Two decades of experience in the field of Biobanking
Headquartered in Durham, NC, Biobanking Without Borders, LLC, advises US clients on how to raise quality and improve efficiency in their biobanking practices, as well as how to establish a compliant, ethical new biobanking program. Special areas of expertise include biobanking data management, eConsent, governance, sample and data access policies, and Ethical, Legal and Social Issues(ELSI), including IRB biobanking protocols and easy to understand consent forms.
Email me TO learn how I can bring value to your biobanking practices.
helena.ellis@BiobankingWithoutBorders.com
Areas of Excellence
Laboratory Information Management System (LIMS)
"If you don't know what you have, you might as well not even have it"
- Helena Ellis
Without proper annotation, in a compliant and secure system, you cannot track chain of custody and key pre-analytical variables that are critical for downstream analysis. I can help you assess LIMS and choose the one that is right fit for your organization.
ETHICAL LEGAL AND SOCIAL ISSUES (elsi)
Expert advice in the informed consent process, ethical obligations and best practices and the value of community engagement. Without the participant, biobanks would close their doors. Planning for a new biobank should include the voice of the participant, and they should be included in discussions regarding recruitment, consent and sample and data access and distribution.
INFORMED CONSENT
Too often consent forms are written in "legalese" to protect the institution. Using published guidelines on readability and health literacy principles, I can shorten your biobanking consent form, lower its reading grade level and improve the understanding of your participants. I also have experience with selection and implementation of eConsent platforms, which are a great way to engage participants and help with regulatory compliance in multi site biobanking studies.
biobanking governance
Your mission and goals are critical to identify before launching your biobank. Also critical are the key elements of a governance plan, including sample and data access, a business model and legacy plans. Let me help you develop a governance plan that’s right for your project.
budgets and cost recovery
Most biobanks need to recover at least some of their operating costs. I provide budget development and pricing structures for your biobank’s services.
external auditing-
Is your biobank working striving for accreditation by the College of American Pathologists? Let me serve as an external auditor to help you develop strategies in preparation for your inspection, review your Quality Management plan, SOPs, and identify areas for improvement.
“Biospecimens and pathologists are at the center of the Personalized Medicine universe.”