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Pharm-Olam’s Audit-Ready Approach to Database Build

By Renee Breiten
On August 31, 2020

Pharm-Olam is committed to following our industry’s best practices – sometimes even those from other segments of our industry. In 2015, Pharm-Olam Data Management adopted a “GLP” or Green Light Process documentation verification strategy. This methodology is typically used by Site Startup Teams to confirm each site’s readiness to enroll subjects in a clinical trial. Pharm-Olam’s Data Management team applies this rigorous GLP self-audit across every single database deployment, mid-study database update, and database lock because it helps us adopt an audit-ready focus.

By using this unique application of GLP, our Sponsors can be confident that all database build or lock documentation can be readily produced for any auditor during the course of a study or years later, after the final Clinical Study Report (CSR).

Traditionally, the clinical research industry’s approach to Data Management is to audit the eTMF and correct any errors, but database GLP ensures our organization is always audit-ready and compliant with Good Clinical Practice (GCP) 100% of the time. In this article, we will explain how Pharm-Olam applies Data Management GLP and catch up with Sharon Powell, Vice President, Biometrics, on the subject.

To begin, let’s start by answering the question, “What is GLP?”.

 

What is GLP?

GLP stands for Green Light Process. The basic concept is that there must be clear documentation in place before the trial can be “green-lighted” to the next phase. For example, all informed consents must be manually verified before a study can begin. This verification has to include evidence that the materials were checked, including any versions, who reviewed the documents, and when they were examined. At Pharm-Olam, we take this a step further and use an independent reviewer to check our documentation so that every step in the process is beyond reproach and subjectivity.

“GLP makes my team confident we will do beautifully during any audit, whether internal, Sponsor-originated, or coming from a regulatory authority because all of our database documentation has been verified per SOP by a Pharm-Olam Independent Reviewer.” – Sharon Powell

 

Understanding Our Quality Focus

Our organization works hard to be more than just operationally sound. We work to eliminate errors, and we strive for perfection in everything we do. Introducing stringent GLP checkpoints throughout our Data Management process makes a lot of sense. We apply GLP anytime we have a database go-live, implement mid-study major database updates, and lock a database – and there are no exceptions. To achieve this, Pharm-Olam’s DM management team went back through Standard Operating Procedures (SOPs) and created two detailed checklists (Database Move to Production and Database Lock) to be used by Independent Auditors. This Independent Auditor is not a part of the study team in any capacity and has no personal stake in the study or its outcome. The Auditor addresses each GLP from an objective standpoint and requires precise document creation, execution, and filing. Otherwise, the GLP is not approved, and the process starts all over again.

“We always had a good team who followed SOPs, but under intense pressure and aggressive timelines, it can be easy to stretch boundaries, by not checking all the boxes,” explains Powell. “For example, a Go-Live email approval with a 😉 doesn’t work; it has to be a formal signature and approval.”

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GLP precludes all “exceptions” by introducing a single measure of success. Pharm-Olam conducts GLP when a database moves to production and database lock, so every piece of information is accounted for before the study progresses to the next level or stage of the trial.

 

Data Management Success with GLP

“Over the past five years, we have had 100% accountability,” says Powell. “Our team has had zero database audit findings with FDA, MHRA, or EMA.”

GLP illustrates how Pharm-Olam is taking data integrity seriously. “Clients read our SOPs. GLP is part of a Working Instruction,” explains Powell. “Clients like it because it shows we take our job seriously, and we are truly managing their study using the highest standard of GCP guidance. I don’t know of any other CRO that does this – everyone just assumes documentation miraculously appears – but we don’t wait for an auditor to find a mistake. Subject data is critical for Pharm-Olam to help people live better lives. Zero findings is our protocol. Every study, every time.”

 

The Pharm-Olam Difference

Pharm-Olam takes Data Management seriously. By checking our processes and information at each step with GLP checkpoints, we can effectively eliminate errors. That’s good for our Sponsors because the data is cleaner, it is good for us because we don’t waste time and resources repeating work, and it is good for our subjects by making their data count.

 

Helpful Resources:

Pharm-Olam Data Management Service Overview

6 Tools Used To Achieve a Clean & Reliable Database Lock

Tags: Data Management

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