Validation services

55 Results

Local lab Data Management

Local lab Data Management

Q² Solutions | 01-May-2020 | Data Sheet

When a clinical trial requires local or point-of-care laboratory testing, managing the resulting data can be a significant burden to both the sponsor and...

Validating The Simoa Technology

Validating The Simoa Technology

Frontage Laboratories | 01-Oct-2019 | Technical / White Paper

Frontage is the first and only laboratory to validate Quanterix’ Simoa HD1 Analyzer for performing immunoassays. Most of the advanced instruments used...

Ajinomoto-logo

The Power to Make, A Virtual Tour

Althea | 24-Mar-2017

You have the power to make a difference. To make new therapeutics that improve quality of life and inspire a healthier world. To do this, you need a manufacturing...

How Sponsors and CROs Benefit From EDC Efficiencies

How Sponsors and CROs Benefit From EDC Efficiencies

Merge eClinical | 01-Apr-2015 | Technical / White Paper

Intense competition in the prescription drug market is driving pharmaceutical companies to expedite their drug discovery and development processes. Pharmaceutical...

Developing a Good Plan B

Developing a Good Plan B

World Courier | 01-Sep-2014 | Best Practice

World Courier is continuously looking out for trouble on a local and global scale.  Areas of conflict that might affect transport routes? A hurricane?...

Temperature-Controlled IMP Distribution Challenges

Temperature-Controlled IMP Distribution Challenges

Almac Group | 04-Aug-2014 | Technical / White Paper

UNDERSTANDING THE CHALLENGES OF TEMPERATURE CONTROLLED INVESTIGATIONAL MEDICINAL PRODUCT DISTRIBUTION IN EMERGING MARKETSTemperature deviation within the...

Butterworth

Elemental Impurity Analysis in Pharmaceuticals

Butterworth | 06-May-2014 | Technical / White Paper

A method to identify the presence of heavy metals in pharmaceuticals was introduced in the United States Pharmacopoeia more than 100 years ago. Today pharmaceutical...

Vetter Pharma

Meeting the challenges of complex drug substances

Vetter Pharma International GmbH | 15-Apr-2014 | Technical / White Paper

Realizing the full potential of an injectable drug compound is no small task. In the months and years that lead from the discovery phase to the rigorous...

Controlled Release and Bioavailability Enhancement

Controlled Release and Bioavailability Enhancement

Information not available | 28-Oct-2013 | Case Study

Metrics provides product development that leverages proprietary pharmaceutical technologies in the areas of: •    Customized Controlled Release Drug Delivery...

White Paper: Is My Method Still Valid?

White Paper: Is My Method Still Valid?

SGS Life Science Services | 26-Mar-2013 | Technical / White Paper

The goal of method validation is to pro­vide proof that data from each individual sample is indicative of the actual batch content with little deviation....

Extractables & Leachables Risk Assessment

Extractables & Leachables Risk Assessment

SGS Life Science Services | 22-Oct-2012 | Case Study

An extractables and leachables case study describes how a comprehensive risk assessment was performed across the entire production process of a European...

New Early Phase Concepts: Practical Implementation

New Early Phase Concepts: Practical Implementation

SGS Life Science Services | 03-Sep-2012 | Technical / White Paper

There is an urgent need to use innovative techniques in early development. This paper will discuss several case studies in which new clinical trial methods...

Vaccine-Based Clinical Trials

Vaccine-Based Clinical Trials

SGS Life Science Services | 09-Jul-2012 | Technical / White Paper

Download this paper to read two case studies which illustrate strategies for planning and implementing a vaccine-based infectious disease clinical trial...

Sample Prep Proposed USP<233> Elemental Impurities

Sample Prep Proposed USP<233> Elemental Impurities

SGS Life Science Services | 27-Feb-2012 | Technical / White Paper

Proper sample preparation is crucial when analyzing for trace metals using inductively coupled plasma (ICP). This paper illustrates how solubility of the...

How to Approach Identification of Anomalous Peaks

How to Approach Identification of Anomalous Peaks

SGS Life Science Services | 22-Feb-2012 | Technical / White Paper

The sudden appearance of an unknown peak during an HPLC analysis of a pharmaceutical product can be a critical finding causing delays and requiring considerable...

New Challenges in Early Clinical Development

New Challenges in Early Clinical Development

SGS Life Science Services | 24-Jan-2012 | Technical / White Paper

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...

Glycosylation of Proteins: Structure & Analysis

Glycosylation of Proteins: Structure & Analysis

SGS Life Science Services | 06-Dec-2011 | Technical / White Paper

Glycosylation is one of the most widely observed, and structurally diverse, forms of post-translational modification of proteins and glycans have been...

Improving Signal Detection in Drug Safety

Improving Signal Detection in Drug Safety

SGS Life Science Services | 07-Nov-2011 | Technical / White Paper

Early identification and management of emerging drug safety issues are a major concern of industry stakeholders. Electronic capture systems for AE reporting...

White Paper: Vaccine-Based Clinical Trials

White Paper: Vaccine-Based Clinical Trials

SGS Life Science Services | 26-Sep-2011 | Technical / White Paper

Download this paper to read two case studies which illustrate strategies for planning and implanting a vaccine-based infectious disease clinical trial...

Protein & Glycoprotein Characterization by MS

Protein & Glycoprotein Characterization by MS

SGS Life Science Services | 30-May-2011 | Technical / White Paper

This paper gives the essential background to understanding biopharmaceutical characterization by mass spectrometry and its importance in accelerating the...

Beyond Plant Visibility to Business Improvement

Beyond Plant Visibility to Business Improvement

CDC Software | 17-Aug-2010 | Technical / White Paper

Increasing evidence is pointing to the realization that many plant-wide intelligence initiatives do not lead to the dramatic improvements that the business...

Generate Sales Leads: Free White Paper

Generate Sales Leads: Free White Paper

William Reed | 02-Aug-2010 | Technical / White Paper

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...

Generate sales leads with a good white paper

Generate sales leads with a good white paper

William Reed | 24-Mar-2010 | Technical / White Paper

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...