EDETEK Inc, a global provider of digital clinical platforms and AI driven solutions, has announced the launch of Ensemble, a new AI managed services offering created to help life sciences sponsors adopt and scale artificial intelligence across clinical development. The announcement aligns with EDETEK’s participation at the 44th J P Morgan Healthcare Conference and reflects the company’s continued focus on advancing innovation while maintaining regulatory rigor.
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Ensemble is designed to deliver enterprise ready AI that is validated, fully integrated into clinical workflows, and overseen by human experts. The service combines carefully selected AI models, agent based automation, and deep domain expertise spanning biometrics, data management, medical monitoring, and regulatory affairs. It is delivered as a managed environment that is inspection ready and supported by service level agreements. At scale, Ensemble supports outputs such as statistical analysis plans, SDTM and ADaM datasets, tables listings and figures, clinical study reports, protocol compliance alerts, and audit review support. The platform follows a risk based computer software assurance framework and includes controls aligned with regulatory requirements for electronic records.
Dr Shakthi Kumar, Chief Strategy and Business Officer at EDETEK, explained that sponsors are looking beyond experimental pilots and want solutions that deliver real operational value. He shared that Ensemble brings together the full AI stack including secure infrastructure, coordinated model management, and agent driven workflows, all supported by EDETEK’s biometrics and regulatory expertise. This approach allows organizations to deploy AI at scale without the burden of managing fragmented technologies or navigating complex compliance demands.
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Jian Chen, Chief Executive Officer of EDETEK, noted that Ensemble allows sponsors to access AI as a fully managed capability rather than a collection of disconnected tools. He emphasized that the service combines advanced technology with functional expertise to help organizations shorten timelines, strengthen compliance, and improve overall quality from individual studies through portfolio level execution.
What sets Ensemble apart is its end to end design for clinical development. The platform selects the most appropriate large language and multimodal models for each task and applies structured retrieval and evaluation methods to balance accuracy, safety, performance, and cost. Human review remains central, with experts across data management, statistics, medical monitoring, and regulatory functions validating outputs before they are used. Deployment options include secure cloud environments as well as private or on premises configurations that protect data residency and intellectual property while enabling modern AI capabilities.
EDETEK’s platforms and services are supported by recognized industry certifications, including ISO standards for information security, privacy management, cloud security, and AI governance. These certifications reinforce the company’s commitment to responsible AI use, data protection, and regulatory compliance.
As clinical development grows more complex, sponsors face challenges such as fragmented data, interoperability gaps, and increasing validation requirements. Ensemble is built to address these issues by unifying standards based data pipelines, integrating analytics and reporting, and embedding human oversight aligned with real world operating procedures. EDETEK is now engaging with sponsors and CROs to explore how Ensemble can help accelerate development programs while maintaining trust and quality.
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