The key to a successful outsourcing model is understanding your current and future biospecimen management needs. Biospecimens may be collected for study endpoints or they may be stored until that moment when scientific discovery hinges on biomarker investigation. This presentation will provide an overview of specimen lifecycle strategies that will support a cost-effective outsourced model in a manner that enables flexibility and speed in getting biomarker biospecimens to analytical laboratories.

Sample-level consent management is a critical component of clinical trials, especially follow-on and translational research. Best practice recommendations suggest that sponsors should use a configurable system to define a flexible and manageable set of attributes at the study, country and site levels that can be applied to all samples collected over the duration of the trial. 

Effective management of gene therapy trials often requires innovative operational approaches. Biospecimen and associated meta-data journeys can be complex in their initial study start-up and may necessarily deviate from original plans due to rapidly evolving trial designs. Being able to pivot activities based on current operational needs, rather than conventional clinical trial practices, is key to succeeding in these types of trials. Building relationships and aligning expectations with vendors and sites throughout the trial is essential to accomplishing this. Presenters will share experiences and insights from a clinical sample management perspective of operational challenges in the implementation of immune-oncology trials.

Genomic and genetic testing in clinical trials bring up a set of specific challenges. This presentation will feature some operational and logistical solutions for scRNAseq in clinical trials, starting from sample collection all the way to the data analysis and storage.

For decades, tumor biopsies have been used to diagnose and guide treatment; however, we are entering a new era where circulating tumor DNA (ctDNA) in the blood may provide a substrate for replacing long standing tissue-based assays. But, operational obstacles remain if we are to incorporate ctDNA testing in clinical trials as the field moves from exploratory/RUO testing to using ctDNA as a CDx assay, for enrollment, and stratification.

Labconnect continues to lead the industry in clinical trial virtual sample management. The difficulties of sample collection/logistics in advanced therapy studies require a detailed sample management plan. Topics will include key solutions for today’s logistical challenges, leveraging technology and people to reduce risk of sample loss, understanding the criticality of early planning in logistics with an emphasis on involving key experts in sample management for site selection and protocol design.

What You’ll Learn: Getting the right sample to the right researcher at the right time is paramount in meeting clinical research timelines. Doing so while decreasing overall cost, protecting valuable inventories, and increasing sample utilization is key to comprehensive clinical sample management. Learn how focused sample storage and management can help you achieve these goals and accelerate your clinical research.