In recent years, the landscape of pharmaceutical research and development has undergone a significant transformation, with biologics steadily overtaking small molecule drugs in prominence. This shift has brought forth a new era in clinical trials, where the complexity of biologics necessitates a more comprehensive approach to data analysis. Multiomics, the integration of various omics technologies like genomics, proteomics, and metabolomics, has become increasingly crucial in understanding the intricate mechanisms of these biologic therapeutics.
In this evolving paradigm, the need for sophisticated analytical platforms and robust biorepositories has become paramount. Sampled’s Global Integrated Analytical Biorepository (GIAB) emerges as a cornerstone for researchers, offering unparalleled capabilities in managing and analyzing complex biological samples. In this article we look at 5 reasons how the GIAB is poised to revolutionize clinical trials.
Table of Contents
1. Access to Expertise
At the heart of Sampled’s GIAB lies our team of technical experts. With extensive experience in biobanking, sample processing, kitting and multiomics analysis, our experts ensure the highest standards of sample management, storage, and analysis by following up to date SOPs and best practices.
One example of how our experts can help is when it comes to completing sequencing investigations, this type of research can be daunting if you are new to sequencing or have never performed whole exome sequencing before. Even if you have the right sequencing platform in-house, you may not have the right team of experts to sequence your samples, and just one mistake in sequencing can result in costly errors that could lose your team time and resources.
This is especially important to consider if the sample you’re looking to sequence is finite or irreplaceable such as patient samples. This is another reason why researchers are outsourcing their work to Sampled, as our highly trained experts are able to help you with experimental design and reduce turn-around-times.
2. Compliance with Clinical Trial Regulatory Bodies
Navigating the regulatory landscape is a daunting challenge for pharmaceutical companies conducting clinical trials. Our GIAB alleviates this burden by adhering rigorously to regulatory guidelines and industry best practices. For example, regulatory bodies such as the FDA require access to a wide range of data from cryostorage temperature logs for samples that were transported between sites to genomic data. If your data is unreliable, inaccurate or does not comply with their rules and regulatory standards it could spell disaster and delay the product’s release.
Outsourcing cryogenic storage to our GIAB, ensures samples are stored under regulatory-compliant conditions, facilitating smooth regulatory review processes. This is because our team of experts are trained to follow the latest SOPs that conform to processes laid out by regulatory bodies such as the FDA. Not only will your sample’s integrity be preserved for years to come, but they will also meet the requirements laid out by major regulatory bodies should they be recalled from storage for review.
3. Cost-effective and Resource Optimization
Running clinical trials, especially those involving biologics, demands significant financial resources and infrastructure. Sampled’s GIAB offers a cost-effective solution by streamlining sample management processes and optimizing resource utilization. By outsourcing sample handling and analysis to Sampled, researchers can minimize overhead costs associated with in-house biorepositories (which can be prohibitively expensive in labs based in major cities) and focus their resources on core research activities, accelerating the pace of drug development.
Likewise, by outsourcing research to our trained experts, researchers can save on overheads associated with hiring and training new staff which saves on capital expenditure and time. Similarly, since Sampled is a service partner with many major platform manufacturers such as 10X Genomics, Illumina, Olink, PacBio and Twist Biosciences, researchers no longer need to purchase costly platforms. Instead, they can work with Sampled’s experts to ensure their samples are analyzed in the manner they wish without having to spend time optimizing multiple platforms and maintaining them.
4. Centralized Sample Management
One of the most significant advantages of Sampled’s GIAB is its centralized sample management system. By consolidating samples from multiple clinical sites into a single biorepository, our GIAB facilitates seamless collaboration and data sharing among researchers. This centralized approach not only enhances efficiency but also ensures sample consistency and uniformity, mitigating variability and improving the reliability of research outcomes.
By taking a consistent and uniform approach to sample storage, management analysis and kitting, researchers can significantly reduce the risk of generating results that are not reproducible. In turn giving researchers the confidence that the results they are seeing are not only accurate but reproducible.
5. Enhanced Data Security and Quality Control
Data security and quality control are paramount in clinical research, especially when dealing with sensitive patient information and biological samples. Our GIAB employs stringent protocols and SOPs to safeguard data integrity and confidentiality. From robust data encryption to real-time monitoring of sample conditions, Sampled prioritizes data security and implements rigorous quality control measures at every stage of the sample lifecycle.
In conclusion, Sampled’s GIAB stands at the forefront of innovation in clinical trial management, offering researchers a comprehensive solution for handling, storing and analyzing complex biological samples. With our expertise, regulatory compliance know how, cost-effectiveness and centralized sample management, we are poised to revolutionize the way clinical trials are conducted in the era of biologics dominance. Ultimately, helping researchers to unlock new insights, accelerate drug discovery, and improve patient outcomes.
Speak to one of our experts today to learn more about how we can help your clinical research
