How are Advancements in Technology Reshaping the Roles and Capabilities of CDMOs and CROs in the Drug Development Life Cycle?

Diane Lacroix, Vice President – Clinical Data Management, eClinical Solutions

Modern clinical trials face significant challenges, from trial design to operational intricacies and data management. Technology and scientific innovation have made it easier to collect increasing amounts of data, but this not only places critical burdens on patients and sites — it complicates the data operations of research. Biometrics teams must now possess technical skills, therapeutic-area-specific data expertise, and an adaptable mindset to navigate this data-heavy environment. Traditional full-service outsourcing models often downplay the priority of data in trials and lack the flexibility required for complex, data-driven studies.

Biopharma companies are more focused than ever on data as the critical asset of their studies and organization. As a result, sponsors are emphasizing several key priorities in their outsourced strategies: efficient management of data complexity, the ability to leverage technological advancements, and a move beyond operational execution to technology optimization (including adoption of AI and risk-informed approaches).

Outsourcing partners offering domain and function expertise around clinical data can address sponsors’ priorities to streamline data operations. This reshaping of a data-focused outsourcing strategy addresses widespread trial efficiency needs while helping life sciences organizations advance toward a comprehensive clinical data science framework, establish the foundation for AI-enabled productivity, and gain study and program-wide effectiveness.

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Diane Lacroix

Vice President, Clinical Data Management, eClinical Solutions

Diane Lacroix is a data management professional and leader with over 20 years in the pharmaceutical/CRO industry. As VP, Clinical Data Management at eClinical Solutions, Diane is responsible for leading the data management function including building effective process and implementation strategies to ensure that clients receive maximum value and quality from the elluminate driven data services that Diane’s team delivers. Diane’s career in data management has included numerous leadership roles both at service providers and on the sponsor side. She has worked on all aspects of global trials from study start-up through to database closure and submission leading and managing successful teams and projects to ensure high quality and on-time delivery of clinical data assets. Diane has deep expertise in the oncology and rare disease therapeutic areas and in data management technologies including EDC (Electronic Data Capture) systems and integration and analytics technology platform like elluminate.