Initiating Your Testing Program
Thank you for choosing Toxikon for your preclinical testing needs. We are excited to begin your study program. Please review our sample submission process so that we can initiate your testing program quickly and efficiently.
Your account manager and client service representative are your key points of contact in this process. Please don’t hesitate to reach out to them with questions or requests for clarification. They will work with you to obtain the required documentation, submit test articles, and schedule your study.
The issued quote should include the quote number and initials on each page of the document.
Non-routine studies may require special approval and pricing from a Toxikon department head or authorized study director. Instances may include:
- Extractable / Leachable Programs
- Non-Compendial Analytical Chemistry testing (e.g. analysis for certain compound)
- Non-Lot Release Microbiology (e.g. sterilization validations)
- Surgical Research and Efficacy
- Ocular Programs
Toxikon will require a physical copy of the purchase order. Please ask your account manager for details.
Completed and Signed Test Requisition Form
To ensure proper and timely results of your testing, please fill out the appropriate Test Requisition Form:
|Test Request Forms|
|GLP / Non-GLP / GMP Test Request Form|
|Pharmaceutical Test Request Form|
|Microbiology Test Request Form|
|ETO Test Request Form|
|Accelerated Aging Test Request Form|
Complete one form for each test article being tested and reported separately. Please list GLP studies on the GLP Test Requisition Form and Non-GLP studies on the Non-GLP Requisition Form. Accurate and clear information will avoid delays in the testing process and report generation, as well as avoid possible amendment fees. The listed Test Article Name will be the name that appears on the report.
How To Fill Out Your TRF
Signed Protocols for GLP or Non-GLP Special Studies
Once Toxikon receives the signed quote, signed purchase order, and signed Test Requisition Form, a study director will be assigned to your testing program. The study director will write the protocol, which will be reviewed by Toxikon’s Document Control and Quality Assurance departments before being submitted to the sponsor for review and acceptance. The study director will work from the quote and discuss study design with the sponsor while writing the protocol. For surgical efficacy, pharmaceutical, and ocular studies, a study-specific Institutional Animal Care and Use Committee (IACUC) protocol is required.
Test Article Submission
Please send samples to:
Attn: Sample Log-In
15 Wiggins Avenue
Bedford, MA 01730
United States of America
After Toxikon receives the signed quote, approved purchase order, signed Test Requisition Form, signed Protocol (if applicable), and test article(s), your account manager will work with our Log-In Department to receive your test article(s) and initiate your study.
Please note that it is our policy to order animals and perform sample preparation after a study is logged in with the appropriate documentation. It takes approximately 2 weeks to order, receive, and acclimate animals before beginning the study.
After the study is logged-in, it can be scheduled in the laboratory. Tests are scheduled in the laboratory on a first-come, first-served basis. A pre-determined standard time limit is assigned to each test at log-in. This timeline allows for sample receipt, sample log-in, performing the test, data review, report preparation, approvals, and delivery.
If final results are needed within a critical timeframe, your Toxikon account manager can explain options prior to the start of your testing.
Expedited Study Requests (STAT)
Sponsor requests for a test and/or report to be completed in less time than standard turnaround time must be communicated to your account manager before initiating the study. Toxikon will make every effort to accommodate sponsor requests; however, scheduling will be dependent on current laboratory capacity. The sponsor must provide a purchase order for STAT processing fees.
Once the test is performed in the lab, the following steps occur:
- raw data review
- report preparation
- quality assurance review
- sponsor review (if draft report)
- final report preparation
- approval signatures
- transmission of results
Special studies may involve clinical chemistry, hematology, necropsy, histology, pathology, or contributing scientist reports, which all affect turnaround time. Certified copies of data, draft reports, amended reports, and second original reports will incur additional charges.