News

The use and awareness of risk-based monitoring is now impacting clinical trials of all sizes, indications and types as a core component more than ever before. Sponsors and sites are expected to expand its use to include all phases of clinical research and all therapeutics areas.

Functional dyspepsia is noted globally as being a common condition that currently has no specific therapy despite years of research. This condition is in need of an operational definition so that drug development and treatment trials can move forward with a more definitive trial design.

Acquisition of function service provider ExecuPharm addresses what PAREXEL sees as a growing trend among biopharm companies to use combinations of outsourcing models.

Cryoport has announced the integration of its Cryoportal logistics solution with Database Integration’s Integrated Cell Therapy Automated Network (iCAN) scheduling platform.

According to results of a new study by the Tufts Center for the Study of Drug Development, the development process for new diabetes and non-diabetes endocrine drugs is riskier compared to all drug development.

Technology innovations have been introduced into the clinical trials space that have the ability to change the trial experience for all involved. Egg’s TRIAL 360 platform is no exception, as its goal is to provide a networking platform to keep investigators and study stakeholders engaged in the trial.

This Best Practice in Study Feasibility report covers techniques and innovations proffered by sponsors and CROs for conducting feasibility analyses.

Antimicrobial resistance presents a challenge on a global scale that has received attention from the United Nations General Assembly among other governing bodies. Research and development for new antimicrobials and alternative medicines is needed to combat such a threat.

A critical challenge that clinical trial researchers face is patient drop out. Why patients fail to complete studies can be attributed to a variety of reasons, and delays in compensation can often be one of them.

The globalization of clinical trials is the subject of this analysis to find if there is an increase in non-traditional sites.

Medidata has announced that Polaris Pharmaceuticals has selected Medidata Payments to integrate its clinical trial site reimbursement process.

Validic has published a research paper depicting the results of a 2016 Global Pharma and Biotech Survey on Digital Health.

After months of debate, clinical research activity regulated or funded by the government must adhere to revised guidelines regarding transparency. A final rule published by the Department of Health and Human Services states that all beyond Phase I FDA regulated and NIH funded clinical trials must comply with the new requirements.

ICON plc has completed its acquisition of Clinical Research Management, Inc. (ClinicalRM), a provider of full service and functional research solutions to U.S. government agencies.

ERT has announced that its electronic Clinical Outcome Assessment (eCOA) solution has assisted CoLucid Pharmaceuticals during its Phase III migraine drug study.

Clinical trials endure high drop out rates due in part to long schedules, high travel costs and long reimbursement times. Outsourcing specialized clinical trial traveling services can help alleviate this concern by allowing sponsors to efficiently manage travel and other expenses.

Pharma has been transitioning from its paper based methods of the past toward automated cloud based systems in order to offset the cost of drug development. The emphasis is now shifting toward improved study startup processes for shorter clinical trial timelines.

Large clinical research enterprises have the resources to establish high standard clinical trial Quality Management Systems, while smaller enterprises may not have the means to do so. This article covers how clinical research enterprises can leverage technologies to develop an efficient clinical trial QMS.

INC Research and the Center for Information and Study on Clinical Research Participation (CISCRP) have announced the finalists for their “Inspiring Hope” Ideathon event.