TEAM PARTNERS

Neala Lane has been involved with the conduct and oversight of clinical research in Academic Medical Center settings for more than 20 years.  After her start as a study coordinator for clinical drug development trials, she gained additional experience with IRB, VA, and FDA regulatory submissions before serving as a study monitor for investigator-held IND and IDE trials.  Ultimately, she transitioned into study auditing and has led the research compliance auditing program at her current institution for the last 7 years.  In this role, she has expanded the program’s audit scope to include reliance, multi-site, and minimal risk projects, and has developed a number of additional compliance initiatives to expand the overall research compliance mission. One such initiative was the centralization and coordination of all FDA BIMO inspections across the institution which has allowed her to personally observe and facilitate more than twenty-five FDA Clinical Investigator inspections.  Other accomplishments include the restructuring and expansion of the ClinicalTrials.gov compliance oversight program and the establishment of a CAPA verification program.  As part of the Human Research Protection Program’s senior leadership, she is also responsible for the quality assurance of IRB membership documentation and meeting minutes to ensure FDA inspection preparedness.  

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As part of her commitment to education and training, Ms. Lane serves on her institution’s clinical research education planning committee, co-chairs the sponsor-investigator training program, and is a regular presenter on human subjects research protections and compliance issues.  Neala also provides consulting services on an ad-hoc basis.  As a consultant, Neala specializes in directed study audits to evaluate for potential noncompliance, in preparations for potential FDA clinical investigator and IRB inspections, in quality assurance/quality improvement program development, and in auditor and research personnel training.