For pharmaceutical companies without the capabilities to store their own samples, finding a third-party repository is crucial for clinical trials and other important operations.
MRIGlobal offers full-service repository management support for pharmaceuticals. We take pride in catering our operations to fit client needs rather than find a ‘one size fits all’ approach.
Headquartered in Kansas City, MRIGlobal is a not-for-profit contract research organization specializing in human health, pharmaceutical sciences, in-vitro diagnostics, defense, energy, agriculture, and global health. Our solution-driven teams are dedicated to finding answers that will make the country and world safer for all.
Read on to learn more about our pharmaceutical repository services and how we can help you manage your samples.
What is pharmaceutical repository management?
MRIGlobal’s pharmaceutical repository management is a full-service warehouse operation that receives, catalogs, stores, aliquots, ships, and even disposes samples for clients across the country. Operated by our experienced staff with board capabilities, the samples we receive come in many different forms. This may include:
- Finished drug products
- Drug substances
- Regulatory starting materials
- Kit components
- Reference standards
- Reference markers
- And more
In most cases, we have the ability to receive and house samples for any time period required. We can also distribute samples upon request, whether it be to our analytical staff or our clients and users.
A major benefit of MRIGlobal’s pharmaceutical repository services is our pristine cleanliness and organization.The contents are properly stored and accurately labeled. Our inventory management system ensures quick retrieval after a request.
In general, our specialized repository services include:
- A large worldwide laboratory network with a variety of clinical samples
- Stability chambers in a variety of storage conditions (subambient, (- 80°C, – 20°C, refrigerated, different temperature and humidity combinations, controlled room temperature)
- Clinical sample collection, receipt, storage, distribution, and electronic chain-of-custody tracking systems
- Support for large repository collections and sample inventories
- Ability to store Scheduled Substances (3-5) under GMP conditions
- Integrated research information network to improve sample management and facilitate transmission of data between partner organizations
- Assistance with importation of materials manufactured outside of the US
- Complementary laboratory capabilities (outside of the repository) and support for rapid and routine sample authentication and characterization testing
Bonus: Clinical trial support and management
Did you know we can help clients throughout the clinical trial process? We do. We are the necessary bridge that connects researchers to the doctor to the patient. MRIGlobal acts as the party that keeps everything secure and safe. That way, we can help you distribute samples in order to get medications and drugs to patients more efficiently.
Our clinical trial offerings come with:
- Supply management
- Receipt and distribution of materials
- Clinical label design and production
- Custom kitting
- Blinded samples preparation
How to get started with our repository services at MRIGlobal
We are flexible in meeting the repository needs of our clients. We have taken everything from a verbal description of what a client wants all the way to a formal request for proposal. From there we write a proposal to establish timelines, milestones required, deliverables, and budget. After both parties review and approve the contract and once the scope is developed and presented, we can begin receiving samples in about a week.
If you’re curious about getting started, you can always come in for a tour. That way you can view our facility and learn more about storage options. Additionally, we invite you to take a virtual tour of the facility by clicking here.
Frequently asked questions about pharmaceutical repository services
One of MRIGlobal’s primary goals in providing a pharmaceutical repository is to ensure our clients know the ins and outs of our services before they make a long-term commitment. We recently sat with John Cookinham, our Facility and Repository Operations Manager, to answer some of the most frequently asked questions he receives from clients and potential clients about our repository services and stability offerings.
For a quick overview, you can watch our brief video where John Cookinham explains how pharmaceutical repositories at MRIGlobal work.
What makes MRIGlobal’s repository services stand above the rest?
Simply speaking, it is our size that helps our repository services stand out. We are a smaller operation, so we can tailor our operation to your needs. That means we can treat a small company like a big company. On the other hand, if you go to a larger repository facility, they may say, “This is how we do it,” whereas our clients can say “This is how we’d like it done.” As long as your wants follow regulatory requirements, we are willing to explore and make sure you are satisfied.
In addition, a lot of our clients are small virtual companies or small office companies, and they don’t have the ability to store their own materials. We then become the company that can be their storage facility and analytical backup. To provide those extra services (such as sample analysis) we do a lot of joint programs with the analytical staff at our Volker location.
Are repository contracts month to month or signed for a certain term?
Our contracts are not month-to-month. We typically have clients sign a 12-month contract or another interval of 12. However, we will accommodate shorter contracts if someone has a quick turnaround project and will not need repository services for longer than a year.
Does MRIGlobal’s repository services offer sample data or any kind of advice?
MRIGlobal’s repository services alone do not offer sample data, but we can distribute samples to our analysis staff for more information. We do offer advice based on our experience, if needed. For example we could recommend using a two- or three-panel label instead of a one-panel label in order to fit the information your sample requires. We can also help with kit design by finding the best ways to combine vials, syringes, and other dosing tools with their samples. That way, everything is good to go for distribution.
How do you know which stability variables I need, based on my samples?
Stability variables and protocols are established by the analytical staff working in conjunction with you and your staff. The analytical staff then provides that information to us, and we store the sample based on their recommendations. A lot of protocols stem from FDA guidance and expectations. So we do not determine the variables on our own; we simply use the knowledge we are given to create the best possible drug storage environment.
Can MRIGlobal distribute my samples?
Yes! Our staff at MRIGlobal can distribute your samples. We have a variety of shipping options available, depending on your specific needs. Some samples can simply go out in a standard corrugated box. Others may need specialized shipping containers for dangerous goods or controlled temperatures, both of which we offer.
Our entire staff is trained in International Air Transport Association (IATA) regulations for dangerous goods shipments. We also have connections with several shipping companies for temperature-controlled shipments, which provide temperature loggers so you know your samples stayed in-range during the process.
Do you provide repository services for anything outside of pharmaceuticals?
As of now, our pharmaceutical repository services are limited to pharmaceutical samples, reference standards, and starting materials. If you have any questions on whether your samples will be a good fit for our facility, you can always schedule a time to visit our repository.
Benefits of working with MRIGlobal
There really isn’t a lot we can’t do or won’t attempt to do, which is why many of our customers come to us in search of innovative solutions. Everyone involved all the way up to our CEO is excited about solving the problems that have no clear answers.
Regardless of the industry or department, customers come to us asking, “Is this possible?” Oftentimes through our experience and research, we find that the answer is typically yes and we discover ways to go about it. From there we create a schedule, budget, and clear timeline to assure our customers that we will do what we say we can do.
Our drive, along with disciplined program management, is how we deliver the highest quality services and continue building a credible reputation around the world.
Learn more about the pharmaceutical repository services at MRIGlobal
For more than 75 years, MRIGlobal has advanced scientific research across a variety of industries. We focus on supporting better health outcomes on a global scale. For us, it’s not simply about science; it’s about the people who make it all happen.
Our solution-driven approach drives solutions for even the most complex situations. Through our dedication, we can solve any technical problem.
If you’re part of an agency, business, or academic institution seeking help with a project, use our Project Quote Tool to get started today.