News

goBalto, Inc., announced its release of goBalto Select, for cloud-based study startup clinical trials.

This article focuses on the 3 essential factors that have a significant impact on the outcome of any inspection or audit. The author applies this primarily to GCP (Good Clinical Practice) inspections, but the principles are universal, being applicable to any government inspection such as the FDA (U.S. Food & Drug Administration) or industry QA (Quality Assurance) audit.

Valeant is a hedge fund disguised as pharmaceutical company, with the moral at the end of it's story, poor ethics leads to collapse.

Pharmacists have new prominence in a new European system, created jointly with drugmakers and wholesalers and parallel traders, that will provide on-line identity-checks on each individual medicine from factory to pharmacy.

Lagging indicators and superficial averages are increasingly replaced by sophisticated performance metrics and predictive analytics harnessing the power of big and small data.

The Mexico office expands Eurotrials reach in Latin America. Eurotrials also has offices in Brazil, Argentina, Chile, Portugal, and Spain, covering over 15 countries in both Latin America and Europe.

The MHRA is seeking input on identifying new uses for an existing drug in another indication, or creating novel combinations and sees it as "an emerging and dynamic field of drug development."

Nimblify, Inc., developer of a patient-centric payment system and a benchmarking tool for sites, among other technologies, will participate as a Global Impact Partner.

Henlius Biotechnology has selected Medidata’s Medidata Clinical Cloud® platform for its Phase III oncology clinical trial in China.

NAMSA replaced its paper-based system for managing clinical trial documents with Veeva Vault eTMF and has reported that eTMF has reduced the time spent handling files by at least one-third.

PFT Global is the renamed clinical trials division of nSpire Health, which iCardiac acquired in July 2015.

Schulman IRB will serve as the IRB of record for all participating research sites.

The study authors surmised that the lack of validation studies of initial trial results reflected that one goal of open access is not being met. Further, they believe that the limited use indicates a “failure to get the word out “ to researchers.

The impact of the Fourth Industrial Revolution is evident in our everyday lives and healthcare and pharmaceutical industries are no exception and perhaps provide one of the biggest opportunities for a positive impact.

Dr. Christa Wirthumer-Hoche has been elected as the new chair of the Management Board of the European Medicines Agency (EMA).

The dilemma facing clinical operations executives when selecting a CTMS solution to manage clinical trials is to go with an existing approach/solution or explore alternative options.

CRF Health, a provider of eCOA solutions for the life sciences industry, announced its TrialMax® eCOA platform has been selected by a sponsor to capture more than 4.6 million data points via an integrated medical device in a Phase III diabetes program. The program encompasses 3,000 patients across 450 sites in 28 countries using diabetes care devices and patient diaries. Read the full release.

The European Commission has applied to increase the fees payable to EMA by 0.2%, which in line with the 2015 inflation rate.

A number of top-selling biological products in key therapeutic areas such as cancer, diabetes, and rheumatoid arthritis have recently lost, or will soon lose, patent protection.

Clinical trials have increased in number and complexity for numerous reasons-global trials, outsourcing, protocol requirements, and multiple regulatory issues. Factor this with the increased need to bring efficiencies and lower prices to the clinical trial process, and the need to stay on top of trials only becomes more crucial. This eBook will include articles on logistics of clinical trials supplies, negotiating with investigative sites, use of e-signatures and more.