Blogs

The workings of the European Union are notoriously complicated, with the result that misunderstanding is commonplace, even among those who might like to know more about it.

There have been a number of significant scientific and regulatory milestones driving the adoption of electronic patient-reported outcomes in clinical trials since the first screen-based ePRO solution, Minidoc, appeared in 1980.

Market players working on development of vaccines to fight against the virus are focused on clinical trials and look forward to gaining approval from regulatory bodies.

Columnist Moe Alsumidae speaks to key Synteract executives on their acquisition of a dermatology CRO to augment its own expertise and grow the specific services necessary for this therapeutic specialty.

Researchers are now looking to design their trials around a bring-your-own-device (BYOD) strategy, which allows participants in a clinical trial to provide study data using their own internet-enabled hardware.

To help combat the nation’s opioid epidemic, FDA is promoting a more tailored approach to developing and testing effective analgesics, with the aim of bringing less addictive pain treatments to market more quickly.

Feasibility, the evaluation of whether a particular trial can recruit enough of the right patients so that the study completes on time and within budget, is arguably the most critical part of the clinical trial process.

Peter O’Donnell gauges the impact of FDA guidance on igniting the adaptive pathways debate in Europe.

A look at current strategies from the industry that address the limitations in clinical trials.

Insights into the implementation of IDMP in the EU.

Jill Wechsler details new FDA policies to streamline drug development, including the design of “seamless” trials.

One nonprofit’s efforts to raise the relevance of the clinical research enterprise.

Alzheimer's Prevention Initiative's discusses a genetic counseling and disclosure model for its Generation Program.

The role of the cloud in realizing the practical benefits of mHealth in clinical trials.

Partnership focuses on integrating research into the care continuum.

The relationship between European patients and drug developers has gone through many twists and turns over the years-and is still seeking equilibrium.

Comprehensive market landscaping includes disparate data sets from primary and secondary sources and is a time-consuming process that requires domain expertise and commitment.

Michael Sydes outlines some strategies that CRA's can use to maintain good clinical practices.

As part of efforts to speed patient access to effective new therapies, FDA is rolling out policies designed to streamline drug development, particularly for new cancer therapies to treat life-threatening conditions.

Small and medium-sized businesses are seeking clarification on how the new ICH E6 guidelines will impact their business.

In this article, Moe will elaborate on how to run an effective and engaging social media campaign on Facebook.

It is time for mandatory certification to be required for everyone involved in a clinical study.

CBI, the conference group sister of Applied Clinical Trials, is featuring their Global Risk Based Monitoring Conference in September.

With looming workforce loss-now much higher than first anticipated-prompting further cutback plans at EMA, the threat to drug developers, suppliers, and patients is intensifying.

July has seen one very positive development in the faltering attempts by Europe's governments to resolve that challenge of providing patients with innovative medicines without bankrupting health budgets.

CBI Conference Producer, Trevor Sosvielle, recently sat down with Matthew Amsden, CEO of ProofPilot to discuss his early work in HIV prevention trials. Amsden shares how these experiences helped shape ProofPilot and its patient-centric clinical trial approach.

The last time the ICH GCP Guideline was updated, the process of conducting a clinical trial, including risk assessment and monitoring, was a largely paper-based affair. Since then clinical trials have evolved substantially as they’ve become more complex, costly, and global in scope.

In this interview, Sudip Parikh, SVP and Managing Director of Americas at DIA Global, will discuss the latest industry trends, and how DIA NOW is helping to facilitate information across the clinical trials industry.

James Man considers the practical measures firms can take to embed the patient perspective more directly into their R&D planning.

The question is, how much attention should be paid to historical recruitment figures if the team only reviews the data from one (or two) similar studies?