SALSA (Statistical Assessment Layer for Site Audits) is a statistical tool and a smart solution for your QA activities, specifically auditing and although meant to be used on a routine basis, it is particularly useful in these trying times with Covid-19 and your resulting auditing issues. It enables upfront analysis of your study data and optimises sampling intelligence by enabling sound decisions to be made regarding site selection, subject selection and choosing data points, for audit. Whether on-site or Remote Investigator Site Audits (RISA), you are able to identify unusual data patterns and statistical abnormalities in different subject populations and identify subject outliers or data point outliers. SALSA can also aid stepwise RISA where a full remote audit is not possible, necessary or wanted and with or without site/CRO staff involvement or where just a data review is to be carried out. SALSA can also help you look at ongoing site compliance and quality status monitoring and help you to address your data issues identified at any point in time during study conduct or at the end of your trial and facilitates an effectiveness check for your CAPAs after inspection or audit.
At the recent launch of SALSA, The Engaged Database GmbH (sister company of GXP Engaged Auditing Services GmbH), Managing Director, Dr Barbara Heumann, said, “It has always been our aim to support our clients with the challenges that they face ensuring the compliance of their R&D programmes. SALSA is an extremely effective tool to address and overcome the industry’s most burning challenges, which put an increasing pressure on our valued sponsors to make the correct decisions made on the most robust grounds".
Why SALSA? As it answers all your questions!
Please do download our SALSA Concept Paper and our document Risk-Based Approach to Auditing Implementing RISA and SALSA.