Outsourcing Biorepository Services: Is it Safer and Cheaper?

SELECTING THE RIGHT BIOREPOSITORY SERVICE PROVIDER FOR YOUR CLINICAL TRIALS

Clinigen Clinical Supplies Management’s high-quality biorepository services have provided comprehensive laboratory storage solutions to our clients for over two decades. We offer services that support comprehensive specimen life cycle management, which can begin with providing sample collection kits to sites. Other services include data management, processing, storage, retrieval, and destruction.

High-quality biorepository service practices are required to guarantee the integrity and quality of the samples while simultaneously providing a cost-efficient solution that supports your clinical trials’ needs.

The data that lies within biological samples hold the keys to the success of a clinical trial. An important aspect is the collection of samples, sample analysis, and preservation for retesting at a future date. Biological samples often degrade between the time they are collected and when they are tested.

It is therefore crucial to have a storage process in place that preserves sample integrity over time. The correct handling of the samples has a big impact on both the course and the results of clinical trials. External biospecimen repositories can act as an extension to your trial's operational and storage needs, ensuring that your project runs as smoothly as possible.

TOP BENEFITS OF OUTSOURCING BIOREPOSITORY SERVICES

• Cost savings
• Time and space savings
• Sample safety and integrity

BIOREPOSITORY SERVICES TAILORED TO YOUR NEEDS

We know that sample storage is a critical component of all clinical trials. That’s why a highly experienced biorepository will ensure that all biological samples are managed with professional procedures in place. When selecting a biorepository service provider, it is important to establish that they are capable of the following services and procedures, as listed below.

MONITORING AND ALERT SERVICES

Timely communication and 24/7 monitoring are of the essence when dealing with biological samples. You need to be alerted immediately if there is a problem with a sample or the logistics of the sample.

A BACKUP PLAN

Your samples need to be safe at all times, so having a full contingency plan is crucial. Sample and data loss can be avoided by implementing an efficient backup storage system powered by emergency backup generators.

21 CFR PART 11 AND EU GMP ANNEX 11 COMPLIANCE

21 CFR Part 11 is part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES), while EU GMP Annex 11 is about all forms of computerized systems used as part of European Good Manufacturing Practice (GMP) regulated activities.

EXPERIENCE

Extensive knowledge of identifying, collecting, storing, and distributing biospecimens over time for different clinical trials worldwide is key. With over 25 years of experience in biological sample management, 3M samples stored in 190 freezers in the US and the EU, Clinigen Clinical Supplies Management is an expert in transporting, storing, and handling biological samples.

BIOREPOSITORY STORAGE OPTIONS

Clinigen has the capacity for 450 freezers (EU) and 300 (US), including liquid nitrogen storage as well as bar-coded scanning and our unique over tubing process.

CLINIGEN CLINICAL SUPPLIES MANAGEMENT’S BIOLOGICAL SAMPLE STORAGE AND HANDLING CAPABILITIES

At a variety of temperatures including cold chain storage requirements:

• Ambient (15-25°C)
• +2-8℃
• -20°C
• -40°C
• -80°C
• -190°C Cryogenic (liquid nitrogen – vapour phase)
• Of blood, plasma, urine, faeces, tissues, serum, biopsies, cell cultures, paraffin blocks, DNA and other substances
• In all types of tubes, individually, by cryo-box or in bulk

THE ADVANTAGE OF OUTSOURCING BIOREPOSITORY SERVICES TO CLINIGEN CLINICAL SUPPLIES MANAGEMENT

There are many advantages of outsourcing your biorepository services to a specialist with years of experience backed by experts in the field. By outsourcing to the right team with a streamlined and secure process, you can save time and money managing your biological samples. When you choose to outsource to a biorepository that focuses primarily on providing these services, economies of scale are reached for both you and your clinical trial. This is because our production services are incredibly efficient, and cost-effective.

We offer comprehensive solutions to your clinical trial from an existing global network of depots.

Clinigen Clinical Supplies Management’s biorepository services include storage infrastructure, flow and location management, and data demographics. Our specialty is tailoring the solution to the specific needs and challenges of the client.

We offer services ranging from short- and long-term storage of the biological samples collected during a clinical trial to the management of a client's biorepository. Instead of working with multiple vendors, you have one point of contact, one solution, and one contract.