news roundup

Cenduit Launches Professional Services Division

Cenduit’s division will provide hands-on experience for managing and enhancing Interactive Response Technology (IRT) systems.

Frenova Creates Nephrology Investigator Alliance

The 200 investigators provide care to approximately 600,000 kidney disease patients.

PPD Enhances Central Lab Features for Sites

The changes will enable study sites to access central lab data in real time, improve inventory management and order tracking, facilitate patient management and safety and more.

Regulatory

Anti-Clotting Drug Faces Questions Due to Device Issues

An investigation published by The BMJ has raised concerns from the U.S. and European regulators about the validity of a pivotal trial.

French Authority Investigates Phase I Trial Death

The French national drug safety agency released the timeline of events for the Phase I clinical trial of BIA 10-2474.

FDA Looks to Technology

With clinical research expert Robert Califf slated to take the helm of the agency, initiatives to streamline trials will be a prime area of focus.

EMA Adopts New Strategy on Pharmacovigilance

The new approach adopted by the EMA's Pharmacovigilance Risk Assessment Committee builds on existing activities in the member states and the agency.

Articles

An Ideal SOP System

A survey conducted in Germany has shown that in the pharmaceutical environment, the number of SOPs and related documents is increasing.

Ask the editor

Lisa Henderson
Editor in Chief
lhenderson@advanstar.com