spacer
home > white papers > Key to Outsourcing Method Development and Validation A Pragmatic Approach - RSSL
WHITE PAPERS
logo_RSSL.jpg

RSSL

phone +44 (0)118 918 4024
web http://www.rssl.com
email University of Reading, Whiteknights Rd, Reading, West Berkshire RG6 6LA

Key to Outsourcing Method Development and Validation A Pragmatic Approach

In an industry that is seeing an increasing level of work being outsourced, the Contract Research Organisation (CRO) of choice needs to have proven experience in both the pragmatism and flexibility of the method developerís mind set and a regulatory background in validation.
spacer

Member login

E-mail address:

Password:
Remember me


News and Press Releases

FlyPharma

FlyPharma Conferences and Pharma.Aero are joining together to support a collaborative platform for forward-thinking pharma and cargo professionals at this yearís FlyPharma Conference Europe, with a view to discussing key pharma supply chain challenges affecting all stakeholders.
More info >>


White Papers

Recommendations for Implementing Assessment Criteria Guidelines in Lymphoma and Chronic Lymphocytic Leukemia Clinical Trials

Perceptive Informatics

Standardized assessment criteria are becoming increasingly important in obtaining valid outcomes in oncology clinical trials. While standardized criteria encourage a more uniform approach to assessing clinical trial data, they are often subject to the interpretation of the user. These differences in interpretation, while seemingly minor, can have a major impact on assessments. The most commonly used standardized criteria for lymphoma have been no exception. Differences such as minimum new lesion size, lymph node normalization size requirements, inclusion of extranodal lesions and assessment of organomegaly can have a profound effect on overall response. Additionally, heightened scrutiny of the assessment criteria used in a given protocol can lead to questions about a drugís efficacy if not applied correctly according to regulatorsí interpretation.
More info >>


Industry Events

PREP 2018: 31st International Symposium and Exhibit on Preparative and Process Chromatography

8-11 July 2018, Hyatt Regency in the Baltimore Inner Harbor, MD, USA

The PREP series of symposia is the most recognized international conference devoted to advances in separation technologies in the field of preparative and process chromatography. Join us for a dynamic and innovative program where experts from around the world will address the latest developments and hottest topics in preparative and process chromatography.
More info >>


©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement