Breaking News on Contract Research, Manufacturing & Clinical Trials

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A Configurable & Cost-effective Randomization Solution for Patient & Supply Chain Management - aXcess™ - Almac Group

16-May-2012 - Almac’s aXcess™, coupled with clinical packaging and distribution bundle, bridges the gap between paperless and web-based drug supply management.  aXcess™ is configurable, can be set up very quickly, and is cost effective.  The system includes features such as language capabilities and...
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PDUFA V: What you need to know about the upcoming Prescription Drug User Fee Act - Rho

25-Apr-2012 - The Prescription Drug and User Fee Act (PDUFA) IV will expire in September 2012. A new version of this legislation, PDUFA V, is expected in the coming months and may have implications for your regulatory strategy and development program. Join...
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A Clinical Perspective on IV Medication Delivery - Baxter

09-Apr-2012 - Management of medication delivery through intravenous (IV) administration is a complex and challenging task for pharmacists.  The information provided reflects research conducted assessing medication delivery practices and preferences.
Download now!Technical / white paper

SGS-Clinical-Influenza Clinical Trials… - SGS

02-Apr-2012 - Development of influenza vaccines is critical; but, there is also a need for new influenza treatments. This article presents an overview of challenges faced when conducting an influenza treatment study based on two recently managed clinical trials. 
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Sample Prep Proposed USP<233> Elemental Impurities - SGS

27-Feb-2012 - Proper sample preparation is crucial when analyzing for trace metals using inductively coupled plasma (ICP). This paper illustrates how solubility of the test article may not be the primary factor when choosing a sample preparation method.
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The Scientific Path to Cycle Development - Baxter

20-Feb-2012 - To optimize lyophilization cycle times and improve stability for complex injectables, Baxter’s BioPharma Solutions contract manufacturing business established the Lyophilization Center of Excellence, an industry-leading resource for development of high-quality freeze drying.
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Overcoming the Challenges of Clinical Trial Supply Distribution - Almac Group

15-Feb-2012 - The distribution of clinical supplies globally can be a challenge for any trial, especially with many new emerging markets. Almac Clinical Services provides contract services to the clinical trial supply industry serving both Pharmaceutical and Biotech companies worldwide and has...
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New Challenges in Early Clinical Development - SGS

24-Jan-2012 - With many new challenges in early clinical development there is pressure to change how early phase clinical trials are conducted where the final goal is to shorten the time to go-no-go decisions and decrease cost. It is increasingly important to...
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Crystallization – Understanding and developing the process - Solvias AG

28-Nov-2011 - In order to achieve controlled production of a desired polymorphic form it is essential to primarily understand the product and be intimately familiar with the process. Furthermore, scaling up the crystallization process requires an expert team of experienced scientists working...
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Application of a partner-driven approach in winning and maintaining outsourced pharmaceutical business - Alkermes

17-Nov-2011 - Alkermes' Contract Pharma Services provides solid dosage form product development, formulation solutions and manufacturing services for the pharmaceutical market. With a long and successful history in the development and manufacture of pharmaceutical dosage forms for pharmaceutical markets worldwide, previously as...
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Improving Signal Detection in Drug Safety - SGS

07-Nov-2011 - Early identification and management of emerging drug safety issues are a major concern of industry stakeholders. Electronic capture systems for AE reporting now allow for faster accumulation of data and the ability to perform complex analysis.
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Securing the Supply Chain: Third-Party Contingency Planning for Clinical Trial Transport - World Courier

01-Nov-2011 - WORLD COURIER is widely recognized as the largest and most experienced specialty courier service with a network of 150 company-owned GxP-compliant, ISO 9001-certified offices operating in 51 countries worldwide. Its superior transport network is complemented by 13 state-of-the-art and fully...
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Camargo: Paws-Down, Your 505(b)(2) Experts - Camargo

17-Oct-2011 - The 505(b)(2) pathway can lead to approval for new drugs in a fraction of the time and cost required by traditional paths; but special requirements demand a thorough understanding of the FDA and its evolving standards. See us at AAPS...
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Clinical Trial Logistics in Africa: Ensuring Quality, Compliance and Control within the Pharmaceutical Supply Chain - World Courier

01-Oct-2011 - In the area of clinical trials, WORLD COURIER delivers unprecedented expertise in the handling, transport, storage and distribution of temperature-sensitive pharmaceutical products and biological specimens in Africa and worldwide. It offers a fully-integrated GxP-compliant pharmaceutical supply chain system, strong knowledge...
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White Paper: Vaccine-Based Clinical Trials - SGS

26-Sep-2011 - Download this paper to read two case studies which illustrate strategies for planning and implanting a vaccine-based infectious disease clinical trial versus a therapeutic-based trial.
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Ensuring Clinical Trial Success in the Russian Federation: Strategies to Manage Temperature-Controlled Logistics - World Courier

01-Sep-2011 - In the area of clinical trials, WORLD COURIER delivers unprecedented expertise in the handling, transport, storage and distribution of temperature-sensitive pharmaceutical products and biological specimens throughout Russia and worldwide. It offers a fully-integrated GxP-compliant global pharmaceutical supply chain system, strong...
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Overcoming the Challenges of Clinical Trial Supply Distribution - Almac Group

16-Jun-2011 - Overcoming the Challenges of Clinical Trial Supply DistributionThe distribution of clinical supplies globally can be a challenge for any trial, especially with many new emerging markets. Almac Clinical Services, a provider of contract services to the clinical trial supply industry...
Download now!Technical / white paper

505(b)(2): Your Product’s Fast Track to Market - Camargo

15-Jun-2011 - Camargo Pharmaceutical Services specializes in the 505(b)(2) pathway globally, executing drug development programs for small and large molecules. A rising tide of submissions attests to the increased importance of the 505(b)(2) approval pathway. Download the technical paper for: An outline of...
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Are you getting the right bioavailability and bioequivalence data for inhalation products you’re developing? - DPT

15-May-2011 - Consider the risk to your development program of not accounting for patient variation in device handling. In this webinar DPT Labs and Proveris Scientific team up to demonstrate how the Ergo system can help you develop the right actuation parameters...
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505(b)(2): Your Product’s Fast Track to Market - Camargo

09-May-2011 - Camargo Pharmaceutical Services executes 505(b)(2) drug development programs for small and large molecules. With 3-5 pre-IND meetings a month and worldwide reach in 26 countries; it’s easy to see how our success breeds your success. Download more on 505(b)(2)
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Win with Networked Drug Development Alliances - INC Research

07-Apr-2011 - New Strategies to Increase Productivity and Mitigate RiskDownload our white paperWith this emerging type of clinical delivery alliance, biopharms can connect with therapeutically focused investors and other experts to create a powerful drug development partnership. Networked drug development alliances enable...
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Key steps to consider when working with a cdmo to identify optimal packaging options - DPT

28-Mar-2011 - There are many factors to take into consideration when selecting or designing a packaging component. Steps involved during the initial stage of the process are extremely important in ensuring that the most optimal packaging is identified. Working with a contract...
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GxP, World Courier and Clinical Trial Transport - World Courier

21-Mar-2011 - Dr. Rüdiger Lomb, World Courier’s Global Director, Quality & Technical Compliance, discusses regulatory compliance within World Courier and key capabilities that transport providers must possess to ensure a secure pharmaceutical supply chain.
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Enhanced Delivery Options for Injectables - Baxter

21-Mar-2011 - Baxter’s Kristie Zinselmeier and BD’s Brian Lynch present a joint discussion of the challenges and opportunities of injectable administration, including global market trends, enhanced delivery case studies and lifecycle management collaboration
Download now!Technical / white paper

Strategies for Safeguarding the Global Pharmaceutical Supply Chain in Emerging Markets - World Courier

28-Feb-2011 - Sponsors can maximize control and manage the risks associated with conducting clinical trials in emerging markets by using two basic strategies − one that addresses potential stumbling blocks outside the pharmaceutical supply chain and another that focuses on pitfalls that...