Quality Research Essentials: Don’t Be the Next Cautionary Tale

JulieAnn Blasingim, VP of Compliance and Development, Elligo Health Research®

JulieAnn Blasingim has over 18 years of regulatory, operational and compliance experience in the human research protection field and currently serves as Vice President of Compliance & Development at Elligo Health Research.

At Elligo, Blasingim is a highly valuable member of the leadership team. She specializes in overseeing corporate-wide quality and training management systems. Blasingim vetted, selected, implemented and led the development of the current eQMS system. She is responsible for setting company quality objectives and standards, designing policies, procedures and systems that establish compliance. This includes coordinating with Security and Privacy Officers to develop information and privacy management systems. Given Blasingim’s extensive work history, she is also responsible for overseeing the corporate regulatory Intelligence Team, all US Food and Drug Administration (FDA) Inspections, Customer Audits, Company Quality Audits and Qualification Assessments. Blasingim drives efficiency in company-controlled document management, CAPAs and training for all internal staff and external Investigators.

Before Elligo, JulieAnn Blasingim served as the VP, Corporate Quality Assurance, Process Improvement and Training for Advarra. She is uniquely experienced to have a broad understanding of the entire IRB business, having served in several roles responsible for providing leadership and oversight within the organization, ensuring compliance with policies and regulatory requirements and providing timely and quality review services to clients.

Before Advarra, Blasingim played a key role in the development and expansion of several service lines at Schulman IRB, including clinical pharmacology/Phase I, institutional review and support, Central Oncology Review (COR) IRB panel and eConsent. She has also served as IRB Chair and led and organized the application process for AAHRPP accreditation, FDA audits, ISO certifications, project management, change management, process improvement and other strategic initiatives. She has also served as a key member of investor meetings and integration teams for six IRB-related mergers and acquisitions.

She holds a bachelor’s degree in education and a master’s degree in business administration specializing in leadership and has maintained her Certified IRB Professional (CIP) certificate for 10 years. She provides training and educational sessions within the company, to researchers and for professional learning groups and conferences across the research community and has also authored two training modules offered by CITI.

Debra Fontana, Consultant, Polaris Compliance Consultants, Inc.

Debra Fontana is a licensed pharmacist and life sciences industry quality and compliance professional with over 33 years of experience in pharmaceutical/biotechnology/CRO/software organizations of all sizes. She has a unique combination of GCP and GMP experience, with biologic, drug, drug-device combination product and software as a medical device experience. She has quality/compliance and information technology experience and is a strong believer in using technology to increase compliance and efficiency. She is currently working as an independent consultant, specializing in GCP compliance and quality assurance, TMF management/auditing, sponsor oversight of vendors/CROs, SaaS vendor auditing and computer system validation.

Linda McCarty, Co-Founder, Chief Legal Officer and Privacy Officer, Javara

Linda McCarty is a clinical research executive with over 20 years of experience working with organizations across the healthcare and life sciences industries. As Chief Legal Officer and Privacy Officer, she leads the development of Javara’s legal and regulatory architecture that is underpinning Javara’s integrated research model, developing legal strategies to enable the integration of clinical trials into clinical care within complex healthcare systems. Linda is also responsible for the management of the quality and safety programs at Javara. Linda holds a deep legal expertise with federal and state laws that impacts the conduct of clinical research within healthcare settings. Prior to Javara, she served as the General Counsel for PMG Research, Inc., from 2013 to 2017, where she managed responsibilities including legal activities, regulatory affairs, corporate compliance, and strategy. Before joining PMG, she was also a partner in a North Carolina law firm where her primary areas of practice were healthcare/life sciences law and corporate law.

Linda earned her LLM (Taxation) from Boston University School of Law; JD from New England Law Boston; and BA from San Diego State University.