Important industry news and company updates

Many clinical research professionals become promoted or advance to the higher level supervisory positions after gaining additional qualifications and experience in clinical research. The Clinical Research Managers have a certain set of educational and qualification requirements they have to cover so they can get such positon in the first place and then have a successful career. But let’s first define what the Clinical Research Manager does. He leads programs to develop and trial new drugs. He is responsible for managing the clinical...MORE >

The answers from the successful webinar with one of Astra Nova’s experts On the 13th July 2014 Astra Nova Ltd., the UK-based company dedicated on providing pharma training globally, has organized a webinar for all people from the pharma and clinical research industry, so they can get familiar with the new EU Clinical Trial Regulation and the difference in comparison to the old EU Directive(2001/20/EC). With the help of Mr. Harris, an expert with more than 15 years of progressive experience...MORE >

Since 1996 ICH-GCP has proven to regulators considerable advances in technology. Monitoring and identifying risk has justified all efforts to accomplish safety and compliance of clinical trials, which makes it both beneficial- pharma industry and patients. Looking at the future of the clinical research world, TransCelerate Biopharma Inc., an independent non-profit organization focused on accelerating the development of new medicines and solving fundamental issues pharmaceutical companies face in bringing new therapeutics to market, believes that their Risk-Based Monitoring (RBM) methodology...MORE >

ACRES Alliance broadens to include Astra Nova’s international network of more than 140 global experts and accessible online training courses for clinical research professionals. Cambridge, MA (PRWEB) July 23, 2014 Astra Nova Training, a global provider of innovative and comprehensive consultancy and pharma training services, and the Alliance for Clinical Research Excellence and Safety (ACRES), a non-profit integrating the expertise and investments of research stakeholders worldwide to build and maintain a global system for clinical trials, are pleased to announce a...MORE >

Astra Nova has started working on a brand new GCP training.   The many people who have already used the company’s popular online GCP training provided Astra Nova with useful feedback on course needs. And this valuable feedback is the main purpose that pushed Astra Nova towards developing a brand new training course.   The course not only reviews GCP regulations, but also provides an approach of how those regulations are being applied in professionals’ day-to-day activities. A number of case studies will help...MORE >

New GDP (Good Distribution Practice) Training has just been released by Astra Nova. The new course is now available in the online learning management system of the company and is completely free. The training is fully interactive and is prepared to cover all newly applied Guidelines for GDP. It is also a guide about all the important aspects of keeping up to the terms and regulations coming into place from the 8th of September 2013. The new and completely free GDP...MORE >

Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Supplemental New Drug Application (sNDA) for Eliquis® (apixaban), for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adult patients who have undergone hip or knee replacement surgery. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is March 15, 2014. The submission is...MORE >

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that following the results of a regular safety review of the aleglitazar AleCardio phase III trial, the independent Data and Safety Monitoring Board (DSMB) has recommended to halt the trial due to safety signals and lack of efficacy. Based on this recommendation, Roche has decided to terminate the AleCardio trial and all other trials involving aleglitazar.   “The safety of patients is our first priority. Roche is working with investigators to support the management...MORE >

Astra Nova has released a new, fully interactive and up-to-date GMP (Good Manufacturing Practice) training course. The training is entirely web-based and is designed as a comprehensive learning tool for everyone that wants to learn about the GMP regulations and requirements and latest legislation updates, which came into effect on 31 January 2013. The GMP Training is developed as a refresher course which focuses mainly on the latest GMP legislation changes.  It is intended to help professionals get up to date...MORE >

INC Research LLC, a therapeutically focused global clinical research organization (CRO) with a Trusted Process® for delivering reliable results, today announced the appointment of Ian M. Braithwaite, PhD, as Executive Vice President and General Manager, General Medicine. Dr. Braithwaite brings extensive experience both in the CRO and biopharmaceutical industries to this key role providing global leadership for the Company's General Medicine business unit, which specializes in conducting clinical trials in areas ranging from infectious disease, respiratory disease, women's health, immunology...MORE >