505(b)(2): It’s A Different Animal
Camargo
Service Sectors > Data management
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On-Demand Supplier Webinar
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?
On-Demand Supplier Webinar
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.
On-Demand Supplier Webinar
Using FDA’s Draft Guidance on Risk-Based Monitoring to Improve Clinical Data Quality - Rho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...
On-Demand Supplier Webinar
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...
Product brochure
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...
Case study
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...
Technical / white paper
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...
Technical / white paper
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...
Technical / white paper
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...
Technical / white paper
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...
Technical / white paper
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....
Clinical study
Design and validation of Clinical Rating Scales, Patient Reported Outcomes, Composite Endpoints and Quality of Life Data - Exploristics
06-Sep-2010 -
These instruments provide vital measures of the effectiveness of treatment as well as the general well-being and physical and psychological state of the patient. Exploristics, the innovative Analysis Company, employs a range of analysis methods to evaluate and optimise features...
Technical / white paper
Generate Sales Leads: Free White Paper - William Reed Business Media
02-Aug-2010 -
White papers (or technical papers) are one of the most effective ways to generate leads for your sales team and establish your company’s reputation as a thought leader. Want to know how to create an effective white paper? Download William...
Survey
Are you Asking the Right Questions? - William Reed Business Media
02-Aug-2010 -
Want to evaluate your company’s brand image or the opinion of the Outsourcing-Pharma readers on a certain topic? Want to perform a market research analysis without the hassle? Download William Reed Business Media’s survey brochure to find out how you...
Video
Take Control of Your Clinical Labels - Almac Group
16-Jun-2010 -
LAS is a secure web access workflow management system providing users with instant visibility and control on all their clinical supply labels – greatly reducing the time taken to edit and approve labels throughout your clinical trial. Key Benefits
Instant visibility
Identify...
Technical / white paper
Generate sales leads with a good white paper - William Reed Business Media
24-Mar-2010 -
White papers (or technical papers) are one of the most effective ways to generate leads for your sales team and improve your company’s reputation as an expert. Want to know how to create effective white papers? Download this guide now....
Product brochure
Understanding The 505(b)(2) Approval Pathway - Camargo
27-Jan-2010 -
By the time he founded Camargo Pharmaceutical Services in 2003, Ken Phelps had already amassed more than 30 years of experience in the health science and services industry. With a broad background in drug development, specifically the 505(b)(2) regulatory approval...
Technical / white paper
Discover Hidden Gems in your Clinical Development Portfolio - Exploristics
18-Sep-2009 -
Exploristics have implemented tools that use existing clinical data to identify subgroups of patients that respond to treatment. These tools can be applied at a study or portfolio level and enable an informed and pragmatic approach to development decisions. This...
Technical / white paper
Validation of Pioglitazone in Human Serum by Two Sample Introduction Methods: LDTD-APCI/MS/MS and LC-ESI/MS/MS - BASi
12-Aug-2009 -
BASi’s expanded European facility provides contract research services - preclinical research, toxicology, bioanalysis, method development and pharmaceutical analysis - as well as specialized instrumentation. Download an example method validated by BASi.
On-Demand Supplier Webinar
Increase your webinar performance with expert tips and advice - William Reed Business Media
24-Jun-2009 -
Learn how to maximize registrations and retain viewer attention for your webinars. Get expert advice and tips from the online marketing solutions team at William Reed Business Media. After you attend this free web seminar, you will know how to...
