News

Identifying Key Risk Indicators (KRIs) is an important step in successfully applying risk-based monitoring initiatives to a clinical trial. These factors, within risk management, assist by defining risk areas in order to measure and monitor them centrally throughout the trial.

Identity trust platforms assure clinical investigators that their credentials are legitimate by allowing use of a single identity that can be recognized across multiple entities. These platforms support collaboration by allowing drug development participants to access data, sign and exchange documents.

Regardless of whether the UK does decide to leave the EU or not, the concern over medication will remain for the rest of Europe. The needs of these countries will persist at a human and public health level for more effective medicines and more effective ways of paying for them.

A key function in clinical trials, patient enrollment, has fallen behind during a time where technology has played a vital role in the industry. Adaptive patient recruitment allows for clinical data to be collected and reviewed in real-time as to improve enrollment outcomes as they are taking place.

Bracket releases a new series of mobile applications to support clinical trials.

Autism Spectrum Disorder (ASD) is a common neurodevelopmental disorder which does not have an approved medication to address its core symptoms. The Janssen Autism Knowledge Engine (JAKE) was designed to advance the clinical research process for autism by integrating emerging technologies into traditional clinical trial processes.

Despite challenges in the pharma sector, we are experiencing a technological shift in the way clinical research data is obtained from patients. New devices have allowed for the collection, reporting and response to data from a patient’s body using sensor technology.

Genocea Biosciences has partnered with Wingspan Technology to implement Wingspan’s compliant electronic TMF system.

The Clinical Trials Transformation Initiative (CTTI) released new recommendations for enhancing the efficiency of clinical trial recruitment.

MedNet Solutions and Algorics have announced a partnership to improve risk based monitoring functionality to MedNet’s consumers through the integration of their products.

PAREXEL has opened a North American Coordination Hub and Distribution Center in Pennsylvania.

CDISC and TransCelerate announce new Therapuetic Area Standard for Breast Cancer, which allows for data to be shared among industry professionals.

ERT announces it has successfully integrated the fractional exhaled Nitric Oxide (FeNO) measurement device by Aerocrine, a Circassia subsidiary, into it’s diagnostic platform for spirometry, ECG and home monitoring for centralized clinical trials.

Pfizer has created a clinical trial modeling tool for mitigating study risk during the protocol design and study execution phases. Jonathan Rowe speaks with Moe Alsumidaie on the purpose behind these predictive models.

CRF Health launches Trial Consent, an electronic consent solution that integrates within an eCOA platform.

Oncology remains the therapeutic area with the most drug failures, the lowest numbers of patients enrolled and the highest with the number of drugs in clinical trials. Many trends in oncology clinical trials seek to address these challenges and include the use of biomarkers, immunotherapies, and adaptive designs.

Updated employee announcements, business awards and recognition, and company news.