Consolidate Your GCP Trial Biomaterials for Streamlined Storage and Savings

Jun, 2024 | GCP Consolidation

Life science research thrives on exploration and new clinical drug development at scale. However, managing the biological materials that fuel those discoveries can quickly become a logistical labyrinth.  

Sponsors Frequently Hire CROs for Research 

Biopharma companies will “sponsor” drug development and Good Clinical Practices (GCP) studies across a multitude of Contract Research Organizations (CRO) to increase their chances of discovering the next blockbuster drug. This approach reduces the burden of drug development from just internal researchers or a select few CROs. Casting a wide net across CROs is a best practice to improve time to market for new products and hedge against the risk of projects shuttered during development. 

After working with dozens of CROs, sponsors will need to manage their GCP study data and biological samples across an increasing number of unrelated providers. CROs specialize in research, not storage. This can lead to scattered data and potential compliance challenges down the line for the sponsor. 

There are several advantages of consolidating your GCP trial biomaterials into a single, specialized long-term storage provider designed specifically to meet GCP requirements. Here are three key benefits to consider:

1. Significant Cost Savings

CRO facilities optimize their site layout and hire talent for what they do best: research and development. While the CRO can drastically accelerate clinical development, they are not meant for long term storage of biological and clinical regulated material that needs to be stored for years, and even decades, after a GCP study.  

Since regulated storage space is limited, sponsors will need to pay a premium to leave their material at a CRO. Storage may be included in a CRO’s fees for a year or two while the GCP study is being conducted, but the prices drastically increase after that period. 

After the initial CRO storage period is complete, sponsors can save significant operating costs by consolidating their long term regulated material storage to a GCP storage specialist. A GCP storage company is designed for flexible, long-term storage, and their pricing reflects that. Instead of paying exponential costs to store at a CRO, sponsors can work out a long-term and bulk pricing commitment with a GCP storage company to score cost savings and pay one vendor for storage instead of dozens of CROs. 

Compounded over decades, working with a GCP storage specialist can save sponsors, and even CROs, millions of dollars.

2. Improved Regulatory Compliance and Oversight

Maintaining GCP compliance is essential for the integrity and validity of your clinical trial data. Having biomaterials scattered across various storage solutions can make it difficult to track their location, ensure proper handling procedures, and demonstrate adherence to temperature and humidity requirements.  

Individual CROs may follow different regulations based on the material being handled and their geographical location. Regulated material oversight becomes increasingly complicated with each CRO adhering to its own standards for regulatory compliance, reporting frequency and format, and customer access and support. 

Consolidating your regulated material with a dedicated long-term storage provider specializing in GCP compliance ensures your samples are maintained according to centralized regulatory and validation standards. 

3. Simplified Sample Management with One Point of Contact

Dedicated biomaterial storage providers employ experts with deep knowledge of biopharma cold storage requirements, regulatory protocols specific to GCP, and best practices for maintaining sample integrity. Consolidating your storage with such a provider gives you a single point of contact for all your regulated material storage needs. This ensures you receive expert guidance and prompt support whenever you need it, further strengthening your adherence to GCP and confidence in the long-term validation of your products and studies. 

Using a specialized GCP storage provider like GXP-Storage reduces the management headache of juggling multiple CROs for long-term storage. GXP-Storage offers streamlined billing, a consistent internal point of contact, and even a customer portal for 24/7 monitoring and access of your material. 

Instead of sending out emails to hunt down information in scattered storage locations, consolidation facilitates one place for billing, rapid retrieval, validation, compliance information, and audit support. 

Summary 

While CROs offer significant benefits to accelerate clinical development, they do not specialize in long-term storage. By consolidating GCP trial materials, sponsors can enjoy significant cost savings, improved regulatory compliance and oversight, and experience easier management and access to their regulated material.  

A consolidated storage expert allows sponsors to focus on research for scientific breakthroughs, not managing storage logistics and compliance. 

 

Sources and Additional Resources 

GXP-Storage offers compliant GxP solutions tailored to meet your requirements.

With decades of combined experience, we specialize in offering scalable storage solutions in our purpose-built restricted access facilities along with our 21 CFR Part 11 compliant validated inventory management system: GXP-Guardian℠. To learn about how we can help you consolidate and manage your research and manufacturing material, contact us or download our information sheet below.

Talk to a GXP-Storage expert. We offer confidential consulations to assess your needs and design a tailored solution.

Realize the benefits of the GXP-Storage Standard

To learn about how we can help you manage your regulated research and manufacturing material, download our information sheet.

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