Applied Clinical Trials-08-01-2013

The EMA is committed not just to greater accessibility of data, but proactive publication.

Central statistical monitoring can improve RBM solutions by efficiently detecting errors, sloppiness, tampering, and fraud.

Everyone is looking to rev up the biopharmaceutical development pipeline, and the FDA is working hard to do its part.

The reality of risk-based monitoring: history and successful implementation for late phase research.

The implementation of best practices for clinical study and development conduct can streamline administrative burdens for investigator staff as well as study teams, and hopefully yield reduced costs in conducting global clinical development.

Are clinical trial data shared sufficiently today?

Survey appraises the use of SOPs in clinical research from the sponsors' point of view.

The goal is to have an evidence development framework that can answer a range of questions simultaneously.

The eClinical Forum Risk Based Monitoring Taskforce offers some best practices for ensuring clinical data quality.

S

The use of RBM may be the only way forward as long as the development of medicines relies on clinical testing.

Risk-based monitoring ushers in the move from the traditional experimental design.

IMS Health

S

Industry news focusing on the people and organizations who work in the clinical trials profession.

The next 18 to 24 months may bring profound changes for investigative sites.

Trial Design: Risk-based Approaches: Best Practices for Ensuring Clinical Data Quality Regulatory: Clinical Research SOPs Also in this issue: Transparency in Europe Fragmented Study Conduct Landscape Comprehensive Evidence Development