505(b)(2): It’s A Different Animal
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Service Sectors > Data management
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News headlines
- Clinical Cymru Can Compete on Costs says PRA
- Former RPS CIO's Lawsuit Claims Wrongful Termination
- Executives Raise Questions on Clinical Trial Sponsors’ Oversight of CROs
- PRA Expands Clinical Informatics, Adds New Facility in Wales
- Ohio District Court Ruling Against Medpace Could Set Bar for MSAs
- ACRO Calls for Clarity on FDA Draft Guidance on eSource Trial Data
- Merck, Eisai Reap Savings from Off-Shoring, Outsourcing in China and India
Products
Live 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Using FDA’s Draft Guidance on Risk-Based Monitoring to Improve Clinical Data Quality - Rho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...
Suppliers
A global force in central lab testing
ACM Global Central Lab is a global force in central laboratory testing for clinical trials. We specialise in delivering the highest quality laboratory science in support of clinical research services. Our flexible approach, attention to detail and customer service sets us apart from the competition.
Founded by Ben Chien in 1995, QPS is a GLP/GCP-compliant contract research organization (CRO) that offers the highest grade of discovery, preclinical, and clinical drug development services. From a humble bioanalysis shop, it has grown into a full service CRO of 900+ employees spread across the US, Europe, India and Asia. Today, it offers a wide array of pharmaceutical contract R&D services and its areas of expertise encompass Neuropharmacology, DMPK, Toxicology, Translational Medicine, and Early Stage & Phase II - IV Clinical Research.In recent years, QPS expanded its later stage capabilities and extended its Asia Pacific and European presence by acquiring Qualitix (Taiwan) and JSW Clinical Investigations (Austria). This growth enabled QPS to facilitate global late stage clinical trials of new drug candidates in diverse therapeutic areas. By acquiring toxicology and neuropharmacology units at DCB (Taiwan) and JSW Life Sciences, respectively, QPS increased its preclinical services as well. The company also expanded its Phase I clinic in the Netherlands, in order to meet growing market demands. By constantly upgrading its capacities and skills, QPS is always more than ready to fulfill its promise to deliver superior quality, skilled performance and trusted service to its valued customers. For more information, visit www.qps.com
SGS Life Science Services
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 75,000 employees, SGS operates a network of over 1,350 offices and laboratories around the world.
Almac Group
Integrated Solutions from Research to Commercialisation. Almac is a financially secure, privately owned organisation with over 3,300 employees located within the US and UK. Over 600 companies worldwide, including all the market leaders, use our services, testament itself to the quality, innovation and efficiency of our business as proven over the past 30+ years.
Alkermes Contract Pharma Services
Alkermes Contract Pharma Services provides product development scale-up and manufacturing services to the pharmaceutical market and is part of Alkermes plc. With over 40 years in the service business, we have assisted our blue chip list of partners in the successful launch of multiple products in more than 100 countries, including North America, Europe and Asia.
INC Research
INC Research is a therapeutically focused global clinical research organization (CRO) with unrivaled expertise and a reputation for conducting global clinical development programs of the highest integrity.
Solomon Scientific
The Orchesta™ Automated Infusion System from Solomon Scientific reduces dosing error opportunities by 99% and labor costs by 50% in preclinical GLP infusion studies.
PharmaNet
PharmaNet, a recognized leader of global drug development services to the pharmaceutical, biotechnology, generic drug, and medical device industries, provides comprehensive capabilities in Phase I-IV clinical development, bioanalytical and bioequivalence services, regulatory consulting, staffing, and therapeutic solutions.
A Leading Global Contract Research organization
Established in the UK in 1982, Chiltern has grown steadily and strategically for more than 25 years, building our expertise, systems and client relationships to become one of the world’s leading and most highly trusted Contract Research Organizations.
Famar
Established in 1949, Famar is one of Europe’s leading providers of Contract Development and Commercial Manufacturing services to the pharmaceutical and personal care industries. We are presently within the Top 5 & Top 3 worldwide and in Europe respectively -based on Volumes (700mio packs) and Turnover (€ 380M).
