Validation services

Assessing Pre-Existing Antibodies in Biotheraputic Development

Frontage Laboratories | 21-Aug-2019 | Technical / White Paper

Immunogenicity is the leading reason that biologics fail in clinical trials, and thus it has become imperative for drug development programs to include...

The Truth about Physician Referrals and Clinical Trials

Despite growing evidence, the myth that physicians won’t refer patients to clinical trials persists, perpetuated by the belief that they fear losing their...

Survey Report: State of the global pharmaceutical contract services industry 2018

William Reed | 11-Jul-2018 | Research Study

In May 2018 Outsourcing-Pharma.com, in association with InnovoCommerce, conducted its second annual ‘state of the industry’ survey on its user base of...

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...

Cleaning Validation - What do you need to consider to ensure a successful outcome?

RSSL | 14-Jun-2016 | Technical / White Paper

The data used to determine the success of a cleaning validation is built upon both the effective evaluation of the manufacturing plant and the robustness...

Elemental Impurity Analysis in Pharmaceuticals – The Road To Implementation of ICH Q3D

Butterworth | 26-May-2016 | Technical / White Paper

The International Conference of Harmonisation (ICH) guidance document on elemental impurities, Q3D, reached step 4 in December 2014, meaning the final...

Enhanced Sampling and Calibration Procedures for the Analysis of Residual Oxygen in Nitrogen Purged Pharmaceutical Packaging by GC-TCD

Butterworth | 24-Sep-2015 | Technical / White Paper

The classic Modified Atmosphere Packaging (MAP) application, in the pharmaceutical industry, uses medical grade nitrogen to purge atmospheric oxygen and...

Discover the benefits of collaborating with your central lab partner early in protocol development

ACM Global Central Laboratory | 19-May-2015 | Clinical Study

Until recently, sponsors and CROs engaged their central laboratory simply for routine safety testing. However, as clinical trial protocols have grown in...

Enhanced Residual Solvents Analysis: A Practical Approach to Sampling, Delivery, Storage and Analysis.

Butterworth | 12-May-2015 | Technical / White Paper

Samplestorage, handling anddelivery are as important in the determination of residual solvents as the analysis itself. This paper provides practical advice...

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...