News

Applied Clinical Trials presents the latest issues that have risen to prominence since RBM adoption grows. This edition presents a well-rounded look at RBM including articles that describe current RBM trends; a survey of European CRAs, which shows the difficulties among sites and monitors with RBM; a comprehensive look at how sponsors and CROs can support their employees in the RBM transition, and closes with a case study on Novartis' use of adaptive monitoring.

Oncology remains the therapeutic area with the most drug failures, the lowest numbers of patients enrolled and the highest with the number of drugs in clinical trials. Many trends in oncology clinical trials seek to address these challenges and include the use of biomarkers, immunotherapies, and adaptive designs.

It is important to devote quality time to challenge yourself and your teams on whether there is a need to strategize and rethink the way you are conducting teleconferences for your clinical trials.

Translational medicine; bench-to-bedside; agile development. All these terms use updated processes, new technologies and data to inform decisions earlier in clinical development. Supported by expedited regulatory pathways, which require extensive safety monitoring to accompany these earlier approvals, has made the gaps between preclinical and clinical a looming reality.

Have the roles of the monitor advanced? How are CRAs accepting the change? How is pharma implementing RBM-is it more remote, centralized or a combination? How important is eSource to RBM? This eBook will highlight articles that answer these question.

This eBook will focus on the specific needs and concerns of the smaller to mid-size biopharmaceutical company. Articles cover considerations from Phase II to commercial pathways.

What used to be segregated approaches in clinical trials-ePRO, telemedicine, mobile health, devices and wearables-now gather under the umbrella of technologies that touch the patient. And those technologies can have positive implications for costs efficiencies in clinical trials, streamlined data collection, as well as on patient compliance and retention.

Cancer's R&D Convergence will highlight the changing landscape for clinical trials in this therapeutic area based on the promise of the Cancer MoonShot initiative, along with new oncology immunotherapies.

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?