How can I contact someone about starting up a study?
There are a few ways to make contact with a CBSET representative: call us at (781) 541-5555 and ask to speak to a representative from the Business Development team, or send us an email.
What happens once the initial contact has been made?
However your contact to CBSET is made, we will talk through your existing scope of work or assist you in developing that scope of work by meeting with our experienced team of scientists. Based on the details provided from the scope of work, we will generate a detailed study quotation for your review. We can execute a mutual non-disclosure agreement at any time during this process.
What is standard study lead-time?
Once the study proposal has been executed, the lead time will vary based on study type, required resources, species and lab availability. In general, lead time for acute / non-survival studies are typically 2-3 weeks and lead times for survival non-GLP and GLP studies, range from about 3-5 weeks.
How often does your IACUC committee meet?
Our IACUC committee requires active current protocols for all experiments involving live animals. The committee meets routinely once a month, however, based on each sponsor’s needs, and it is able to conduct interim and expedited reviews.
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; however, any member of the CBSET team is available to help to address questions or issue as needed.
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, the extent of histopathology and regulatory compliance (non-GLP or GLP). Customized timelines are available and will be analyzed on a case-by-case basis.
Is it possible to generate a protocol to submit to FDA or to other Government Agencies (i.e., 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, including defending this protocol with the FDA by phone or in person. In advance of doing so, we will execute a quick proposal with nominal fee to cover this activity.
How can we formally schedule our study?
Once the Study Proposal has been executed and the study details are confirmed, the study can be confirmed in our schedule. In some cases, we can hold study dates for up to 48 hours while proposals are being signed/executed.
Is CBSET GLP Compliant? How can we schedule an audit of your facility?
CSBET is Good Laboratory Practice compliant facility (and has been so since opening its doors) 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. Feel free to email us at info@cbset.com to arrange a facility audit.
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.
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.
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 secure internet connection. Cases can also be recorded onto DVD for future use.
Are half-day sessions available?
Half-day lab sessions are available.
Where is the closest airport?
CBSET’s headquarters in Lexington are conveniently located 20 minutes from Boston Logan Airport, which makes our facility very accessible to international sponsors, as well as sponsors from around the US.