Speaking of cloud, the relevant question today is not whether someone should adopt it or not. They must if they want to thrive. The question to ponder upon is which solution or service provider to choose from amongst the countless ones. There indeed are a lot of IT companies that provide robust cloud environments, but the life sciences is not a sector where just being ‘robust’ ticks all the checkboxes. There are strict regulatory compliances to be met at all times, and they frequently change. Based in Springfield, Court Square Group is one of the very few companies that understand the life sciences world from a perspective of qualified and validated applications. This managed services company provides an Audit Ready Compliant Cloud ARCC) infrastructure for hosting electronic document management systems, eCTDs, and FDA gateway applications, along with qualified and validated disaster recovery and long-term archiving.
We confabulated with Keith Parent (Founder and CEO of Court Square Group) to get a more detailed picture.
1. Introduce us to Court Square Group and where does it fit into the vast life sciences landscape.
I started the business back in 1995 and worked with Pfizer to manage about 6000 of their machines all over the world. That has been a crucial experience which significantly adds to the
market expertise we have now. Our enterprise-class solutions are mainly targeted at the midmarket. We are specialists in helping customers put qualified document management
systems and other related applications in place.
In the life sciences sector, companies while moving into the cloud need to ensure that the cloud environment is qualified and they have proper control of the environment. We call it an Audit Ready Cloud Environment. The applications that are put into that environment also need to be validated so that the data they produce are safe for regulatory (FDA in our case) submissions. Life Science companies have many phases of drug or medical device development and typically shifting from pre-clinical to the clinical phase will drive a series of regulatory burdens that most companies either don’t have the staff for or don’t know how to integrate it with a cloud approach. That is where we come in by helping them to not only transition from a non-qualified environment to qualified environments but also to qualified environments in the cloud. We enable our clients to show control over their environments which isn’t always the case with cloud vendors.
We work with multiple software vendors to host their applications on our ARCC suite. Our customers don’t have to worry about anything. We take all the strain out of qualifying an environment so that life science companies can leverage it to use validated applications without worrying or risking a letter from the FDA. That’s what we commit. We ensure that all of the things are done properly and that our clients or software partners that we host are audit ready.
2. What are qualified environments and how are they vital?
Qualified environments are those wherein you put the systems together and explicitly define what are you going to create and how are you going to do it. Then, from a documentation perspective, you ensure you have all the artifacts to prove that what you have built is exactly what you planned for. From an audit perspective, when FDA auditors look at it, they can see that we have qualified everything in a base level system and those systems can be used to hold validated applications. They also look to make sure that the staff is trained in maintaining control over the environment and that’s not always the case with some of the cloud vendors. Most companies have skilled technical people but they may not be familiar with all of the FDA regulations necessary to work in a cloud environment and still maintain the regulatory posture
3. Tell us more about your managed services capability.
Apart from the ARCC suite, we have two more offerings— validated disaster recovery and long-term archiving. In addition to validated applications, enterprises also need disaster recovery applications. However, oftentimes, they don’t realize that they need to validate the recovery of that system as well. Our validated disaster recovery suite is an out-of-the-box solution for such cases. Next is a long-term archiving product that stores submissions to the FDA in the original PDF format, as well as the formats amended to them. If the FDA comes back and demands to look at the data, say 20 years from now, we will convert it to a suitable format that is readable.
4. What does a typical Court Square Group-customer engagement look like?
Sometimes, we get customers through our software partners— the enterprises that have bought or licensed software from our partners. We work with these customers’ network and quality teams and review all their documentation; we get signoff on the configurations that we set up, and all along the way we generate the artifacts to keep that environment qualified. And when they install an application, we can help them validate that application. From that point
forward, it is our job as the hosting and managed service provider to maintain the qualified state of the infrastructure as well as the validated state of that application.
In other cases, customers come to us with their own environment which they contract us to qualify, or with validated applications about which they are not sure.
5. Please share an instance where Court Square’s team assisted clients to overcome compliance challenges.
Sometimes I have a client that wanted to extract clinical voice files from their database.
They had an innovation that would help in clinical trials, but it wasn’t 21 CFR Part 11 compliant. Court Square’s team was able to put an infrastructure around their project and add voice files
into our environment for audit logging and provide the features necessary for 21 CFR Part 11 compliance. We also enabled them to set up multiple sites across the country that could allocate resources for each of the users, both the clinician and the patient, and create an overall portal site so that all of their clinicians can look at different trials. Right now we are in the middle of a project where we are helping a customer build their regulatory capabilities. We are developing an IT as well as a regulatory roadmap that the client
can submit to the FDA.
6. What is brewing inside your innovation lab?
We have a number of new offerings and are working with partners to roll out advanced solutions. We have partnered with some CROs and Consulting companies to develop a consistent methodology for rolling out 21CFR part 11 compliant projects. We are also collaborating with the Drug Information Association (DIA) and Regulatory Affairs Professionals Society (RAPS) to help drive new standards across the industry.