News

Representatives of FDA, EMEA and industry discussed their pilot program to provide parallel scientific advice to sponsors developing new drugs. The process aims to resolve critical clinical and safety issues early in the research process to avoid duplicative testing and regulatory delay.

In an afternoon session examining innovations in the development of anticancer medicines, speakers from the research, therapeutic, regulatory and industry perspectives discussed "Changing the Paradigm: Innovative Oncology Drug Clinical Development Programs in the Age of the Critical Path and Personalized Medicine."

In a Monday morning session entitled "Patient-Reported Outcome Instruments: Overview and Comments on the FDA Guidance," CDER officials stressed the importance of including PROs early in the clinical trial planning process, rather than at data analysis stages. Edwin P. Rock, MD, PhD, medical officer, division of drug oncology products, described the endpoint model/conceptual framework that organizes the amount/type of data for various uses.

Multiple partnerships formed over past year using SAS Drug Development, SAS Enterprise Intelligence Platform

Solution addresses biomarkers, incorporates molecular information

Acquisition will expand clinical pharmacology bed capacity and broaden Covance's access to special patient populations for Phase Ib/IIa studies.

Combined Advanced Technologies Enable Both Traditional and Adaptive Clinical Trials

BBK Adds Global Alliances and Restructures Offerings to Advance Patient Recruitment.

InForm Adapter, Available Immediately, Strengthens Integration with Existing Customer Data and Systems.

CoSign electronic signature reduces the time and cost of clinical trials, helping sponsors and CROs comply with the FDA's 21 CFR Part 11 and GxP regulations.

Green Mountain Logic will unveil LabPAS/CT Version 2.5 at the DIA Annual Meeting.

DataLabs is the first vendor to implement electronic signatures out-of-the-box guaranteeing signer authenticity and data integrity.

Datafarm announces the release of a simple and cost effective Web-based eCTD viewer for companies of all sizes.

New integration platform leverages a library of predefined connectors and allows clients to write their own custom connectors, easing the pain of creating and managing system integrations.

TrialMaster V.4.0. is a flexible, painless, and affordable eClinical Solution.

Welcome, Awards Presentation, Keynote Address and Hot Topics

Ultra-Scan's TouchLink Solution Allows CROs to Accurately Identify Patients and Ensure Study Integrity.

OneClinical Provides a Full Spectrum of Software Products and Services for the Regulated Life Sciences Industry.

Plenary sessions

Electronic solutions such as IVR systems, PDAs, and digital pens exhibit advantages over paper and pencil in PRO data collection.

PHT company profile

BioResearch Monitors Company Profile

Tools for Clinical Trials Professionals

A comprehensive list of Web sites that contain trial and registry information for both professionals and potential participants

Exhibitor Profiles from the DIA meeting hall

EU (European Commission and EMEA) and FDA agree on guiding principles for joint FDA EMEA voluntary genomic data submission briefing meetings

The American Society of Clinical Oncology (ASCO) has updated its clinical practice guideline recommendations on the use of antiemetics with chemotherapy and radiation.

Averion Expands Operations to Europe and Names John Shillingford, PhD as President of New Wholly-Owned Subsidiary Averion GmbH