If a CRO is Managing My Clinical Trial Data, What are My Validation Responsibilities?

If you have a Contract Research Organization (CRO) that is managing and hosting your content and you're accessing their content management solution. The responsibility is on the CRO to have a validated compliance content management solution for your content. However, you have to do due diligence and close your vendor auditing practices, as well as your vendor management processes, and your SLA with your CRO to ensure that you've done proper due diligence to make sure that they are properly managing your content. The burden is effectively on the CRO, however you have to do your due diligence to ensure that you're auditing them appropriately out of their system validation materials, as well as making sure that the processes and procedures are up to par for managing content.

The USDM Life Sciences Clinical Services and Solutions team provides our clients (from start-up Biotech to large Pharma/Device) with the latest technology, processes and strategies to assist with efficiency, quality and compliance in any scenario and offers our clients a cost-effective, proactive and unified partnership in goal achievement.

What are the Costs, Elements, and Approximate Timeline to Implement a Compliant Field Service Solution?

It really depends on how many users you're looking at and some of the complexities with your environment and requirements. As far as line items, you're going to be looking at the field service application licensing. We have to get the application into our environment -- into the user's hands. How many people do we have? That is going to be one dollar amount.

Then you've got the implementation services. Those, you can imagine, vary quite a bit depending on, again, the size of your service organization and some of the various requirements that you have with your different field service processes. Those implementation services are also going to include the initial validation that we would perform. Again, it's all one professional service number. Then, you've got the subscription for the ongoing validation documentation that USDM provides with each seasonal release. Those are the ways we would just provide a high level breakout for the different costs involved.

As far as the timeline, what we're seeing out there is an average of 3 to 6 months to implement a validated field service application. Again, the timelines can go up or down based on a couple of things. Most often it's around data migration. How much data are we starting with? Do you have years and years of field service history that we need to bring in and make that available within ServiceMax. If yes, that's just going to take a little bit more time.

Also integration. ServiceMax is built on a platform which is extremely open, and it's not hard to tie in to other systems like your ERP, a complaint management system. But, it's just those things need to be thought about and brought into the project. You can, like I said, depending on the complexity, either lower that amount of time or extend it out a little bit.

The USDM Life Sciences Cloud Team is the one you can trust when looking to move applications and business processes to the Cloud. Our team of cloud experts understand compliance, validation, implementation, mobile, data security, data migration, and system integration, and we ensure that leading cloud vendors meet and maintain compliance regulations around the globe.

What is the Recommended Approach for Control on Non-Regulated Laboratory Instrumentation?

Michael Ambrose, Vice President of Lab Services and Solutions at USDM Life Sciences says his approach would be for a calibration or a qualification. For instance, if it's a basic instrument, he’d still want to calibrate it. He would still want to have a set of requirements to say what the calibrations test points and ranges should be and make sure that that system is producing data that I could consider valid, even if it's not going into a regulatory document or submission. The same with qualification. He would definitely have manufacturer's specifications being met before I installed an instrument and the analogy I use often is a librarian is going to want to get their books back if they're using a software to track it. They're going to want to do some type of testing, make sure the software works, make sure it's installed properly and that would go for any of the basic laboratory equipment. The place he would maybe change if it wasn't validated, if it wasn't regulated, would be a validated system.

Ambrose says he might not do the extent of extra documentation, but would certainly have requirements and testing around any software that was used in a lab just for data integrity and data security reasons.

USDM Life Sciences offers a complete suite of laboratory enterprise validation and compliance services led by a core team of highly qualified, scientifically trained laboratory instrument/systems specialists.