News

As business grows with the addition of more CROs, questions have arisen from sponsors about how to conduct effective CRO oversight. A survey of clinical leaders provides insights to help address key challenges and regulations more quickly and effectively.

Guido Rasi, Executive Director of the European Medicines Agency, has conceded that the planned exit of the U.K. from the European Union could have a major impact on the activities of the EMA.

Comparing mean vs. median to uncover the full data picture of site-level performance.

The European Medicines Agency will launch a pilot project in February 2017 to test the added value and feasibility of tailored scientific advice for the development of biosimilar medicines.

Schulman IRB has announced that they will join both IRBchoice and SMART IRB Reliance Networks.

Commonwealth Informatics has signed a new contract to support the use of advanced drugs safety tools at the FDA Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research.

The Almac Group has announced a collaboration with cloud-based solution provider Exostar.

Specimatch announced the launch of its web-based software service for cancer patients and oncologists.

PPD has announced an expansion of its stability sample storage capacity and capabilities.

Spare a thought for your Scandinavian colleagues who are running CROs

The Alliance for Clinical Research Excellence and Safety (ACRES) has partnered with the British Standards Institution (BSI) to launch a multi-stakeholder global working party.

Endpoint adjudication is gaining importance in pharma today, however, no guidance on endpoint adjudication currently exists. The LinkedIn Endpoint Adjudication Community has generated an Events Charter Template to shed light on the subject for those in need of guidance.

The advancement of technology has allowed for new solutions to become available in all areas of clinical trials. Patient Recruitment Systems are no exception as they can be used to improve the trial process by optimizing protocols, selecting high potential sites and enabling more studies.

The FDA Amendment Act is on its way toward implementation at years’ end. We reveal the facts on clinical trial disclosure for compliance with these new requirements.

With much happening in the clinical trials industry during 2016, Moe Alsumidaie looks back at some of the innovations that took place. He also looks forward to what the industry can bring us in 2017.

Over the last decade, many initiatives sponsored by various entities, including academic and clinical research centers have focused on efforts to streamline clinical trial eligibility and data collection. Oncology trial design is no exception as endpoints and eligibility criteria have also changed with the value of the data generated in early phase studies.

ERT has announced the acquisition of Exco InTouch.

A European research hospital has selected OmniComm’s TrialMaster electronic data capture (EDC) technology to integrate privacy-protected patient data from the hospital’s electronic health records.