Ephicacy Consulting Group has appointed Dr. Shekhar Thumake as Head of AI, creating a new leadership position as the biometrics contract research organisation expands the use of artificial intelligence across clinical data operations.
In the role, Thumake will lead Ephicacy’s enterprise AI strategy and oversee the development of agentic AI capabilities aimed at connecting and streamlining clinical data workflows. He will also work with clients and delivery teams to identify applications for AI across regulated clinical research operations.
The appointment forms part of Ephicacy’s strategy to embed AI across the clinical data lifecycle while maintaining requirements around data quality, transparency, governance and regulatory compliance.
Thumake brings nearly two decades of experience spanning medicine, artificial intelligence, clinical development and data science. His previous work has included building AI innovation functions and developing multi-year strategies for applying technology across different stages of clinical trials.
His experience includes the use of the Clinical Data Interchange Standards Consortium’s Unified Study Definitions Model, or USDM, for protocol digitisation and interoperability. He has also worked on applying AI to unstructured clinical information for patient eligibility assessment and using natural language technologies to protect sensitive patient information.
Other areas of his work include predictive capabilities for clinical trial site selection and the use of generative AI in clinical study reporting. Previous material published by Axtria, where Thumake served as Director of Clinical Solutions, identified generative AI as a tool for integrating data sources, reducing manual effort and supporting clinical study report authoring.
Thumake’s appointment comes as AI is increasingly being applied to data-intensive functions within pharmaceutical research and development. Clinical trials generate information across protocols, patient records, study sites, statistical systems and regulatory documentation, creating opportunities for AI-assisted automation alongside requirements for validation and human oversight.
Agentic AI could extend that automation by enabling systems to perform sequences of defined tasks across connected clinical workflows. Ephicacy said Thumake will focus on developing such capabilities while incorporating interoperability, governance, quality and regulatory considerations into solution design.
The company has not announced specific products, deployment timelines or performance targets associated with the appointment.
Ephicacy Chief Executive Officer Tara Gladwell said advances in managing and analysing clinical data ultimately support patients waiting for new therapies, adding that Thumake brings clinical and technical experience to the role.
Thumake said effective AI applications in biometrics would need to combine scientific context, trusted data, interoperable standards and human judgement. He added that the focus would be on developing AI-enabled workflows suited to regulated clinical research.
Headquartered in Iselin, New Jersey, Ephicacy provides outsourced statistical programming, biostatistics, data management and real-world evidence analytics services to pharmaceutical and biotechnology companies, with employees and operations across North America and India.
The creation of the Head of AI position signals a more formalised approach to AI within Ephicacy’s biometrics operations, with the company placing responsibility for enterprise AI strategy and agentic clinical workflows under dedicated leadership.