MAY 2022LIFE SCIENCES REVIEW 19Moreover, the platform is equipped with an entire sub-infrastructure for monitoring the clinical data quality. In case it detects noisy or unclear data, the platform traps it and escalates the issue to the source vendors supplying the data, also informing the client. After identifying the root of the anomalous data, ACS applies a patch and revalidates it to adhere to compliance rules. The FDA, HHS, and GCP-compliant platform also has capabilities to accelerate data management and eliminate data transcription errors for trials of all sizes. By leveraging its Adaptive DataVIEW extension, the platform offers CROs and sponsors access to neatly organized, clean clinical data from different sources that provide them a complete, holistic view of their study.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 InteroperabilityTo 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. Going forward, ACS will be expanding its digital health technologies connector framework in line with the increasing role of patient-operated medical devices used in clinical trials. The company will also remain focused on formalizing its data capture and learning process, which Adibi calls "innovation experience." To that end, ACS has built a back-office framework where its teams can share and validate their findings and learning experiences with the captured data. Furthermore, the company looks forward to maintaining and managing its portfolio of connectors proactively so that the connectors can be suitably modified in keeping with changes and updates to the healthcare systems. All the while, ACS will be laser-focused on its goal to enhance clinical trial operations with efficient data integration and interoperability capabilities. Our platform is purpose-built for interoperability with any system used by clinical study sponsors or CROs in a clinical trial
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