If you still have some questions about BioStorage Technologies that haven’t been answered yet, check here. We gathered this repository of questions hoping to help. Of course, please contact us if the information you need isn’t answered here.
What do you do? (Are you just a big warehouse?)
We store, manage, track and distribute samples. We offer storage temperatures ranging from ambient to vapor phase liquid nitrogen. Sample types include clinical trial samples, preclinical samples, clinical trial drugs, cell lines, and many others. For a complete listing of the samples we accept, click here.
What is a Sample/Specimen Management Strategy (SMS)?
Sample management strategies vary among organizations. Overall, the goal of an SMS is for the organization to leverage assets (samples) for future research, eliminate costly development time, ensure informed consents are properly associated with the appropriate samples, and build an organization-wide online sample library to pull samples with multiple data points. Additionally, an SMS assists organizations with proactively managing samples with clear deadlines for discarding samples which follow organization and regulatory guidelines.
BioStorage Technologies can assist with creating an SMS and identifying current sample processes, locations and types of samples. We’ll then discuss your goals for research and development. Ultimately, we’ll work together to determine a solution that:
What can you store/transport/handle?
We store all of the following listed below. We can transport anything allowable under the International Civil Aviation Organization (ICAO), the International Air Transport Association (IATA), and country-specific regulations. Other materials may be stored as required.
Examples of Sample Types Stored:
Please contact us regarding any sample not listed
Do you store samples other than human samples?
Yes. See the complete listing above.
Do you store bulk drug substances?
We store clinical trial drugs and active pharmaceutical ingredients (API). Within the U.S., we do not handle controlled substances from the Drug Enforcement Agency (DEA). In Germany, we store everything with the exception of morphine-type drugs or radioactive material.
Do you store radioactive samples?
Yes.
Do you store animal and plant samples?
Yes. They may require Animal Health Monitoring and Surveillance (APHIS) permits or Convention of International Trade in Endangered Species (CITES) of Wild Fauna and Flora permits. We can assist you in obtaining the correct permits.
What temperatures can you store samples/specimens in?
We provide temperatures from ambient through refrigerated, -20ºC, -70ºC, -80ºC and vapor phase liquid nitrogen at –170ºC.
How do you monitor temperature?
We utilize an electronic system called ELPRO®. It is FDA Title 21 CFR Part 11 compliant and reads temperature four times per second. Then, it permanently registers the temperature into a non-editable fully-compliant audit trail every 10 minutes that is downloaded to our server monthly.
Do you put all of my samples in their own freezer?
This is dependent upon client request. For quick retrieval, we try to store samples from a project together—we can split the samples among several freezers for business continuity purposes upon client request.
What type of inventory management system does BioStorage Technologies have?
BioStorage Technologies has developed its own proprietary system called ISISS®—Intelligent Specimen Inventory Storage System. It is the only global, web-based, real-time, regulatory-compliant inventory system available today.
Where is BioStorage Technologies located?
We have custom-built facilities in Indianapolis, Indiana, USA and Griesheim, Germany. BioStorage Technologies’ facilities are strategically located near major international shipping providers, allowing the most expedient shipping and retrieval.
What couriers do you use in various countries?
BioStorage Technologies is a Lead Logistics Provider—our clients hire us to manage the movement, compliance, and regulations of their products from point A to point B while maintaining temperature and product integrity. We always consider the best solution for the job, utilizing special courier messengers, freight forwarders and airlines. We handle all of the logistical details so that our clients need not be bothered.
How are your carriers and couriers evaluated? What performance standards are used to select the best ones?
Our logistics team has over 60 years of experience with many different vendors. From that experience, they know which couriers perform well in our type of shipping situations, and which are better suited for certain types of services.
How do I ship samples to BioStorage Technologies?
Our dedicated logistics team can assist with the shipment of your samples by providing full support services to your samples’ location. We can provide cartons, dry ice, pre-conditioned refrigerated cartons, dry shippers, and other supplies necessary—even staff—so that the samples can be sent to us. We can also offer the same services to have them sent to another location (for testing, for example) utilizing the preferred shipping method.
To request assistance, please call 1 317 390 1866, or email: logistics@biostorage.com and provide the contact details and authorization for the sample transfer. We will take it from there. Our logistics team will handle completion of all import permits or other necessary documentation, track the shipment, re-ice samples in transit (if necessary), and notify you when the samples arrive.
Intelligent Specimen Inventory Storage System (ISISS®)
What is ISISS?
The Intelligent Specimen Inventory Storage System, known as ISISS®, is a proprietary software developed by BioStorage Technologies that facilitates biomaterial storage, tracking and reporting. ISISS provides full records for every sample while in storage or in transit.
It allows our clients to have control of their samples through real-time, 24/7 visibility.
You can also use ISISS to request shipments, notify us of incoming shipments, request destruction of your samples, and to run real-time reports regarding your sample inventory. When you request your samples through ISISS, they will be retrieved and shipped out within 24 hours.
Is there an extra fee for ISISS?
No, it is integral to our service offerings.
How many people provide technical support for ISISS?
We have a full-time staff devoted exclusively to IT technical support. In the event we need to be scalable for a custom project, we also have an external partnership in place with pre-trained, knowledgeable staff.
Can you link our IVRS system to your ISISS system? What about any other system?
Yes. Our technology team will work with yours to achieve this link. We are able to execute intricate interfacing into client systems, or provide superficial web interfacing, based on client requirements.
Confidentiality Agreements/Pricing
Do you have a standard CDA?
Yes, we do. You may request one by contacting us.
Can we rent entire freezer units, rather than pay a per sample fee?
Our approach is to work with our clients to understand your business and your current and future needs for sample management and biorepository services. With this information, we work with you to put together a plan of action.
Has BioStorage Technologies been audited by the U.S. Food and Drug Administration (FDA)?
Yes, the U.S. facility has been inspected by the FDA for Good Tissue Practices (GTP) and is GTP compliant for storage and distribution of donor material for transplantation. The most recent FDA audit for GTP was in January 2009 and resulted in no 483s. We welcome audits from clients and potential clients to review our quality programs and witness our focus on the most up-to-date regulations across the industry.
How long do you maintain your records?
Sample records in the Intelligent Specimen Inventory Storage System (ISISS®) are maintained indefinitely. Transport documents are stored/maintained according to government regulations. Transportation documents are maintained for five years per the International Air Transport Association (IATA). These documents are also electronically scanned and kept indefinitely. Data records associated with samples are kept indefinitely, via ISISS.
Do samples need to have a bar code?
We can register samples of all types whether they have a bar code or not. All samples are individually registered into the ISISS inventory system—those which are bar-coded will be electronically entered while those without a bar code are registered manually.
Do you make and distribute Clinical Trial Lab Kits?
Yes. We partner with Therapak Corporation to design and produce kits, while we administer the distribution process. Therapak Corporation is a leading supplier of diagnostic test kits used by hospitals, physicians, laboratories and pharmaceutical companies worldwide.
BioStorage Technologies Appoints New Global Director of Supply Chain
Job Postings!
BioStorage Technologies is now hiring!
Global Sample Management: Benchmarking Symposium
15 September 2010
BioStorage European Headquarters
Im Leuschnerpark 1B
64347 Griesheim, Germany
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