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CellPort Connect - CC 109: CROs, CDMOs, and Outsourcing

We have many customers who are doing research, or development, or manufacturing focus on one particular area. We have other customers like CROs, CMOs, CDMOs who are doing work on behalf of other people from the perspective of compliance and reporting. How do you see those differing between the CRO, CMO, CDMO and people who are not focused on performing those activities for others?

Yeah, I think in today's world, companies starting out, even the, the big guys and the little guys, the CRO and CDMO model is what they're going to rely on. It becomes a variable cost if I'm doing research up front and I'm a biotech company and I don't move too far forward because my research is stalled. I don't worry about having to hire a staff that can do a bunch of different ancillary tests. You outsource everything today that's been well established, but when you do outsource, there's an expectation that the operation has both the scientific expertise and the operational expertise to do and perform whatever you've asked them to do and that's at the research level, that's at the development level, that is at the manufacturing level. The issues of traceability of a project and reproducibility become even more complex when they're out of your control, so to assure your customers that things are under control and that your processes are in place. Digitalization is the next sort of generation that the process can be quickly reviewed and analyzed and and essentially audited even at the research level to show that all of these things have happened. That the results are strong and it makes every, it makes the aspects more visible, so the confidence for the person purchasing the services goes up as a by product of that too is that your operation becomes more efficient in what you do, so the the the overall process by digitizing and making sure things are visible and I know what happened. I can look at the traceability over time is probably greater today for the CROs, the CDMOs than ever before and as we've said, I in, in prior discussions today, the interoperability of scientists and the difficulty in hiring people that are qualified necessitates that the CROs when they get a big contract, when need to staff up can on board people quickly and digitalize process. A digitalized lab allows them to do that these factors and the need for the client to be assured that whoever they place their work with is scientifically capable and operationally efficient is a real differentiator and it is sort of the minimum that I think CROs and CDMOs should aspire to, with regard to that with regard to assurances and security.

We haven't really talked about the, the topic of information security that has to do with things like ISO 27,001 certification to ensure that the information is being held to the highest standards. Things like 21 CFR part 11 or Annex 11 Compliance for electronic signatures and electronic witnessing, things like the ability to have it all in a secure cloud computing platform like Microsoft Azure, which CellPort is, is hosted in. Those are all things that I think underscore the information security concerns of our customers in general, but of our CDMO and CRO customers in particular. Yes and, and with the multitude of customers that a lot of these companies have, the story is the same, you get selected partly on your expertise on your turnaround time,

but the assurances that when I'm working with the CRO or CDMO, my work is protected and that's again, not only just the differentiating point for the CROs and the CDMOs, but also an operating sort of qualification for themselves where you tout this, it's it's something that you share with your clients and they benefit from because you've gone through the processes of doing that in today's world. We watch the evolution of server based internal systems to SaaS products and CellPort is a SaaS product. What are the concerns, what are the compliance issues that clients have expressed to you, and what is the standard at which CellPort wants to operate?

Customers have expressed the concern that their data are held to the highest security standards. We've addressed that issue by undergoing an ISO 27001 certification. That process puts us at the highest level. In addition, Microsoft Azure is the foundation for our cloud computing platform. Which is also at a very high level. Every electronic signature in CellPort is 21 CFR part 11 compliant annex 11 compliant. We've gone to great lengths to ensure that we're holding our customers data to the very highest standards. When a customer implements CellPort, they should expect to see a few things. They should expect to see an immediate increase in productivity. They should expect to see an immediate decrease in the amount of manual documentation. They should see quality control costs go down. They should see happiness go up.

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