Biobanking Informatics

Selecting and implementing a biobanking informatics system is an important step. 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 inventory management systems and choose the one that is right for your institutional requirements. 

 "If you don't know what you have, you might as well not have it"

- Helena Ellis

Governance

Your biobank’s mission and goals are critical to identify before launching. Equally important are the key elements of sample and data access policies and procedures, business model and legacy plans. Let me help you develop a governance plan right for your institution. 

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. 

Budgets and Cost Recovery

Most biobanks need to recover at least some of their operation costs. I provide budget development and pricing structures for the services your biobank provides

Compliance: Development of Protocol and Informed Consent Forms

Too often consent forms are written in "legalese" to protect the institution.  Having a consent form that is age appropriate, easy to understand and meaningful is a researcher's obligation. Using published guidelines on readability and health literacy principles, I’ll write your consent form, or shorten your existing biobanking consent form, lower its reading grade level and improve the comprehension of your participants.

External Auditor- 

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. 

Biobank Relocation

If you are moving your biobanking resource or searching for a biobank provider, I can help you make strategic decisions to safeguard your valuable resource- both specimens and data.