In the rapidly evolving landscape of oncology research, the quest for novel treatments and breakthroughs demands efficiency, precision, and the seamless execution of various stages in the research pipeline. Outsourcing key services such as sample storage, microarrays, and sequencing can significantly support oncology-based researchers across different stages – from the initial research and discovery stage to preclinical research and, ultimately, the critical clinical trial stage.
As the world’s only Global Integrated Analytical Biorepository, Sampled are uniquely positioned to ensure sample integrity by minimizing risk to samples. Clients no longer need to risk the integrity of their samples or becoming compromised due to repeated shipment between multiple sites for analysis at third party labs before being sent back into storage. Instead, their samples are stored in the same facility as the one they are analyzed in, ensuring that they are subjected to the same SOPs, storage conditions and limited amount of handling.
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Here is how Sampled can aid oncology researchers in the first three key stages of their research by utilizing the Global Integrated Analytical Biorepository.
1. Research and Discovery Stage
Groundbreaking discoveries in oncology all start with the research and discovery stage, where researchers explore potential biomarkers, therapeutic targets, and disease mechanisms in order to exploit them. Outsourcing key services to Sampled can accelerate this stage by:
Example: A dedicated sample storage service ensures the preservation of valuable biological specimens. By outsourcing cryogenic storage to our specialized facility with CAP/CLIA accreditation researchers have access to well-preserved samples that are cared for round the clock by a dedicated team of experts working to ISBER best practices.
Utilizing outsourcing services for transcriptome analysis using microarrays or next generation sequencing enables researchers to examine gene expression at a large scale. This can uncover potential biomarkers and pathways associated with specific cancers, providing a wealth of data for further investigation.
Outsourcing next-generation sequencing (NGS) allows researchers to delve deep into the genomic landscape of cancers. This can unveil genetic mutations, the epigenetic landscape and potential therapeutic targets that may guide subsequent stages of research.
2. Preclinical Research Stage
After promising leads have been identified, the preclinical research stage aims to validate and optimize potential therapies before moving to clinical trials. Outsourcing services during this stage provides several advantages:
Outsourcing cryogenic storage ensures that preclinical samples, including cell lines and animal tissues, are securely stored in facilities equipped with backup power, up-to-date SOPs and trained staff. Our centralized Global Integrated Analytical Biorepository facility minimizes the risk of sample degradation and ensures uniform handling as well as correct documentation and recording for request by governing bodies such as the FDA etc.
Outsourcing next generation sequencing services for comparative genomic and transcriptomic analysis between normal and cancerous tissues helps identify potentially important variations associated with tumor development. This aids in validating potential targets and stratifying patient populations for future clinical trials. Similarly, Sampled can provide access to cutting edge single cell and spatial RNA sequencing platforms to provide a global view of gene expression patterns, aiding in the identification of potential biomarkers at high resolution as well as therapeutic targets.
Targeted sequencing allows researchers to validate candidate genes identified in the discovery stage efficiently. This stage may involve screening a larger number of samples to confirm the relevance of genomic alterations and assess their potential as therapeutic targets. Sampled can scale our services to meet your needs allowing you to be agile and able to meet shifting deadlines.
3. Clinical Trial Phase
Moving into the clinical trial phases requires meticulous planning, adherence to regulatory standards, and precise execution. Outsourcing critical services can streamline this process and ensure that your research meets the expectations of regulatory bodies.
Sampled offers sample storage services that either meet or exceed the industry standards as set out by the College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA). This ensures compliance with regulatory requirements for clinical trials since our facilities are equipped with scalable storage solutions which can accommodate the increased volume of patient samples while maintaining the necessary levels of quality control.
Utilizing outsourcing services for transcriptome analysis in clinical trials allows for the identification of predictive biomarkers. This information is crucial for stratifying patient populations, optimizing treatment strategies, and improving the overall success rate of the trial.
Outsourcing real-time sequencing services during clinical trials enables researchers to monitor genomic, epigenetic and transcriptomic changes in patients over the course of the study. This dynamic approach allows for adaptive trial design, optimizing treatment protocols based on evolving insights.
4. Regulatory Review and Approval
The difference between a drug/therapy gaining regulatory approval or being delayed can lie in the details that are involved in the meticulous review process. Here, 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 Global Integrated Analytical Biorepository, 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.
Sampled has a proven track record of working with large and smaller biopharmas for many years and has aided researchers in meeting regulatory requirements for many studies including those based in oncology.
By outsourcing sequencing requirements to Sampled, researchers can ensure that the genomic data generated for regulatory submissions is accurate, reliable, and complies with regulatory standards.
5. Manufacturing and Scaling Up
Outsourcing microarray services to Sampled allows researchers to scale up gene expression profiling efficiently, a critical step in understanding the molecular intricacies of oncology. We have the resources to scale to meet your needs, which removes any need for you to find capital expenditure to purchase new platforms, hire new staff and maintain projects. This means you can focus on the research that matters most and let us do the heavy lifting on your behalf.
Sampled are specialists when it comes to providing stability storage services. Our experts have worked in stability storage many years and adhere to ICH guidelines, providing reliable data on the stability of drug candidates and packaging during the manufacturing and scaling-up stages.
Utilizing our lifecycle management services streamlines the handling and tracking of samples, ensuring integrity and compliance throughout the manufacturing process. We have a bespoke kitting and logistics service that is tailored to your needs including those clients who need logistical support that is compliant with regulatory bodies for clinical trials.
6. Post-Market Surveillance
Outsourcing bioinformatics services to Sampled enables researchers to handle vast datasets generated during post-market surveillance efficiently. This aids in identifying trends, potential safety concerns, and optimizing treatment strategies.
Sampled also provides cell services including iPSC cell line generation, PBMC isolation and CRISPR gene editing services allowing researchers to conduct in-depth studies on cell behavior during post-market surveillance, contributing valuable insights for ongoing safety assessments.
We offer researchers the ability to continue sequencing their samples during post-market surveillance to ensure ongoing monitoring of genomic variations and potential resistance mechanisms, aiding in adapting treatment approaches as needed. The benefits of this are that it provides reliability and accuracy to the data generated as the same platforms, SOPs, methods of investigation have been used to sequence the samples before, during and after the drug has gone to market.
Conlusion: Outsourcing Oncology Research Services to the Global Integrated Analytical Biorepository
In summary, outsourcing services to Sampled offers a myriad of advantages throughout the research pipeline, from the initial stages of discovery to the critical stages of clinical trials. By leveraging specialized expertise and cutting-edge technologies within our Global Integrated Analytical Biorepository, researchers can enhance the efficiency, accuracy, and success of their endeavors, ultimately contributing to the advancement of cancer diagnostics and therapeutics.
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