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The whole blood assay: Detection of broad spectrum of pyrogens & examples of medical device testing - Merck Millipore microbial industry

09-Mar-2015 - Pyrogens in pharmaceuticals, medical devices, biotherapeutics and cosmetics can cause fevers in humans and are potentially life-threatening. Yet standard pyrogen detection methods have drawbacks. The Limulus Amoebocyte Lysate (LAL) test only identifies endotoxins, while the rabbit pyrogen test (RPT) endangers...
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Mobile ePRO makes a difference: Trigemina’s TI-001 formulation including intranasal oxytocin clinical study - Exco InTouch

18-Nov-2014 - Trigemina is a clinical stage specialty pharmaceutical company that develops non-narcotic, nasally delivered, analgesic drug products including TI-001, a patented application of oxytocin with a novel mode of action, which is currently in a phase II clinical study for high...
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7 Common Myths about QP Training Debunked - A Guide for Senior Managers -

04-Nov-2014 - The role of the Qualified Person (QP) in the pharmaceutical industry is mandated by law1. Every holder of a relevant Manufacturers Authorisation (human and veterinary) must have at least one QP; without one, no batch of medicinal product can be...
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Process Transfer Excellence – Basis for a fast and successful project - BOEHRINGER INGELHEIM GmbH

30-Sep-2014 - This whitepaper will focus on the interaction and collaboration with externals customers when transferring processes from a customer to one of Boehringer Ingelheim’s manufacturing sites.Boehringer Ingelheim is one of the world’s leading companies for contract development and manufacturing of biopharmaceuticals....
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Getting more value out of your partnership with a CMO - Hospira inc

20-Aug-2014 - In the article, published in the Strategic Alliance Magazine, one of the leading injectable product CMOs takes a unique stand on managing customer relationships. The article explains how principles of Alliance Management, which has found a wide application in building...
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Veristat and Karyopharm Therapeutics Inc. Agreement - Veristat, LLC

20-Jun-2014 - HOLLISTON, Mass. – June 15, 2014 – Veristat, a full service Contract Research Organization, announced today that Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets...
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Learn the risk factors of metabolic syndrome and the role central labs play in aiding its detection - ACM Global Central Laboratory

17-Jun-2014 - Metabolic syndrome, a serious condition impacting adults and children in all genders, races and ethnicities, can lead to fatal outcomes if not detected and treated. The key risk factors of metabolic syndrome were identified approximately 250 years ago. However, there...
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Industry leading titers of protein in E.coli - Fujifilm

26-May-2014 - The development of large scale E. coli expression systems can be rate limiting in process development.  Fujifilm's pAVEway™ system combines innovative vector technology with platform fermentation processes to rapidly delivers industry leading titers.
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The Promise and Challenge of Adaptive Design: Oncology Trials - Medpace

05-May-2014 - Incorporating adaptive design methodologies into clinical trials can reduce costs while maintaining trial integrity.  Learn how these design strategies can improve the effectiveness and efficiency of oncology studies
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Orthotopic Brain Tumor Models Improved with Imaging - Molecular Imaging Inc.

14-Apr-2014 - Know more: enhance in vivo pharmacology with imaging. Recent tumor model development and informative imaging technologies have enabled the efficient and robust use of orthotopic models. These models have proven to be the most clinically relevant and predictive cancer models....
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High Potency Manufacturing - Key selection criteria when evaluating an outsourcing partner - Alkermes

08-Apr-2014 - Many companies are choosing to outsource the manufacture of their highly potent compounds.  A provider of contract pharma services in high potent manufacturing, Alkermes Contract Pharma Services, outlines elements that should be considered  when outsourcing secondary processing (i.e. dosage form...
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Forecasting strategies to optimize clinical trials - Almac Group

03-Mar-2014 - In a market that is constantly evolving, where rising complexities and costs associated with product development and clinical trial conduct present new clinical supply chain challenges, conventional forecasting methods may not provide an adequate solution.  Add to this the increasing...
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Clinical Document distribution - Secure and Automated - PharmaSOL

08-Jan-2014 - psiXchange automates the distribution of your safety related documents. The distribution engine handles country specific rules and user specific escalation paths, with full receipt tracking. Recipients don't have to learn a new system, and your internal overhead is dramatically reduced.psiXchange...
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Joint Risk Assessment During Technical Transfer – A Framework for Donor and Recipient Companies - Alkermes

11-Dec-2013 - Every technical (tech) transfer is different, with companies taking different paths toward reaching their goal. Each one presents a unique set of challenges. These challenges are most often technical, but at times they may also be business related. However all...
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Controlled Release and Bioavailability Enhancement -

28-Oct-2013 - Metrics provides product development that leverages proprietary pharmaceutical technologies in the areas of: •    Customized Controlled Release Drug Delivery •    Bioavailability Enhancement •    Taste Masking (liquid and solid presentations)When applied appropriately, these technologies can deliver therapeutic and convenience benefits to...
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New Guidelines for Stabilization of Proteins by Freeze Drying: Formulation and Process Heresy - Baxter

17-Oct-2013 - Over the years a number of informal guidelines or “rules” for the formulation and processing of proteins for freeze-drying have been developed. However, in recent years it has become obvious that some of these rules need modification. In this presentation,...
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23-Sep-2013 - To understand why there is so much buzz in the pharmaceutical world for a better HCV treat­ment, as with most things, you have to start with history. This article will highlight the history, why there is a growing need for...
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Patient Reminders: Improve Retention & Compliance - Cenduit

02-Sep-2013 - The average cost of a patient lost to follow-up is $5,000.  Read on to learn how to incorporate patient reminders into your protocol to reduce cost and resource wastage associated with patient noncompliance and early withdrawal. 
Download now!Technical / white paper

(b)(2) or not (b)(2)? That is the question. - Camargo

19-Aug-2013 - 505(b)(2) is more than a regulatory pathway - for many, it’s a unique strategy that can often result in product approval with lower risk, reduced development cost and faster speed to market. So, is (b)(2) for you? To find out...
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Antibody Drug Conjugate Development and Manufacture - Piramal

03-May-2013 - With the recent approvals of brentuximab vedotin (Adcetris) and ado-trastuzumab emtansine (Kadcyla,T-DM1), antibody–drug conjugates (ADCs)are a rapidly growing area in oncology with great potential. Development and manufacture of ADCs can be a challenge with the requirement to handle both biologics...

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