Clinical Trial Services
FEATURED REPORTS
WHAT'S NEW
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Instantaneous Microbial Detection
by BioVigilant Systems Inc.
White paper
This white paper by BioVigilant Systems Inc. discusses its optical technology, which can determine the quantity and size of particles in liquid or air and whether each particle is inert or biologic, resulting in instantaneous and continuous microbial detection.
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Fault tolerance is the missing ingredient in the pharma drive for process ...
by Stratus Technologies
White paper
This white paper by Stratus Technologies outlines the pharma industry's need for fault-tolerant computing, based on growing needs for electronic batch record (EBR) and process analytical technology (PAT) information systems.
REPORTS BY SUBTOPIC
Optimizing enterprise information security compliance
By VeriSign Inc.
White paper
This white paper by VeriSign explains information-security compliance and auditing among companies that must contend not only with internal, federal and industry-specific regulations and policies, but also with security practices and requirements of their networked partners, suppliers and customers.
Compliance challenges with enterprise application integration
By Clarkston Consulting
White paper
This white paper by Clarkston Consulting describes challenges faced by life sciences companies to meet 21 CFR Part 11 regulations with respect to enterprise application integration.
Compliance and mobile computing
By Intermec Technologies Corp.
White paper
This white paper by Intermec Technologies describes compliance and mobile computing concepts, including steps to secure mobile applications, best practices of mobile computing, and automatic identification and data capture (AIDC) to store securely sensitive customer data.
Bar codes and manufacturing
By Zebra Technologies Corp.
White paper
This white paper by Zebra Technologies Corp. enters a manufacturing facility and provides an overview of the many applications of bar coding.
21 CFR Part 11 remediation strategies
By Eurotherm Inc.
White paper
This white paper by Eurotherm Inc. describes ways to achieve compliance with the requirements of 21 CFR Part 11, specifically regarding the use of electronic records, and the role of remediation.
Automating document change control
By MasterControl Inc.
White paper
This white paper by MasterControl Inc. describes the quality system lifecycle and the capabilities necessary to automate change control processes to increase efficiency and ensure Food and Drug Administration compliance.
Product positioning
By MasterControl Inc.
White paper
This white paper by MasterControl Inc. describes 21 CFR Part 11 regulations regarding electronic signatures and document encryption.
Fault tolerance is the missing ingredient in the pharma drive for process ...
By Stratus Technologies
White paper
This white paper by Stratus Technologies outlines the pharma industry's need for fault-tolerant computing, based on growing needs for electronic batch record (EBR) and process analytical technology (PAT) information systems.
An enterprise issue, not a point solution
By Clarkston Consulting
White paper
This white paper by Clarkston Consulting shows how life sciences companies can facilitate the FDA's 21 CFR Part 11 regulations through a compliance program office.
Compliance versus competitive advantage
By Clarkston Consulting
White paper
This white paper by Clarkston Consulting describes how chief information officers can consider compliance from a strategic point of view, including addressing education, internal reviews, problem areas and audits.
Instantaneous Microbial Detection
By BioVigilant Systems Inc.
White paper
This white paper by BioVigilant Systems Inc. discusses its optical technology, which can determine the quantity and size of particles in liquid or air and whether each particle is inert or biologic, resulting in instantaneous and continuous microbial detection.
Fault tolerance is the missing ingredient in the pharma drive for process ...
By Stratus Technologies
White paper
This white paper by Stratus Technologies outlines the pharma industry's need for fault-tolerant computing, based on growing needs for electronic batch record (EBR) and process analytical technology (PAT) information systems.
Symposium on risk in supply chains
By Product Surety Center
White paper
This white paper is based on a variety of discussions from a 2005 symposium of the Product Surety Center (PSC), a resource center for industries and government agencies involved in ensuring the security and safety of products. The addressed what it characterized as an overlooked player in U.S. safety and security -- the private sector and its global supply chains.
Improving employee performance and compliance in the life science industries
By Blue Mountain Quality Resources Inc.
White paper
This white paper by Blue Mountain Quality Resources Inc. discusses the importance of employee performance and training, including in areas such as regulatory asset management.
Integrating good manufacturing practices during the transition from clinical ...
By Ross Systems Inc.
White paper
According to this white paper by Ross Systems Inc., early adoption of good manufacturing practice (GMP) can lead to a faster, lower-cost ramp-up from clinical trials to full commercial manufacturing, whether in house or outsourced.
Leveraging IT to transform drug discovery
By Infosys Technologies Ltd.
White paper
This white paper by Infosys Technologies Ltd. describes how a hypothetical plasma therapeutics company leveraged information technology to reduce drug development costs.
Customer and Quintiles team up for greater speed
By Quintiles Transnational Corp.
White paper
In this case study, Quintiles Transnational meets the requests of a top 10 pharmaceutical company looking to reduce the time to database lock by two months.
Regulatory compliance in life sciences: Leveraging integration competency ...
By Informatica Corp.
White paper
This white paper by Informatica Corp. examines some of the issues regarding implementing information risk management technologies to increase compliance in the life sciences sector.
The essentials of stability test services
By MDS Pharma Services
White paper
This white paper by MDS Pharma Services describes the testing that a drug must undergo before it is launched in the market.
Drug Formulation Options - Oral technologies
By Cardinal Health
Product collateral
Cardinal Health provides many formulation options to give pharmaceutical companies a competitive edge. Cardinal Health has developed and manufactured advanced drug delivery stystems for more than 50 years and continue to help enhance the therapeutic and market performance of their customers' drugs. <BR>
Ultrasonics beats optical methods for measuring some critical attributes
By Ultrasonic Scientific Ltd.
White paper
In this white paper by Ultrasonic Scientific, high-resolution ultrasonic spectroscopy (HR-US) is shown to be a powerful tool for pharmaceutical companies in developing new products and optimizing existing ones, as well as in an installation of process analytical technology (PAT).
Optimizing asset management to comply with 21 CFR Part 11 requirements
By Infor
Case study
In this case study, Infor helps a leading pharmaceutical company optimize asset management in compliance with FDA's 21 CFR Part 11 requirements.
United Devices implements breakthrough technology for clinical development ...
By United Devices Inc.
Case study
In this case study, United Devices improves GlaxoSmithKline's efficiency in modeling and simulation using a grid solution, which reduced project timeframes and analysis cost and improved development decision capability.
Intel and United Devices team up to speed cancer research grid
By United Devices Inc.
Case study
In this case study, Intel and United Devices demonstrate how the Grid MP platform can improve the scope and speed of the drug discovery process and screening 15,000 molecules per second while maintaining a secure research environment.
Accelerating the discovery of a smallpox cure
By United Devices Inc.
Case study
In this case study, United Devices, IBM and Accelrys team up to provide accelerated drug discovery research that employs computational chemistry on a massive distributed computing grid to analyze candidates for a medical therapy to fight the smallpox virus.
Calibration Manager and 21 CFR Part 11 electronic signatures and records
By Blue Mountain Quality Resources Inc.
White paper
This white paper by Blue Mountain Quality Resources Inc. explains the role of Calibration Manager, a database application designed to help meet record-keeping requirements of the FDA's 21 CFR Part 11.
GMP calibration software implementations: Containing costs and managing risk
By Blue Mountain Quality Resources Inc.
White paper
This white paper by Blue Mountain Quality Resources Inc. explores good manufacturing practice (GMP) calibration software and the potential for outsourcing all or part of the implementation.
CMX calibration management software
By Beamex
Product collateral
Beamex announces its CMX calibration management software for pharmaceutical applications and support.
QD3 Quality Documenter calibration software
By Beamex
Product collateral
Beamex announces its QD3 Quality Documenter calibration software for pharmaceutical applications and support.
cGMP Informatics: IT Infrastructure Design for 21st Century Pharmaceutical QC...
By VelQuest Corp.
White paper
This white paper from VelQuest Corp. outlines a three-tiered IT architecture combining an ERP platform, a LIMS system, and a GMP Electronic Notebook to improve productivity, cost and compliance for pharmaceutical manufacturers.
Phase II-IV Clinical Trials Services
By AAI Pharma Inc.
Product collateral
AAIPharma's Phase II-IV Clinical Trials services offers highly qualified clinical research teams including project managers, physicians and scientists, clinical research associates (CRAs), biostatisticians, data managers, medical writers, quality and regulatory specialists, working relationships with a network of study sites around the world, and eClinical technologies to assure critical path...
Screening for mutations of androgen receptor gene by single-strand ...
By GE Healthcare Bio-Sciences
Application note
In this application note, GE Healthcare Biosciences discusses the androgen receptor, an intracellular transcription factor that regulates sexual development, spermatogenesis in the male and single-strand conformation polymorphism (SSCP), a technique useful in screening for mutations in the androgen receptor.
Bioassay Development Services
By Cardinal Health
Product collateral
<P>Cardinal Health's approach to bioassay optimization evaluates the existing assay under non-cGMP conditions at a selected end point, confirms the negative control (product), prepares and validates master or working cell banks, optimizes cell numbers and preassay conditions, defines parallelism regions, and runs under cGMP conditions. </P>
Development and validation of in-vitro assay for the release of estrogen from...
By AAI Pharma Inc.
White paper
This white paper by AAI Development Services explains the development and validation of an in-vitro release method for determination of the release of Estrasorb from a lotion.
Eliminating bacteria from infant formula
By DuPont Qualicon
Case study
In this case study, DuPont Qualicon helps a European company isolate a microbe that was consistently contaminating batches of infant formula at three of its factories.
Automated SFC method development: optimization of ibuprofen separation using ...
By Thar Technologies
White paper
This white paper by Thar Technologies Inc. describes the optimization of ibuprofen separation using a superpure discovery analytical supercritical fluid chromatography (SFC) instrument.
Developmental and Reproductive Toxicology (DART) Testing
By Covance Inc.
Product collateral
Covance offers Developmental and Reproductive Toxicology Testing in neonatal/juvenile animals.
Genomic Isolation, Storage and Testing
By Covance Inc.
Product collateral
Covance Central Laboratory Services provides genomic isolation, storage and laboratory testing services to the pharmaceutical industry.
The preparation of pellets with silicified microcrystalline cellulose by ...
By JRS Pharma
White paper
This paper by JRS Pharma LP explains the preparation of pellets with the excipient silicified microcrystalline cellulose (SMCC) by extrusion and spheronization.
Near-infrared analysis of powder moisture in a fluid bed drier
By Bruker Optics Inc.
White paper
This white paper by Bruker Optics Inc. explains near-infrared analysis of powder moisture in a fluid bed drier.
