Adaptive Clinical Systems
Decentralizing Clinical Trials Through True Data Interoperability

The COVID-19 pandemic was a catalyst for implementing decentralized clinical trials (DCTs) enabled by digital health technologies that can enhance patient access and diversity, drive down costs, shrink time frames, and bring technology to the patient.

With the FDA’s recent guidance on DCTs, many eClinical platforms are often under-equipped to manage these varying elements holistically, resulting in complex workflows between systems, inefficiently patched solutions powered by disparate tools, and the inability to effectively handle emerging data sources.

Bridging this gap is Adaptive Clinical Systems, which helps CROs, sponsors, and pharma companies proactively eliminate issues related to high-volume DCTs and establish easy interoperability of disparate data through its Adaptive eClinical Bus.

Creating Cohesiveness in Clinical Trials

Typically, sponsors and CROs use different vendors for clinical data management systems (CDMS), clinical trial management systems (CTMS), electronic data capture (EDC) systems, randomization and trial supply management (RTSM) systems, and eCOA/ePRO (electronic outcome assessment /electronic patient-reported outcome) systems.

This segmented approach is usually driven by a vision to create a best-of-breed suite of eClinical tools in the clinical research environment. Despite having a productive goal, clinical operations teams seldom achieve it because limited interoperability across disparate tools often leads to duplication and errors that drive delays.

Flipping this script, the Adaptive eClinical Bus leverages its vendor-agnostic nature to aid clients in making healthy partnerships with many companies regardless of their choice of technology partner.

“With the rising prevalence of IoT in DCTs, clinical trial managers are inundated with clinical data that sits in disparate systems. With the Adaptive Clinical Systems’ extensive library of interconnects, we bring the necessary data together for meaningful insights quickly,” says SinaAdibi, CEO of Adaptive Clinical Systems.
Intelligent middleware enables proprietary and third-party eClinical systems to interoperate seamlessly, boosting data entry, verification, harmonization, aggregation, and visualization processes to help save significant time and resources.

Above all, the Adaptive eClinical Bus provides bi-directional data flows and real-time visibility from any eClinical tool, including EDC, eCOA, CTMS, EHR, Medical Imaging, IRT, etc. wearables, RWD, and analytics/data visualization systems.

Enhancing Innovation for Veeva Implementations

Since its inception, Adaptive Clinical Systems has been focused on delivering true data interoperability for clinical trial research. The Adaptive eClinical Bus eliminates fragmented data flows and improves information management. The middleware’s intelligence engine determines the best-suited data mapping techniques for better interoperability across every data point. It also has plug-and-play modules that quickly work along with eClinical systems and transform inefficient data flows.

“Our Adaptivee Clinical Bus brings order to the chaos caused by data fragmentation by reliably integrating a client’s technology into an interoperable, efficient, and accurate clinical trials system,” says Adibi.

“Since our beginning, we have focused on interoperability from our first assignment moving EMR into EDC to today’s more complex data fabrics.”

A critical part of every clinical trial is proving data integrity to the FDA. For example, antiquated and time-consuming practices such as “source data verification” are eliminated through proper data interoperability design. These novel data integration streams, however, must operate in compliance with strict FDA systems and data management requirements. Whereas the source and target systems may be in compliance and validated per the regulations, any intermediary that transfers and transforms data must be fully validated and compliant with all relevant regulations.

Our Adaptive eClinical Bus brings order to the chaos caused by data fragmentation by reliably integrating a client’s technology into an interoperable, efficient, and accurate clinical trials system

One of the major vendors that it collaborates with to help clients achieve desired data validity is Veeva, the leading trailblazer of industry-specific cloud-based software solutions. Through Veeva, Adaptive Clinical Systems addresses diverse operating challenges and regulatory requirements that often hinder CROs, pharma companies, and biotechs from maintaining their desired budgets and timelines. Adaptive Clinical Systems serves as a catalyst that allows Veeva’s clients to choose to build a best-of-breed solution comprising the features they like to significantly boost their ability to make the most of their Veeva implementation without losing legacy data assets. The Adaptive eClinical Bus can easily integrate new technologies often utilized in DCTs, such as biomarkers, wearables, and remote patient monitoring.

Creating a Culture Focused on Value and Curiosity

For every client engagement, Adaptive Clinical Systems brings in four values. First, its vast experience and strong Veeva partnership enable clients to rapidly interconnect with the third-party systems they need. Then, its platform’s vendor-agnostic nature can traffic any data and act as the backbone for eClinical workflows. The third value comes from its ability to optimize validation and compliance across disparate data sources. Finally, its ongoing data monitoring dashboards ensure that any biomarker that passes across its platform is assured to be Attributable, Legible, Contemporaneous, Original, and Accurate.

In a recently published study, Adaptive Clinical Systems provided data interoperability services for RWD and EHR to its partner, the Optum Digital Research Network (DRN). According to a feedback survey performed at the end of the study, 67 percent of site respondents indicated that extracting data directly from the EHR and loading it to the EDC saved them more than 50 percent of effort, and 83 percent indicated high or extremely high confidence in the accuracy and completeness of the data collected during the study. Concurrently, 100 percent of respondents indicated a moderate to extremely high certainty in using a similar data collection and management procedure for an interventional trial in the future.

With a culture encouraging curiosity, the leaders at Adaptive Clinical Systems are constantly watching the industry and seeking ways to help businesses use emerging clinical technologies in the framework of the FDA’s requirements. Moving forward, it aims to continue directing its efforts on modernizing information flow with intelligent middleware and sophisticated rules engines that drive innovation and true interoperability.