| Establishing a Rare Disease Biobank Nonprofit Patient Advocacy Client A nonprofit organization founded by patient advocates approached TKG to lead the design and implementation of a rare disease biobank. The new bank presented special logistical challenges due to the need to access cases wherever they arose in the United States. TKG worked on a one year consulting project, building capacity within the organization both for technical program aspects and for grant readiness. Services provided included vendor evaluation and selection, contract negotiation, development of work flows and standard operating procedures, preparation of the IRB protocols and consent forms, information systems assessment, design of patient brochures, and preparation of grants and budgets. |
IRB Protocol and Consent Consulting, Commercial Biobank
A corporate client wanted to expand its services into prospective
biospecimen procurement at multiple centers. TKG assisted the
client in selecting an IRB with specific expertise in the biobanking
regulatory climate. TKG then provided guidance to the client
regarding their operational procedures, working with them to
assure implementation of best practices prior to developing a final
IRB protocol and consent form. TKG also worked with the PI and
senior staff to ensure organizational readiness and completion of
appropriate training.
A corporate client wanted to expand its services into prospective
biospecimen procurement at multiple centers. TKG assisted the
client in selecting an IRB with specific expertise in the biobanking
regulatory climate. TKG then provided guidance to the client
regarding their operational procedures, working with them to
assure implementation of best practices prior to developing a final
IRB protocol and consent form. TKG also worked with the PI and
senior staff to ensure organizational readiness and completion of
appropriate training.
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| Biobank Consulting
existing biorepositories of all sizes. We have a 20 year record of building successful, high quality biospecimen resources. Services include:
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| The Kellyn Group, LLC info@kellyngroup.com (410)745-4277 |