Validation services

54 Results

Local lab Data Management

Local lab Data Management

Content provided by 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

Content provided by Frontage Laboratories | 01-Oct-2019 | 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

Content provided by 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

Content provided by Merge eClinical | 01-Apr-2015 | 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

Content provided by 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

Content provided by Almac Group | 04-Aug-2014 | White Paper

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

Customs Warehouses Benefit Clinical Trial Supply Chain

Customs Warehouses Benefit Clinical Trial Supply Chain

Content provided by Marken | 11-Jun-2014 | White Paper

Marken’s new customs-bonded warehouse within the Marken depot in Frankfurt, Germany allows Marken to store pharmaceuticals with an origin outside the European...

Butterworth

Elemental Impurity Analysis in Pharmaceuticals

Content provided by Butterworth | 06-May-2014 | 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...

Controlled Release and Bioavailability Enhancement

Controlled Release and Bioavailability Enhancement

Content provided by 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?

Content provided by SGS Life Science Services | 26-Mar-2013 | 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

Content provided by 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

Content provided by SGS Life Science Services | 03-Sep-2012 | 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

Content provided by SGS Life Science Services | 09-Jul-2012 | 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

Content provided by SGS Life Science Services | 27-Feb-2012 | 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

Content provided by SGS Life Science Services | 22-Feb-2012 | 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

Content provided by SGS Life Science Services | 24-Jan-2012 | 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

Content provided by SGS Life Science Services | 06-Dec-2011 | 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

Content provided by SGS Life Science Services | 07-Nov-2011 | 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

Content provided by SGS Life Science Services | 26-Sep-2011 | 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

Content provided by SGS Life Science Services | 30-May-2011 | 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

Content provided by CDC Software | 17-Aug-2010 | 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

Content provided by William Reed | 02-Aug-2010 | 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

Content provided by William Reed | 24-Mar-2010 | 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...

Understanding The 505(b)(2) Approval Pathway

Understanding The 505(b)(2) Approval Pathway

Content provided by Camargo Pharmaceutical Services | 27-Jan-2010 | Product Brochure

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...