FAQs: Placing Studies at Toxikon
Who should I contact at Toxikon about initiating a study?
There are a number of ways. First, you can call our front desk and the operator at 1-800-458-4141, and they will be able to direct your call to the appropriate Toxikon representative. Second, you can contact Chaula Desai, Director of Sales and Client Services, at 781- 275-3330, ext. 144. Third, you can also visit our website to access the Business Development and Client Services Directory.
What happens once the initial contact has been made?
Your client service representative / business development manager will first initiate a mutual non-disclosure agreement, or we can use a Sponsor corporate NDA if that is more appropriate based on business needs. The non-disclosure agreement is executed, and then open discussions can take place relative to your development needs. As we assess the scope of your project, we also assemble the appropriate team of Toxikon experts to generate a study outline and quotation.
What is standard study lead-time?
Toxikon has the flexibility to provide Non-GLP proof of concept and efficacy support projects, pilot studies prior to launching full GLP studies here at Toxikon. We also conduct GMP testing. Study lead-time depends upon the scope of the study. For any pharma or ESRS projects, there is typically a 4 to 5 week lead-time once the quote has been signed to generate protocols, order supplies, and schedule the projects. Other departments have weekly schedules for routine projects that can be prescheduled for week or monthly start times. All study turnarpound times are planned in advance for all project and communicated to the sponsor.
How often does your IACUC committee meet?
Toxikon has several routine IACUC protocols pre-approved for rapid study initiation. Any non-routine studies are typically reviewed by designated IACUC review. Toxikon’s IACUC conducts full committee meetings at a minimum of five times per year or as required to meet sponsor protocol review demands.
How do I follow up on my study status?
Each Sponsor at Toxikon is assigned a Client Services Representative as well as a Business Development Representative. The customer service representative assigned to your project will keep you updated to study schedules and status. Any technical questions should be directed to the Study Director, or can be expedited through the Client Service representative.
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?
Toxikon’s facilities are fully registered with FDA and USDA, and accredited with the Association for the Assessment and Accreditation of Laboratory and Animal Care International (AAALAC) and International Organization for Standardization (ISO). Toxikon also has assurance with the National Institutes of Health so federally funded work can be performed at our facilities in compliance with NIH’s Public Health Service Policy on Human Care and Use of Laboratory Animals (PHS Policy). These agencies often request to review protocols before in-vivo studies begin. Toxikon will assist you in developing early-stage protocols, and will continue to assist you through the review cycles. Fees for these consultation services are credited back upon study initiation.
Is Toxikon GLP Compliant? How can we schedule an audit of your facility?
Toxikon is Good Laboratory Practice compliant facility and operates within all the required GLP guidelines. Toxikon has in place current Standard Operating Procedures which govern all areas of study conduct and animal care. Toxikon is also ISO 17025 accredited for full quality system compliance.
Can we bring our own doctor/surgeon/interventionalist? What type of documentation would they need?
Toxikon certainly welcomes outside physicians and researchers to participate in studies. Our facilities are equipped to handle multiple surgical stations to accommodate physician trainings and demonstrations. Our ESRS team offers full-set up and surgical monitoring to allow you to focus on the training. We will work with your partners to offer the most professional and collaborative environment possible. At Toxikon we can accommodate large groups and even provide remote visualization of procedures and surgeries within our facilities and around the world. Located outside Boston allows easy access to our facilities with local accommodations, making it the perfect place to hold your next training. 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 Toxikon provides.
Where is the closest airport?
Located 15 miles from Boston, in Bedford, MA, the closest airport is Boston’s Logan International Airport. For visitor information, log onto our Website’s Direction’s and Visitor Information page.