed on clinical hold on Juno’s Ph II clinical trial of JCAR015 following the death of two patients last week and will “continue to work” to ensure patient safety, says representative.
