Innovative Services to Meet the Unique Needs of Advanced Therapeutic Clinical Trials
At LabConnect, we understand that cell and gene therapy, immuno-oncology, and rare and orphan disease trials have unique requirements that are not readily addressed by traditional central laboratory services. To meet these needs, we have established a new division – Advanced Therapy Services – that combines dedicated project management support with our analytical capabilities, real-time sampling, product tracking, global sample processing, and logistics management services.
Advanced therapy trials are characterized by protocols that include an extensive collection of samples requiring specialized processing and cryopreservation. And, with over 10 years of experience providing sample tracking and project management services for some of the world’s most innovative therapies, LabConnect is the preeminent provider of central laboratory support services for logistically and analytically complex studies.
Each trial is staffed with a dedicated project support team that includes:
- A lead project manager with advanced therapy experience
- Expert biospecimen manager(s) for sample and product tracking
- Scientific project managers for technical and analytical oversight
- A data management specialist
- Logistics project manager(s)
As clinical development for advanced therapies is adaptive and inherently changing, our project staffing model enables us to provide a level of support that is both responsive and flexible. We are focused on your patients, your samples, and the success of your program.
Customized scientific/technical support
LabConnect’s diverse menu of services can be customized to meet the unique needs of your advanced therapeutic clinical trial
Expert scientific and technical support is available for all studies awarded to LabConnect. Our scientific project managers will review your trial protocol, recommend testing to be performed, and identify the best-specialized laboratories to support your trial based on their experience.
Throughout the trial, scientific project managers provide technical and operational oversight of method validations/transfers and bioanalytical testing.
Specialized sample collection kits are designed to help simplify complex collection procedures while meeting the needs of your study and samples. Our in-house kit-building team will provide the supplies you need—everything from collection to storage—and ensure that the supplies and shippers are easy to use at the site level.
Our proprietary SampleGISTICS™ system supports sample tracking from the point of collection and enables us to virtually access samples on a worldwide basis. This process allows for real-time reconciliation of subject demographics. The SampleREACH™ portal provides you with visibility into the status of all your study samples.
Our data management portfolio includes nonstandard services such as complex data integration. We have well-established processes for standardization and restructuring of laboratory data from multiple databases into a unified data file format.
Our local laboratory standardization process simplifies the entry and monitoring of local lab data. Our approach reduces data entry delay and enables greater visibility of local lab results. This improves your ability to identify safety signals, manage toxicity, and adjust dosages—all of which are critical in advanced therapeutic trials.
LabConnect is your connection to confidence.
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