Drug Safety

Managing the Unmanageable: Meeting the Challenge of Appropriate Safety Report Distribution

January 1, 2018

As clinical trials become more complex and increasingly global, the problem of over-distributing expedited safety reports to investigative sites has reached the point that demands a solution. The excessive volume of safety reports can cause investigators to miss important reports lost in the noise of non-significant event reports, and sometimes cause them to reconsider participating […]

INTERPHEX JAPAN 2017/in-PHARMA JAPAN 2017 concluded with a huge success.

December 7, 2017

INTERPHEX JAPAN 2017 and in-PHARMA JAPAN 2017 were held at Tokyo Big Sight, Japan during 28 -30 June, 2017. Japan’s largest* B-to-B trade show specialised in Pharmaceutical R&D and Manufacturing concluded with a huge success (*in reference to the exhibitor number with the same concept.) 30th anniversary year of INTERPHEX JAPAN ended a remarkable success: […]

Certara Launches Version 17 of its PBPK Simcyp Simulator

December 5, 2017

This year’s Simcyp Simulator enhancements include new oncology and preterm-birth populations, enhanced skin and gut transporter models, and additional regulatory qualification summaries Certara®, the global leader in model-informed drug development and regulatory science, today announced that it has launched version 17 of its Simcyp® Population-based Simulator. “We are proud to introduce several significant advances in […]

Bioclinica Launches Clinical Adjudication Led by Experienced Medical Specialists and Researchers for Enhanced Safety and Efficacy in Clinical Trials

December 4, 2017

Transforms adjudication process, enabling sponsors to meet regulatory requirements using centralized and independent expert clinical event review Bioclinica®, the world-leading provider of technology-enabled solutions for clinical research, today announces the launch of Bioclinica Clinical Adjudication, a transformational offering in which medical specialists and researchers, backed by advanced technology, lead independent Clinical Event Committee (CEC) review. […]

ERT Acquires iCardiac Technologies

December 4, 2017

ERT Acquires iCardiac Technologies Combined organization delivers innovative, efficient safety & efficacy solutions that support all phases of clinical development PHILADELPHIA – December 04, 2017 – ERT, a global data and technology company that minimizes uncertainty and risk in clinical trials, today announced it has acquired iCardiac Technologies, a leading provider of centralized cardiac safety […]

Peptides 2018

November 30, 2017

HPAPI 2018

November 30, 2017