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SERIALISATION - Recipharm AB

17-Mar-2014 - Recipharm already has experience in serialised production. From our UK facility in Manchester over 40 batches have been delivered from a fully validated line to the Turkish market since 2010.Serialisation is a complex area and the requirements are likely to...
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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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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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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. 
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Biosimilars – Landmark Developments Point to the Future for Regulations and Analysis - SGS Life Science Services

30-Aug-2013 - 2013 is a landmark year for biosimilars, with the approval of the first biosimilar mAb and regulatory developments across the globe. Correctly interpreting the analytical requirements in these regulations is critical to demonstrate Biosimilarity. This webinar will review the evolution of...
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Exploring New Frontiers in Direct to Patient Home Delivery Services for Clinical Trials Materials - Marken

07-Aug-2013 - Exploring New Frontiers in Direct to Patient (DTP) Home Delivery Services for Clinical Trial Materials provides an in-depth look at reasons to consider a DTP solution. Included in the discussion are concerns with the traditional distribution channels, advantages and challenges...
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Endpoint Based Protocol Development: A Central Laboratory Perspective - ACM Global Central Laboratory

20-Jun-2013 - The ability to ensure that relevant and accurate laboratory testing is performed, which will meet the primary and secondary endpoints in a clinical trial, is the basic expectation for any central laboratory. Pharmaceutical and biotech organizations, along with CROs continually...
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Conversion of Legacy Data to CDISC - SGS

03-Jun-2013 - Legacy data submitted to the FDA should be in a standardized format. This article is a summary of the FDA´s recommendations to approach the conversion of legacy data to CDISC based on SDTM.
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Supply Chain Issues and Trends in Asia - Marken

02-May-2013 - Import/export of biological samples from China China: Large Pharma Reverse Logistics A Common Issue: Destruction of Drug in Taiwan J-GMP: How is GMP different in Japan? Korea: Biosimilars Hotbed India: Will Regulations Change to Allow Quicker Study Approval in 2013?
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What Non-statisticians Need to Know about Statistics in Clinical Trials - Rho

04-Apr-2013 - Through real-world examples, webinar participants learn strategies for choosing appropriate outcome measures, methods for analysis and randomization, and sample sizes as well as tips for collecting the right data to answer your scientific questions. 
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Using FDA’s Draft Guidance on Risk-Based Monitoring to Improve Clinical Data Quality - Rho

15-Oct-2012 - The Industry’s changing approach to clinical data monitoring requires the tools and team structure to effectively plan and execute risk-based monitoring. Join Lynn King and Rob Woolson as they discuss multi-disciplinary approaches to implementing alternative monitoring plans and specialized tools...
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Cost Effective Data Standards Implementation: How to Integrate CDISC Standards into Your Product - Rho

26-Jun-2012 - Based on recent guidance from FDA, a data standards plan is now expected at the IND stage of development.  Join David Shoemaker, PhD and Jeff Abolafia, MA as they discuss cost effective methods for integrating CDISC data standards into your...
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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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Product & Process Transfer of a Low Solubility Compound with 6 year OTIF >95% - Alkermes

23-Mar-2011 - Alkermes, through the merger with Elan Drug Technologies,to form Alkermes plc,has been developing and manufacturing commercial scale solid oral dosage products for over 40 years.This case study demonstrates the successful transfer of alow solubility compound into one of our manufacturing...
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Reducing Dosing Errors in Preclinical GLP Infusions - Solomon Scientific

09-Feb-2011 - The White Paper explains that the Orchesta™ Automated Infusion System from Solomon Scientific reduces dosing error opportunities by 99% in preclinical GLP infusion studies. The system is validated for GLP and Part 11 compatibility. A typical preclinical GLP infusion study...
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Recommendations for consistent application of RECIST 1.1 - Perceptive Informatics

22-Nov-2010 - Today, the majority of clinical trials evaluating cancer treatments for objective response or progression of disease in solid tumors use RECIST. The new version of RECIST will provide a number of benefits to sponsors including more robust data analysis for...
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Acute Kidney Injury (AKI) Biomarker Program - PBI

27-Oct-2010 - Pacific Biomarkers Inc. has launched a new program to investigate the biological and analytical qualities of biomarkers that current literature and experimental evidence indicate useful for detecting acute kidney, liver, and heart injuries caused by all novel drugs in development.PBI...
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Realise the full potential of your data with Exploristics, the innovative analysis company - Exploristics

28-Sep-2010 - We provide unique expertise in statistical data analysis and we offer a range of solutions for data management, storage, integration, analysis and visualisation. We enable the use of biomarker data in clinical studies through consultancy, training and the development and...
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Thorough QT Trials-Traditional & Alternate Designs - SGS

15-Sep-2010 -  Before the Health Authorities give the green light to put a new drug on the market, they generally request a clinical study dedicated to the evaluation of the potency for this drug to induce or not a QT interval prolongation....

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