News

The EMA has appointed Grzegorz Cessak as its vice-chair of management for the next three years.

Medidata and the Society for Clinical Research Sites (SCRS) have announced the launch of a clinical trial Site Advisory Group (SAG).

Updated employee announcements, business news and recognition in the industry today.

Globalization has increasingly become a part of the clinical trial landscape as pharma sponsors conduct trials internationally. With language barriers being among the challenges of this process, translation management is now a must during the planning phase of a global trial.

Clinical research in China has shown potential as many biopharma companies look to enter the market, though the infrastructure is lacking. Peter Schiemann, PhD conveys his perspectives on the challenges that sponsors are facing in China.

PAREXEL has announced the launch of its new active tracking service.

The Pediatric Working Group of EUCROF launched an initiative to achieve standardization of generic Informed Consent Form and Assent Form templates within European countries. The differences are noted based on a prior survey.

The need for biopharma to demonstrate the value of medical products is changing trial design in order to generate real world data. Dr. Catherine Bonuccelli of GSK discusses the Salford Lung Study, its patient-centric design and how it differs from randomized clinical trials.

Quintiles and IMS Health have successfully completed its merger to become Quintiles IMS Holdings, also known as QuintilesIMS.

The National Board of Medical Examiners (NBME) has introduced the Certification of Excellence in Clinical Research (CECR).

The discussion on the main characteristics and implementation of the new Clinical Trials Regulation is heating up in Europe.

Survey drills down on the preferred methods of sponsors, CROs, and sites in conducting feasibility analysis.

Updated guidance incorporates the use of a patient-reported outcomes questionnaire-which could enable more endpoints and greater patient stratification for COPD trials.

Study collects first comprehensive metrics on current supply management and distribution practices.

An overview of clinical supply blinding methods in the context of the current research environment.

From basic blood draws to more involved samples, keeping accurate track and records is crucial for trials.

Using strategic planning to address hurdles in biosimilar development programs from the outset.

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.