Kamila Novak holds MSc in molecular genetics. She has been involved in clinical research since 1995, having worked in various positions in pharma and CROs. Since 2010, she has been working as an independent consultant and incorporated in 2019. Her business activities include auditing, SME consulting for QMS establishment and process improvements, medical writing, and training. Kamila is a certified Lead Auditor for ISO 9001, ISO 31000, ISO 13485, and ISO 15189, a trained auditor for ISO 14155, cGMP-QMS, and GXP. She is a member of the EMWA, the DIA, the CPD UK, the SQA, the Association for GXP Excellence, the WMDO, and other professional societies. In the SQA, she is the Chair of the Beyond Compliance Specialty Section.

Douglas Drake, MS, MBA, is originally a life science researcher with a passion for digital enablement of better patient care. With over 30 years of experience working in various aspects of diagnostics, therapeutic research and drug discovery, Douglas has broad experience in transformative technologies, data sciences, global business development and applying these to improving patient engagement and the patient journey.

Nikhil Kumar is the Founder of Applied Technology Solutions, Inc. (ApTSi). Nikhil is a thought leader in Semantic Interoperability with decades of experience in interoperability and the healthcare field. He is also an industry expert in Digital Transformation, Security, Service Oriented Architecture, and Cloud Computing. At ApTSi, Nikhil is involved in the development of a platform for Precision Medicine, covering Patient Centricity, the OMICS, and Translation Medicine. He is actively involved in the development, definition, and implementation of interoperability in a world of big data, distributed systems, eventual consistency, and AI.

Nishi Sharma is the Functional Lead of Clinical Technology in the Clinical Research and Development department of Cipla Ltd. With more than 13 years of industry experience, Nishi’s role has evolved by leading the team throughout the data management domain. She was instrumental in the implementation of EDC, CTMS, project management tools, and various medical device-based technology solutions. Her focus is currently on leveraging analytics in data management processes for efficient execution.

Rob has 15 years of industry experience working on clinical trials, both from the CRO and Sponsor perspective. Originally, Rob started as a CRA at a small CRO for three years, then moved to United Therapeutics (UT), a Biotech company, where he has been for the past 12 years. At United Therapeutics, Rob has held various roles as a CRA, Clinical Trial Manager, and Clinical Oversight Lead. For the past three years, Rob has been managing the CTMS. He was also selected as part of the team that uses Remarque QRMS at United Therapeutics.