SGS Expands Viral Challenge Testing Facility Within Its Clinical Unit In Antwerp - Belgium
Promise - and Problems - Signal Mixed Year Ahead for Big Pharma
Small Clinical Trials Feasible for New Limited-Population Approval Pathway
Spaulding Clinical Research Expands Clinical Pharmacology Facility With 12-Bed First-In-Human, High-Visibility Unit
Quintiles Files Registration Statement for Initial Public Offering
OIG Says FDA Lacks Comprehensive REMS Data
CROMSOURCE Further Expands Polish Operations
Resolving The Conflict Over Surging Clinical Trial Costs & Sluggish Enrollment
K&L Consulting Services, Inc. of Fort Washington, PA Selects OpenClinica Enterprise Clinical Trial Software
BBK Worldwide Launches Expanded Suite Of Retention Products To Support Clinical Trial Study Sites
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 February 2013
OpenClinica Announces 2013 Global Conference
Oracle Unveils New Version of Oracle Health Sciences ClearTrial Plan and Source Cloud Service
Exco InTouch Joins Critical Path Institute ePRO Consortium to Advance Electronic Data Capture in Clinical Trials
Phase I Trials Take on Greater Budgetary Importance
ERT, Johns Hopkins University and the University of Washington Expand Study on Effects of Home-Health Monitoring on Exacerbations of Cystic Fibrosis
Avoca Quality Consortium Announces 2013 Key Initiatives
CRF Health's TrialMax ePRO Instrument Achieves Validation Standard
Regulatory Landscape Changes in Russia
Russian regulators have reportedly implemented the much awaited changes to the nation's regulatory process for medical devices, and the revised regulations took effect at the start of January.
Cutting Our Losses in Translation
To reduce the time from bench to bedside we need to transform competition into cooperation.
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Medicare and the NCD
While there is no single correct way to develop process compliance controls to meet federal clinical trials billing regulations around Medicare, standardization of the entire billing process is key.
Central Lab Review Prevent Underpowered Studies
The sponsor of a recent Phase II global study, conducted at more than 50 sites, invested in a centralized digital pathology core lab to ensure a homogenous and representative study population.
Between 2004 and 2012, the Number of Endpoints per Protocol has Nearly Doubled
Tufts CSDD
FDA Speeds More Breakthrough Drugs to Market
The Food and Drug Administration approved nearly 40 new drugs in 2012, beating most recent totals, and is looking for provisions of the FDA Safety & Innovation Act (FDASIA) to further improve its operations and encourage innovation.
Business and People: February 2013
Options have emerged that make DIY EDC technology more accessible to smaller organizations.
Applied Clinical Trials Digital Edition - February 2013
CRO/SPONSOR : Trials in the Baltics eCLINICAL : DIY EDC Technology, Evaluation and Selection Also in this issue : Transforming Competition into Cooperation, Fellowships in Africa, Trial Planning and Execution
The University of Texas MD Anderson Cancer Center Selects Oracle Applications and Technology as Part of Platform to Help Transform Cancer Care
Are E-Patients Overwhelmed?
Coalition for Accelerating Standards and Therapies (CFAST) Announces a Resource for Parkinson's Disease Clinical Development