This special report offers an article regarding current FDA thinking and future direction with these assessments. ERT-a cloud platform solutions provider that captures quality efficacy and safety endpoints in centralized Cardiac Safety, Respiratory, Suicide Risk Assessment, and Clinical Outcome Assessments-offers expert view on this regulatory change.
Clinical trials have increased in number and complexity for numerous reasons-global trials, outsourcing, protocol requirements, and multiple regulatory issues. Factor this with the increased need to bring efficiencies and lower prices to the clinical trial process, and the need to stay on top of trials only becomes more crucial. This eBook will include articles on logistics of clinical trials supplies, negotiating with investigative sites, use of e-signatures and more.
In this article, Moe Alsumidaie will discuss QA updates.
European Union faces a critical view on its pediatric drug development situation, highlighting a lack of treatment, infrastructure, reimbursement, and regulatory agreement.
New FDA guidances outlining recommended approaches for clinical testing methods and collecting research data, alongside with public workshops and meetings, accelerate reviews to speed new therapies to market.
Examining the barriers, challenges, and outcomes to determine the effectiveness of different RBM implementation approaches.
New study reveals that inconsistent, tactical, and reactive outsourcing practices predominate.
Click the title above to open the Applied Clinical Trials December 2018 issue in an interactive PDF format.
Outlining the potential of three mHealth technology approaches in enabling novel and more robust clinical outcomes measurements.
The availability of FHIR-based APIs enabling patients to access and use their healthcare data for multiple purposes has opened a door to an entirely new world of opportunities for partnering with patients on clinical studies.
Have you seen many paradigm shifts lately?
Survey highlights thoughts on digital integration, managing data sources.
Survey uncovers key findings amid today’s explosion of data volume and sources-and the added complexity in managing clinical data.
In this interview, Carolyn Brehm, BMS Study Connect Business Lead, will discuss how BMS is helping to match patients with studies through Study Connect.
The exponential growth in the use of Direct-to-Patient clinical trials and the strategies pharmaceutical manufacturers should consider when implementing this model.
The decision of the leaders of the European Union over the weekend to endorse the Withdrawal Agreement for the UK's departure was historic in that it was the first time ever that the European Council had to face the imminent reality of a member state dropping out.
The rapid rise of targeted drugs and biologics in oncology has spurred sponsors and the FDA to innovate, leading to the creation of a variation to the typical trial design that can include multiple expansion cohorts.
The core tenets of blockchain technology-a decentralized and encrypted way of distributing, sharing, and storing information-seem appealing for health data.
According to the IQVIA Institute for Human Data Science, the pharmaceutical industry loses roughly $35 billion annually as a result of temperature excursions, making transport one of the weakest links in many manufacturers’ supply chains.