News

Examining interventional vs. non-interventional clinical study classification in the EU.

Click the title above to open the Applied Clinical Trials October/November 2016 issue in an interactive PDF format.

INC Research and the Center for Information and Study on Clinical Research Participation (CISCRP) have announced the winner of the 2016 “Inspiring Hope Ideathon”.

Industry professionals are searching for new technologies to support their trials following approval of an NIH policy supporting single IRB practices. Transparent and auditable systems can offer stakeholders the ability to more effectively monitor and report regulatory responsibilities.

Clinerion has released a new version of its Patient Recruitment System, designed to search electronic health databases of hospitals for eligible clinical trial candidates.

Gene-editing technology has the ability to give oncology researchers an effective treatment option in the fight against cancer. CRISPR-Cas9 is such a technology that is currently being used to study genes in cancer cells.

Most people in our poll said it was a service, but others disagreed. Find out more in this follow-up from Michael Howley PA-C, PhD and Associate Clinical Professor, Department of Marketing at the LeBow School of Business at Drexel University.

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.

Dr. Gonzalo Calvo has been re-elected by the Healthcare Professionals’ Working Party (HCPWP) of the European Medicines Agency (EMA) as its co-chair.

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.