The complexity of clinical trials continues to rise. New biomarkers for safety and efficacy continue to emerge, and new types of information – such as genomic profiles – have become critical to submissions for drug approval. Against this dynamic backdrop the central challenge facing trial sponsors remains the same: the need to bring together diverse data sets, draw meaningful insights from them and act quickly to maximize return on investment.
Covance and Global Specimen Solutions, Inc. (GSS) have announced a five-year strategic alliance that gives our clients access to a comprehensive and integrated solution that includes GlobalCODE®, snapTRACKTM and GSS wraparound services. This will enable near real-time data cleaning across clinical trial data sources which allow interventions to be made during the clinical trial, impacting overall trial execution and data validity. This also allows cross-protocol, cross-program analytics which provide context for data results, assuring robust clinical trial design and operational excellence.
GlobalCODE® is a proprietary data management system that will enable access to live specimen data and analytics, whether from a single study or across multiple study protocols and patient populations. This system will accept data from our central labs and the external labs that support the clinical trials. Further, it provides management of informed consent and material transfer agreements so that qualified samples can be identified and used in multiple studies. The product snapTRACK™ is a point-of-collection mobile tracking application that will follow sample lifecycles from collection through testing and destruction, providing visual records of the sample state upon collection.
Specimen Tracking: A Key to Unlocking Data Insights
Many of our clients have experienced a late-stage event that requires quick decision making and a need for actionable insights. Others are familiar with having multiple ongoing studies that would benefit from easier ways to perform cross-trial analytics. The common denominator is the need for more and better data to speed compounds toward regulatory approval. The data exists already, but in many cases is compartmentalized into silos, and stored in incompatible formats, making it difficult to draw actionable insights. A new approach is necessary that will allow aggregation of all specimen data into a single, easy-to-query source.
“Our collaboration with GSS enables our clients to track their samples end to end with informed consent management and to see truly unified views of their biomarker data for the first time – bridging data gaps and silos. This will allow better decision making and insights from the diverse inventory of samples collected across indications over time. GSS products and services will help fulfill our mission to improve health and lives by bringing innovative medicines to patients faster,” commented Paul Kirchgraber, MD, MBA, vice president and global general manager for Central Laboratory Services.
Taking the Long View
These technologies support sponsor stakeholders, such as clinical teams, by giving them access to novel in-life actionable views of specimen data across all vendors, optimizing trial execution and improving compliance, while speeding time to data lock. For translational medicine groups, and biomarker assay developers, the ability to analyze results across protocols and generate views of relevant specimens over an entire pipeline can result in a dramatic increase in the value of stored specimens. By reducing the need to acquire characterized research specimens, pharma companies can save millions of dollars per year and accelerate the pace of biomarker development and testing.
We will offer the service for new clinical trials, as well as retrospective (closed) trial data, enabling comprehensive views of biomarker results across populations and time. The ability to perform such longitudinal queries will open up new avenues of discovery into drug candidate performance and may offer unprecedented ability to identify and access stored specimens and results as needed. Clinical trial sponsors will now have access to unique presentations of data, allowing them to take action during the clinical trial, proactively responding to specimen collection issues or enabling new testing and analyses to support the final regulatory submission.
Proven Value from Scalable Data Integration
In considering our approach to this industry challenge, we spoke with many pharmaceutical companies. Several reported attempting to craft in-house systems to accomplish this data integration, but they were stymied by high startup costs or difficulties in scaling up to match the size of their pipelines. By offering this capability as a Software as a Service (SaaS) model, we are breaking down the startup cost barrier, ensuring scalability, and speeding adoption of an integrated data architecture.
We are excited to offer GlobalCODE®, snapTRACK™ and other GSS Services as part of our portfolio, because we understand how valuable it can be to access previously siloed data sets to generate new insights. We will be delivering these solutions as SpecimINSIGHT™. For example, in recent years we introduced Xcellerate® to optimize investigator site selection based on the largest existing database of clinical trial testing results in the industry. Now, with SpecimINSIGHT™, we will bring valuable new insights into clinical trial testing for the first time, allowing the integration of previously-separate data streams such as specimen lifecycle tracking, analytical results and consent.
Are you struggling with integration of your clinical trials data? Have you been frustrated with the difficulties of managing specimen lifecycles and identifying useful biorepository samples? Learn more about SpecimINSIGHT™ solutions that will break down the data silos and accelerate the progress of your trials.