Making clinical data easily accessible, consistent, and usable for clinical study sponsors and CROs is Adaptive Clinical Systems (ACS). Spinning out from a major CRO, the life sciences technology company integrates clinical data from multiple sources for clinical trials in the pharmaceutical and medical devices sectors. The company’s dedicated team of technologists and software developers has created a platform that connects disparate data sources to solve the lack of interchangeability of clinical trial data among various eClinical systems, electronic medical records (EMR/EHRs), medical devices and digital health technologies. “Our platform is purposebuilt for interoperability with any system used by clinical study sponsors or CROs in a clinical trial,” says Sina Adibi, founder and CEO of Adaptive Clinical Systems.
The “Broker” of Clinical Data
The Adaptive eClinical Bus, ACS’s robust, innovative, cloud-based SaaS platform, acts as an aggregator of clinical data from diverse sources. It seamlessly integrates with the electronic data capture systems (EDC), clinical trial management systems(CTMS), electronic patient-reported outcome (ePRO) and interactive web response systems (IRT), medical imaging, analytics, data acquisition systems, and EHR/EMRs like Epic Systems and Cerner. The Bus features a data view dashboard that contains the whole gamut of information pertaining to clinical data from multiple studies across various levels – from patient to study to the clinical program. Aiding the platform is a range of clinical trial tools – dubbed “connectors” – allowing access to around 90 percent of all available data on eClinical tools, and about 75 percent of EMR records.
Moreover, the platform is equipped with an entire sub-infrastructure for monitoring the clinical data quality.
Adaptive Clinical Systems: Simplifying Data Integration for Clinical Trials
With the platform, ACS oversees the entire clinical trial on behalf of clients, from the initial setup to study launch. At the project initiation stage, ACS builds the data flow architecture for capturing the required clinical data, from which they derive the required configuration needed for the Bus based on the clinical trial protocol and data management plan. Following this, they set up and configure the requisite connectors to pull the clinical data from different sources. Post the setup, ACS lays down the data transformation rules that are used to filter the captured data in accordance with the criteria mentioned in the protocols.
Simultaneously, ACS also takes certain workflow aspects into consideration to filter the data by placing conditionals to determine when and where data is pooled or released. The filtered data is made available to the clients post strict adherence to compliance rules. Here too, ACS takes utmost care to prepare the recorded data documents, executes the data validation process, and also provides clients with the necessary attestations required to authenticate the documents. Finally, once the clinical study commences, ACS constantly monitors the clients’ systems to ensure the proper functioning of the data flows.
Accelerating Clinical Studies with Interoperability
To showcase ACS’s capabilities, Adibi mentions an instance of a client engaged in sourcing clinical data from a large network of hospitals and websites to conduct a clinical study to test a proposed treatment for Type 2 diabetes, as well as to check the feasibility of directly collecting data from EMRs. The client commissioned the company to collect data from all the EMRs in the network and harmonize it. Post normalizing the data and automating the process of data transcription on its platform, ACS uploaded it on an EDC system for the client to perform data management. Data from patient pre-screening for testing eligibility to gathering patient consent, along with data pertaining to clinical care visits and telehealth consultations, enabled the successful conclusion of the yet-to-be-published study with an unmatched degree of precision. “The participants had complete confidence in the accuracy and completeness of the data. It saved them a lot of time, which translates to hard dollars for the CRO and the sponsor,” remarks Adibi.
Our platform is purpose-built for interoperability with any system used by clinical study sponsors or CROs in a clinical trial