Over two decades of experience in the field of Biobanking
Headquartered in Durham, NC, Biobanking Without Borders, LLC, advises US clients on navigating change at their biobank. Change may include improving quality by gaining Biorepository Accrediation by the College of American Pathologists. Perhaps your clinical biobank needs a protocol and easy to understand consent form. 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.
Contact me to learn more about how I can help your biobank succeed.
helena.ellis@BiobankingWithoutBorders.com
Areas of Excellence and Experience
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 choose the LIMS that is right fit for your organization. I can assist with data cleaning, data standardization and data import to your new system.
Ethical, Legal and Social Issues
I provide expert advice in the informed consent process, ethical obligations and best practices and the value of community engagement. Without participants, 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 Forms
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 tailored to your your biobank’s services.
Preparing for Accrediation
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, identify areas for improvement and help ensure your success. My six years serving on the Accrediation Committee has given me insight and experience into the accrediation process.
“Biospecimens and pathologists are at the center of the Personalized Medicine universe.”