FREQUENTLY ASKED QUESTIONS ABOUT CBSET

  1. How can I contact someone about starting up a study?
    There are a few ways to make contact with a CBSET representative: you may call the front desk at (781) 541-5555 and ask to speak to a representative from the Business Development team, call the Director of Sales and Marketing at (781) 541-5591, contact the study director who last led your study, or complete the info request form.

  2. What happens once the initial contact has been made?
    However your contact to CBSET is made, we will first make sure to execute a mutual non-disclosure agreement. Once that has been put in place, we will qualify your existing scope of work or assist you in developing that scope of work by meeting with our experience team of scientists. Based on the details provided from the scope of work, we will generate a detailed study quotation and send that to you.

  3. What is standard study lead-time?
    Once the study proposal has been executed, the lead time will vary dependent on study type, required number of resources, specie type, and lab availability. But in general, it can be assumed that for an non-survival study type, lead time is typically two weeks for animal preparation and protocol generation, for survival non-GLP and GLP study about three to four weeks.

  4. How often does your IACUC committee meet?
    Our IACUC meets routinely once a month, however, based on each sponsor’s needs, it is able to conduct interim and expedited reviews.

  5. How do I follow up on my study status?
    Each study that is conducted at CBSET is assigned a Study Director who serves as the central point of contact throughout the duration of the project. As CBSET complies to GLP regulations, the Study Director acts as the single point of control for all study related matters.

  6. What are the standard reporting and deliverable turnaround times?
    Timelines are determined based on study complexity and volume of data generated from the conduct of that study. 8-12 weeks following completion of all data generation (in-life and any study endpoints such as histopathology, etc) is considered to be the standard turnaround for a Draft Report. Customized timelines are available and will be analyzed on a case-by-case basis.

  7. Is it possible to generate a protocol to submit to FDA or to other Government Agencies (ie for Grant Submittal, etc) in advance of setting a study initiation date?
    It has become increasingly common for these agencies to request a protocol for review in advance of scheduling any in-life activities. We can certainly assist in developing a protocol in these early stages and will work with you through the review cycles. In advance of doing so, we will execute a study proposal and set an upfront compensation amount to cover this activity.

  8. How can we formally schedule our study?
    Once the Study Proposal has been executed and the study details are confirmed, we can go ahead and set a study schedule.

  9. Is CBSET GLP Compliant? How can we schedule an audit of your facility?
    CSBET is Good Laboratory Practice compliant facility and operates within all the required GLP guidelines. CBSET has in place current Standard Operating Procedures which govern all areas of study conduct and animal care.

  10. Can ex-vivo or bench top work be performed at CBSET?
    CBSET can host ex-vivo or bench-top work in any of its laboratories.

  11. Can we bring our own doctor/surgeon/interventionalist? What type of documentation would they need?
    CBSET certainly invites outside physicians to participate in studies. In order to do so, we require a CV that demonstrates that individual’s qualifications to participate in a particular study, as well as a signed Humane Care and Animal Welfare Statement, which CBSET provides.

  12. What video or media capabilities do you have?
    CBSET has audio-visual capabilities in both of its catheter labs that allow for live viewing either in the adjacent conference room or over a web stream. Cases can also be recorded onto DVD and taken home at the end of the lab.

  13. Are half-day sessions available?
    Half-day lab sessions are available.

  14. Where is the closest airport?
    CBSET is conveniently located 20 minutes fromf Boston Logan Airport, which makes our facility very accessible to international sponsors, as well as sponsors from around the US.

  15. CBSET is a non-profit company. How do I make a charitable donation?
    You can click here to contact us about making a donation.