Exploring EDETEK's R&D Cloud Launch

In this Pharmaceutical Executive video interview, Shakthi Kumar, Chief Strategy and Business Officer, EDETEK, Inc. further explores the company's launch of R&D Cloud, emphasizing the platform's open API access, extensive library of pre-built connectors for various data sources, and real-time data and workflow capabilities.

He highlights key differentiators including the breadth and depth of integrated capabilities (covering the entire clinical trial lifecycle), robust workflow and event management, multi-SSO integration, and a state-of-the-art cloud architecture.

Future development plans include incorporating AI, expanding connectors, and specializing in additional therapeutic areas. Ultimately, the R&D Cloud aims to provide cost reduction, improved business outcomes (faster trials, real-time insights), and enhanced data quality and compliance for clients.

A transcription of the conversation is available below.

The press release emphasizes the R&D Cloud's flexibility and ability to be customized. Can you elaborate on how clients can tailor their R&D Cloud environment to their specific needs and the level of control they have over the selection and integration of third-party software?

In today's rapidly evolving pharmaceutical landscape, the shift from one size fits all products and restrictive platforms to more collaborative ecosystems is truly transmitted, and many of our clients also emphasize the need for best-in-class collaboration and synergistic integration of different capabilities. At EDETEK, we've recognized this through our R&D Cloud, and it's built on two of our flagship platforms. It's eClinical for clinical trial design, execution and management and CONFORM™, which is our clinical data management, aggregation, standardization and regulatory submission.

Clients have full flexibility in terms of selecting the capabilities they desire with either of our two platforms or with third-party software and edit tag provides the data integration and the plumbing, if you may, across the entire ecosystem, and that combined with our multi SSO integration and events driven system orchestration truly provides a very seamless collaboration and workflow, both data and human, across both internal external stakeholders, which we believe is the flexibility that the industry desires right now, and we're very excited about it.

How does the R&D Cloud address potential integration challenges and ensure seamless data flow and interoperability between different software components, both within the EDETEK ecosystem and with third-party solutions?

Our R&D Cloud ecosystem is actually designed on four principles, and this is all keeping in mind the seamless data flow, the interoperability and the seamless orchestration that's desired. The first one is we make it easy for life sciences companies to integrate with various clinical sources. So how do we do this? We do this by providing an extensive library of ready to use connectors. In fact, we have over 80 different data sources that our entire R&D Cloud ecosystem right now is prebuilt, and this includes major EDC systems, central labs, imaging, PV, safety systems and various other clinical sources. All of this is facilitated through our data integration gateway, right so this makes integration much easier. It's prebuilt, and it's also very extensible.

The second one is the data and the human workflow. All of this is in real time. One is the challenges of getting data, but then the question becomes, what do you do with the data? So that has to do with collaboration and workflow, and we provide that in near real time. Our event and Collaboration Hub facilitates that particular functionality.

The third one is we provide public open API access. This is for integration and extension of our capabilities. Because, you know, when life sciences companies want to build their R&D environments, they want to build they want to tailor it, but they can also expand it, you know, working with other different partners, right? And so, the public open API access is a very important component.

The fourth one is extremely important. We call it any data, any source, any format. Our R&D Cloud provides a semantic level standardization of data, and the clients get the flexibility to customize that data models. They customize their structures with zero programming. It's all driven by metadata. And we believe that these design principles, along with a whole bunch of others, actually provides that flexibility for seamless data integration, for seamless, you know, workflow orchestration and truly building an ecosystem for our clients.

What are the key differentiators of the EDETEK R&D Cloud compared to existing cloud-based clinical trial solutions offered by other companies in the market?

We have many key differentiators, but I'll highlight a few. The first is the breadth and depth of our capabilities I talked earlier about our two flagship platforms. Our R&D Cloud comes prebuilt with the entire suite of products for clinic, clinical trial design, execution and management, so systems like CTMS, ETMF, electronic patient reported outcomes, randomization and trial supply management, eConsent and so on. Our R&D Cloud comes prebuilt with these capabilities for clinical trial design and execution.

Once you collect the data, you also need the clinical data management and analytics capabilities that's still delivered through conform. We provide pretty much near time data collection, comprehensive data cleansing, standardization, automated, regulatory, data set generation and sophisticated visualization. And these are kind of like provides the execution part of it, and then what you really do with the data, right and the third level, which we're really excited about is because, you know, it's not just the technology our clients are looking for. They're also looking for domain specialization.

We have launched therapeutic area accelerators. For instance, a couple of months ago, we released ONCO+, which is a clinical trial accelerator just for oncology trials. And so, if you really look at it, it's not only the breadth, but also the depth and the specialization. So that's the first differentiator of the platform.

The second one, which we truly believe provides a very robust set of workflow and collaboration, is that the R&D Cloud. When you actually start building the ecosystems, you have different systems. You have different integration requirements. You have both workflow management and so on. We have an extensive set of capabilities for managing the event and the workflow within the R&D so what happens when a patient is enrolled in a particular site, you know, does it need to trigger off other events in the ecosystem, or when you collect the data, what kind of events does the R&D Cloud need to drive? And so, the event and collaboration workflow is a true differentiator and how it is actually built, because it can not only orchestrate events within our own product suite, but it can also do so for other third-party ones, right? The multi SSO integration extremely important security. Most major pharmaceutical companies, the clinical trials are running globally, and so you need to have the ability to provide that multi SSO integration across different regions, different types of user classes and groups and so on. So that actually comes, you know, pretty prebuilt within the R&D Cloud. So that is the second differentiator.

The third one is the R&D cloud is built on a state-of-the-art cloud architecture, and so there is no tying down the client to a specific environment. It's all there in cloud. I provide scalability, it provides security, reliability, speed of innovation and as well as compliance. So that's we believe makes it easier to incrementally layer our R&D Cloud into existing operating environments. And the fourth one is we provide a very intuitive, interactive visual platform. And the rule that we use is, you know, a user should be able to perform a particular function within two clicks within the entire system. We have taken care through human interface engineering that you know it is easy to use across both you know, specialized users as well as people that you know are using it for review and so on and so forth. So, we do believe that all these differentiators, along with some of the other ones will truly differentiate R&D Cloud today.

Are there future development plans for the R&D Cloud ecosystem?

We have very ambitious development plans for the R&D Cloud ecosystem. We continue to invest in a number of areas, and you know, I can probably highlight a few. We are incorporating advanced, of course, artificial intelligence capabilities within the RNA cloud, specifically agentic AI and machine learning technologies to drive better insights and decision making for our clients. So that's something that's ongoing.

The second one is we are expanding the list of upstream and downstream connectors. This is to make it easy to integrate our R&D Cloud, with other third-party software, and we expect to continue to partner with others. For us partnership is a key tenet of what we want to do, so we will continue to do that. And we will double down and specialize in other therapeutic areas as well. I talked about on cop loss, but next in the line, we're working on CNS and that immunology. So, I think we do believe that that provides, you know, significant benefits to the industry, you know, getting much needed therapies faster to patients. And so those are some of the areas we're looking at right now.

How does the R&D Cloud translate into tangible benefits for EDETEK's clients?

Tangibility comes in three different ways. The first one is the best metric for tangibility is cost reduction, so they can incrementally layer our R&D Cloud offering in. To existing operational environments where there are gaps to really build an ecosystem. So, there is no need to replace an expensive, lift and shift of their existing environments, as well as costly integrations, because our on the cloud already comes prebuilt with over 80 different integrations with major software, so cost reduction is one.

The second one is in terms of business outcomes. We do believe it has significantly helped our clients to improve the speed and efficiency of clinical trial execution. Miranda, just to give you an overview today, our platform is used by over 100 Life Sciences organizations. We have our conform platform. And eClinical platforms have managed over 3 billion data points, including many, many mega trials. In terms of business outcomes, we're very confident in driving faster study start up, as well as real time data insights and accelerated regulatory submissions, right? So that's kind of driving business outcomes. Is a key benefit to our clients.

The third one is improved data quality and compliance. The platform, we have robust, you know, validation rules, we have alerts as well as a whole library of checks that we perform on the data that's ingested into the R&D Cloud, which means that the data quality improves, as well as compliance to various regulatory standards, right? Those are kind of three tangible benefits, as I mentioned earlier, we are really excited for our clients that the dream of build your own R&D Cloud is actually becoming a reality, and we here to support it.