Peer-Reviewed Articles
The Enrollment Rescue Dilemma: How Sponsors and Sites Can Make the Most of a Tough Situation
Survey uncovers key best practices that sponsors, CROs, and sites should consider when faced with patient enrollment challenges.
The PUEKS Project: Process Innovation in Clinical Trial Monitoring
By María Proupín-Pérez, PhD, Matthias Fehlinger, PhD, Artem Andrianov, PhD, Johanna Schenk, MD, Martin Koch
A look at the results of the recently completed project, which aimed to develop an holistic monitoring system via process integration to more effectively control clinical trial risks beyond isolated RBM strategies.
Layperson Summary in the EU: Analysis of the Debate and Personal Remarks
By M. Zaninelli, E. Ornago, E. Sala, PhD, A. Ferrari, MD, PhD
Outlining considerations on layperson summary writing of clinical trial results in Europe, and proposing a "reader-centered" approach to constructing these summaries.
Comply with ICH E6 (R2)
The ICH E6 (R2) GCP Guideline became final in November 2016. As noted in the Guideline, since the original ICH E6 (R1) was released, clinical trials were performed in a largely paper-based process. E6 (R2) was developed to address the increased scale, complexity, and cost of clinical trials, and to include the advances that have been made in electronic data recording and reporting technologies, as well as the implementation of other approaches and, in fact, encourages the implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results.
The articles can help ensure your GCP is up to par in the areas included in the ICH E6 (R2).
Data Analysis
Pinpointing Phase III Trials in Emerging Countries
Most clinical trial activity for Phase III trials takes place in the traditional North American and European markets.
How Important is Big Data?
Survey collects thoughts from industry professionals on the current and future impact of big data in clinical trials.
Measuring the Added Time of Complicated Phase III Studies
This analysis uses a large dataset to forecast the study completion time costs of specific protocol designs and execution plans.
ACT TV
Events
Rare Diseases & Orphan Products Breakthrough Summit
October 16 - 17, 2017
Washington Marriott Wardman Park, Washington, D.C.
Rare Diseases & Orphan Products Breakthrough Summit
October 16 - 17, 2017
Washington Marriott Wardman Park, Washington, D.C.
Blogs
Pharma Roundtable: Breaking Barriers to Using Mobile Technology on Clinical Trials
By Jeff Lee
Jeff Lee had the opportunity to be a moderator at the Mobile in Clinical Trials event where he sat down with mobile experts within the pharmaceutical industry. The session allowed for new observations in regards to the value that these mobile technologies have within clinical trials.
FDA and Industry Move on mHealth Guidance
Austin Speier, VP of Emerging Technologies at Precision for Medicine, recently spoke about mHealth regulatory pathways at PanAgora’s Mobile Innovations Summit, and will elaborate further in this Q&A interview.
Supporting Marketing Authorization Applications with Non-Clinical Overviews
With the ever changing regulatory landscape, outsourcing non-core activities is a flexible approach to managing resources and remaining compliant with NCO requirements for the entire generic portfolio.
Noteworthy
In-Home Trial Supply Challenges
CRO's and sponsors are taking clinical trials to homes. These in-home trials can address participation issues and provide added convenience plus support for patients, but they also come with their own set of risks.
Big Changes for EU Medical and In Vitro Diagnostic Device Regulations
The EU is launching a major transition within their legislation for medical and in vitro diagnostic devices. This transition is important and should include assessing the financial viability of the pipeline, expanding data collection, and locking in soon-to-be-scarce notified body resources.
Latest Business and People News
By Applied Clinical Trials Editors
Updated employee announcements, business news, awards, and recognition in the industry today.
E-Books
Emerging BioPharma: Your Guide to Clinical and Commercial Considerations
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.
Preclinical and Early Stage Research
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.
Cancer’s R&D Convergence
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.
Webcasts
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