General Information and Policies
GLP vs Non-GLP studies: Sponsors need to notify Clongen Laboratories staff at the time of requesting studies whether they are requesting a GLP or a Non-GLP study. Typically, studies intended to satisfy requirement by the FDA or the EPA need to be conducted under the Good Laboratory Practices (GLP) of the specific agency. GLP studies require that a protocol is approved by the sponsor (client) and the testing laboratory's Study Director. Clongen Laboratories, LLC operates in compliance with the FDA and EPA GLP conditions. Although we have standard formats for our final reports, we are willing to provide you with a specific report format if requested provided that you submit a sample that we can follow. Additional charges may be incurred depending on the extent of changes to be made.
Record Retention: All final GLP reports will be held by Clongen Laboratories, LLC for a minimum of five years in electronic and paper formats. Copies will be sent to client at no extra charge via USPS during the five year retention period. If the client request overnight delivery, additional shipping charges will apply.
Sample Retention: All samples sent for Non-GLP Molecular Diagnostics, Genetic Testing, Microbiology and Environmental Testing will be held for 60 days once the final report is sent out unless specified otherwise. Samples for Custom DNA Services will be held for a minimum of 6 months unless specified otherwise. All samples used in GLP studies will be held for 4 months following the receipt of final report by client.
STAT Studies: as some clients need their samples processed urgently, those requests will be honored when capabilities permit and a 50% STAT charge is assessed to cover schedule interruption, overtime, holiday and weekend work hours. Sponsor will be informed and must approve the STAT charges before testing is conducted.
- Prices: Our prices are on average 10-20% lower than our competitors. price quotes will be provided based on the description of the studies and any extra handling and processing. Price quotes are usually good for 60 days. A minimal charge will apply for duplicate reports and overnight delivery. We offer discounts to clients who maintain prepaid balances and for multiple submissions for the same test.
Prepayment Policy: We ask that a 50% prepayment is due for new customers before work can begin. The balance of the study cost is due once analysis is completed but before the final report is sent to the sponsor. Established customers are invoiced after their reports are received for a 30 day grace period (NET30). Studies over $3000 will require a 50% prepayment to cover costs of materials and other overhead before the study is initiated. We accept company checks drawn to US banks, wire transfers, American Express, Discover Card, Visa and Mastercard. Please contact us for help in making a payment.
Late Payments: Payments not received after 30 days of due date will be assessed a 5% late fee (No exceptions) and will result in an automatic cancellation of the NET30 account and switching to a prepayment account if more than one late incident occurs within a calender year.