The European Reference Networks aims to join the efforts of the best specialists in Europe to tackle complex or rare medical conditions. The goal is to create networks covering a specific disease with an emphasis on procedures or techniques related to treatment.
Months of rumblings across Europe that the scheme to promote orphan drugs is being abused by drug firms to maximize profit instead of innovation have been heard. Those rumblings have now turned into shouts.
The FDA’s breakthrough drug initiative is accelerating clinical development of new therapies. A recent analysis found that pre-market development time for breakthrough-designated drugs is 2.2 years shorter than for those without the designation.
Mike Graziano, VP of Toxicology at Bristol-Myers Squibb, sits down with Moe Alsumidaie to discuss BioCelerate’s toxicology data sharing initiative.
The Geriatric Medicines Working Party of the EFGCP is organizing a workshop on “Technology, Ethics and Older People in Clinical Research.” The goal is to explore what can be done to involve older people in clinical trials.
RBM and changes in quality management are impacting study teams, CRAs and sites.
Over the last 30 years, the process of clinical research and clinical trials have undergone a revolution. However, despite these changes investigator meetings have not evolved.
New policy hopes to calm the fervor around clinical trial data disclosure and confidentiality issues.
Worldwide Clinical Trials recently announced the results of a survey that evaluated the perceptions of clinical trial site investigators who use electronic clinical outcome assessment (eCOA) technologies.
This article focuses on the 3 essential factors that have a significant impact on the outcome of any inspection or audit. The author applies this primarily to GCP (Good Clinical Practice) inspections, but the principles are universal, being applicable to any government inspection such as the FDA (U.S. Food & Drug Administration) or industry QA (Quality Assurance) audit.
Valeant is a hedge fund disguised as pharmaceutical company, with the moral at the end of it's story, poor ethics leads to collapse.
Pharmacists have new prominence in a new European system, created jointly with drugmakers and wholesalers and parallel traders, that will provide on-line identity-checks on each individual medicine from factory to pharmacy.
Lagging indicators and superficial averages are increasingly replaced by sophisticated performance metrics and predictive analytics harnessing the power of big and small data.
With the introduction centralized monitoring in a risk-based monitoring (RBM) approach, the central monitor is emerging as a key and important role.
Ambry Genetics' CEO discusses his company's decision to release the genetic information of its customers for free - a rare move, reportedly, for a commercial testing firm.
Use the “CLEAR ” path to effectively engage patients and build their confidence in an increasingly digital and mobile pharmaceutical environment.
Good clinical trial risk management involves good protocol design and study operational design at the sites.
Hans-Georg Eichler, the Senior Medical Officer at the European Medicines Agency, addresses adaptive pathways as a way to "ensure sustainability of the innovation system and the healthcare systems."
This week, The Netherlands, which is in charge of EU business for the first six months of this year, has convoked an intensive round of meetings to show that it really is taking health policy seriously during its turn in the rotating EU presidency.
European health officials and patient advocates speak bluntly on the treatment access dilemmas for patients with rare diseases-and point to opportunities in translational research and joint negotiations with manufacturers as possible solutions to close gap.
The data analysis in this article will delve into Clinical SCORE’s normative database to generate predictive models, and qualitatively reason the findings.
On Wednesday, DrugDev is debuting its Site Activation Module at the SCOPE Summit. The company believes the module will greatly improve all tasks of site activation, from protocol feasibility, site identification and selection, to contracts and the collection of site regulatory documents.
Reactive, hastily enforced regulations can easily jeopardize the sound conduct of a clinical trial and its data flow, potentially threatening both subject safety and data quality.
With the initial promise of immunotherapy use in oncology, we need to continue supporting cross-industry collaborations among leaders from the biopharma community, academia, regulators, and private sector investors.
Slightly more than a thousand healthcare research projects were funded by the European Union between 2007 and 2013, at a cost of $6 billion, revealed Carlos Moedas, European Commissioner for Research, Science and Innovation, at the end of January.
Incoherencies in Europe’s drug-access arrangements raise questions, debate.
mHealth is making a strong case for its ability to optimize clinical trials and improve engagement with participants and patients.
When paying and reimbursing clinical research volunteers for study participation, what can be done to make the experience more patient centric?
Telling signs from U.S., Russia, Latin America and UK indicate that governments are squeezing as much value as possible out of their spending on pills and procedures.
As in other needs in the clinical trials chain, endpoint adjudication is an area that can be greatly improved by technology.
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