Frequently Asked Questions

Frequently Asked Questions

Q. Do I need ethical approval to commence a project using human tissues?

A. No, Biopta deals with all ethical approvals and ensures that all appropriate compliance and legal requirements are in place before commencement of the study, leaving you to focus on the science.

Q. What is the turnaround time for studies involving human tissue?

A. Our human tissue network and ethical approval allows us to rapidly commence and complete studies. The typical duration of a study on for example, tissues donated by four to six patients (from study initiation to final report) is around 12 weeks.

Q. Is all intellectual property and raw data generated during the study owned by the client?

A. Yes, all raw data and discoveries during the project are owned entirely by the client upon full and final payment of study fees. Background IP owned by each party remains the property of that party.

Q.Are Biopta’s studies off-the-shelf designs or can I create a bespoke study?

A. Most of our studies are unique and tailored to the exact requirements of our clients. We will work with you to prepare a detailed protocol prior to the start of any experimental work and we are happy to discuss any ideas you might have for a project involving human tissue experiments or procurement. For the supply of tissues we will describe the inclusion/exclusion criteria for the patients, in a similar fashion to a clinical trial. We do also have a range of off-the-shelf designs that will answer many of the key questions about human safety and efficacy.

Q.Where does Biopta source its tissues from?

A.Biopta works only with reputable providers in Europe and North America.

Q.Is Biopta prepared to conduct a pilot study if the area of research is entirely novel?

A.Yes, we would be happy to conduct a small pilot study to determine the best approach and this is often conducted on a cost-sharing basis if Biopta is free to use the data generated during the pilot study.

Q.Are GLP studies possible?

A.Yes, Biopta was the first human tissue company to achieve GLP accreditation in 2005 and is the only functional human tissue company with GLP status. Regulatory bodies are increasingly looking for evidence of efficacy or safety in human tissues.

 

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