
Focus on data generation that supports decision making by both regulators and health-technology assessment bodies

Focus on data generation that supports decision making by both regulators and health-technology assessment bodies

New offering improves the quality and predictability of clinical development while reducing overall trial costs by up to 25 percent


The Berlin-based clinical contract research organizations, ICRC-Weyer and Allied Clinical Management, have announced that they have entered into a strategic alliance, as part of the newly founded MEDIS Research Group

We'll start our monthly metrics blog with a basic but crucial MCC Clinical Trial Performance metric: on-time site initiation.

Synexus has formed a partnership with Northumbria Healthcare NHS Foundation Trust to establish a clinical research facility at Hexham General Hospital, in North East England.

endpoint, a provider of Integrated Voice Response (IVR) and Integrated Web Response (IWR) systems, announced today its expansion into Europe with a European HQ office expected to open in early 2014.

Scimega Research, a Canadian-based specialty oncology clinical research organization, is pleased to announce that it has been selected by The Quebec - Clinical Research Organization in Cancer (Q-CROC) to successfully oversee the conduct of three of pivotal studies to identify predictive biomarkers in drug-resistant tumors.

ICONIK Labs allows visualisation, analysis and reporting on laboratory data in real time

The partnership is based on Oncodesign's Nanocyclix(R) technology platform for next generation kinase inhibitors and UCB?s expertise in neurology

This new country approval is the beginning of a big expansion of CEL-SCI?s Phase III clinical trial to about 20 countries.

Genetic Alliance & PhRMA Announce Pilot Initiative to Advance Patient-Focused Drug Development

As the pharmaceutical industry continues to face increasing cost of drug development, sample banking for future clinical research provides the pharmaceutical industry with new opportunities to obtain biological sample collections that will allow it to investigate safety and efficacy in future clinical research and answer regulatory authority questions related to safety and efficacy at the time of registration.

Sample banking for future clinical research provides the pharmaceutical industry with new opportunities to obtain biological sample collections.

The European Medicines Agency (EMA) and the United States Food and Drug AdministrationExternal link icon (US FDA) have published a second joint question-and-answer document that provides guidance on the quality-by-design concept.

Wingspan announces that Actelion Pharmaceuticals, a top 20 biopharmaceutical company, has selected Wingspan eTMF as its official electronic trial master file.

ACT 2014 e-media kit

Editorial Director Lisa Henderson talks with N

If you are in clinical research, you may read a headline such as "Thomson Reuters Previews Game-Changing New Solutions for Insights into Clinical Trials" with passing curiosity... along the lines of "what do they have to do with clinical trials?"

Cloud computing is changing enterprise across all industries, and the recent success of Veeva's IPO is further evidence that the life science industry is no exception.

Given FDA's new guidance on risk-based monitoring (RBM), there has been a lot of interest on identifying critical data points, drafting RBM plans, and executing RBM.

Policies to widen access to patient level data from clinical trials are gaining traction, despite strong opposition from research sponsors that such initiatives will undermine patient privacy and incentives for new drug development.


The European Forum for Good Clinical Practice has a vital role to play in bringing together all stakeholders to work out how to discharge their responsibilities in the framework of the clinical trial protocol for the protection of each consenting participant

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

Regulatory: Successful Phase III Trial Monitoring Trial Design: Multi-regional Trials Data Evaluation Also in this issue: Compromise in Europe's Rule Debate True Potential of Adaptive Trial Designs Bring Your Own Device

Venn Life Sciences, a growing CRO announces that it has signed a conditional agreement for the acquisition of the trade and certain business assets and liabilities of CRM Clinical Trials GmbH, a German based CRO, for a total consideration of 0.6m Euro.

April might be - as T S Eliot suggested - the cruellest month, but for pharmaceuticals in Europe, this October is certainly a contender to win an award as the busiest month.

Clinovo released a new version of ClinCapture, its advanced open source Electronic Data Capture (EDC) system.