Lisa Mulcahy has an extensive career in the biopharmaceutical industry in the areas of Clinical Operations, Quality Management, and TMF Management. She became an independent consultant 16 years ago, tying previous work experiences together to assist clients to develop, revise, and operationalize high-quality and compliant TMF management processes to achieve complete and inspection-ready of TMFs. Her consultancy allows her the pleasure to work with clients, very small biotechs to large pharmaceutical companies, in many different ways, such as selection, implementation, and expanded use of eTMF systems, training and/or leading TMF management resources, performing quality and completeness reviews of study-specific TMFs, and performing a company’s TMF management assessments for clients so they can establish and/or improve processes to become more compliance and inspection ready. Each of her projects with the focused intent to achieve compliant, complete, and inspection-ready TMFs. Lisa is a co-founder and a current Steering Committee member of the CDISC TMF Reference Model volunteer team of industry representatives that created and maintain the model.