Novartis goes digital with FocalView for ophthalmology clinical trials

May you live in interesting times… A colleague flagged this for me. I’ll be very interested in the particulars of how this all works going forward. #ItsAllAboutApps

 

~TJK

Source: Novartis goes digital with FocalView for ophthalmology clinical trials

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Applying the “Risk-based Approach to the Quality Review

Although the concept of “Risk Based Approach” is not new to Validation, it is not often applied to the Quality Review for a Validation project. With the realities of increased volume of validation work and finite QA resources, it makes sense to target the Quality Review on the areas of most significance. I’ve mocked up this frame work to do exactly that. Any thoughts?

~TJK

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Targeted, Risk-based CSV Operational Quality (QA) Review

Request for Quality Review: The Validation Team (Business/Technical/Validation unit provides the list of deliverables to be generated for a given project in conjunction with the request for Quality Unit Review for the project.

The Quality Impact Assessment is conducted independently by the Quality Unit to determine the level of review required for a given Validation project. The Quality Unit will review and sign the Risk Assessment.

There will be an Internal Escalation Process to the QA review triggered by various flags or issues (e.g., request from stakeholders, problems detected during review, etc.) that can potentially increase the level of Quality Review within a project.

Quality Impact Assessment	Targeted QA Review	QA Approvals	Example Scenario
Critical	All deliverables; 100% Review	Risk Assessment, Plan, Report	Directed; GMP LIMS for Release
High	Risk Assessment, Plan, User Requirements, Report, Sampling of Scripts (e.g., SQ N+1)	Risk Assessment, Plan, Report	PVDB; Clinical DB; Primary GLP Data System (e.g., SDMS)
Medium	Risk Assessment, Plan, Report	Risk Assessment, Plan, Report	Clinical Trial Management System (Monitoring), Laboratory Data Generating System
Low	Risk Assessment	Risk Assessment	Indirect GxP System (e.g., Learning Management System)

SQA Abstract 2 – Building a Better Way

And here’s the second abstract I submitted. This one is with colleagues from Data Management and Systems Validation (IT). It should be a really good session. Again, fingers crossed.

~TJK

Building a Better Way: The Evolution of eDC/Clinical Database Validation Processes

The power and real-time feedback made possible by implementing “eDC”/eCRF systems makes them indispensable to Clinical Research. However, the Data Management groups that typically own these systems often struggle with the appropriate way to implement and validate them; and then struggle in their attempts to appropriately validate the study-specific databases that they build within them. There are many reasons for this including: cGMP-centric concepts and terminology associated with validation, inflexible/inscalable validation methodologies, Data Management groups often being “semi-technical” in expertise-level, the dual role Data Management has in terms of being both Developers and Users of the system, etc. By partnering with the right resources and using the right tools, a Data Management group can move to a more dynamic validation paradigm with processes that make their validation more meaningful, their testing more robust, and their timelines shorter.

I. From the QA Perspective: This session will identify the challenges encountered in the implementation of eDC, the tools and ad hoc methodologies that were used, the processes that were developed, and the evolving role of QA moving from “a police” role, to a “partner” role, and ultimately to a fully independent role in which QA audits a process in which they are not involved day to day.

II. From the IT Validation Perspective: This session covers the challenges of providing validation services to a GCP-regulated area, the importance of understanding the more dynamic nature of Clinical Research as contrasted to the cGMP/GLP environments with which most Validation Engineers are familiar, methods for evaluating, adapting, and supplementing a vendor’s “canned scripts”, the importance of managing external vendors who are conducting testing on behalf of the Validation Manager.

III. From the Data Management Perspective: This session explores the challenges experienced by a Data Management/Programming group while moving from a “The Vendor builds our trials” model to a “We build our own “eDC” trials. We will share our journey through the frustration of finding that none of the Validation tools/templates that were available met the needs of our DM (and Client) groups, through working with our IT, ClinOps, and QA partners to build the tools we need, through reluctant skepticism regarding timelines, and ultimately to a point where the process is both improving our output and shortening our timelines.

A new position

I’ve been quiet over the past couple of weeks because I’ve been tremendously busy. This is my last full week here at sanofi-aventis. I have accepted a new position with another pharmaceutical company and am trying to closeout all open items. 

I am both excited about the new position (which is a QA Validation position supporting Clinical Research) and sad to be leaving my current position. I’ve had the privilege to work with a great team of people here whom I will miss greatly. Still, ours is a small industry. This likely won’t be “goodbye”, but rather “goodbye for now”.

 I will get back to more frequent posting once I have cleaned my proverbial “plate”.

~TJK