Background: A mid-sized biotech had an upcoming Phase 1b clinical trial with clinical sites in Europe and the testing labs in the US.  The biomarker team was looking to solve three challenges:

  1. Expediting the collection, processing and analysis of the biomarker and PK samples.  The study team wanted results of the assays quickly so the data could inform a design change (protocol amendment) prior to enrolling additional patients.  They also wanted to avoid delays due to discrepancies discovered by data management resulting in queries that needed to be resolved downstream.  They wanted real-time monitoring and reconciliation of sample data so the testing labs could run the assays as soon as the samples were received.
  2. Managing sample logistics if they were to bypass the central lab.  The samples needed to be shipped from the sites immediately to a testing lab to be analyzed within the protocol required window.  So, there was no time to send samples to a central lab first for accessioning or any logistics help.  An added concern was that the clinical sites were located on a different continent from the testing labs, so customs and other transit delays could contribute to delays and lack of visibility into sample status for the sponsor.  
  3. Ensuring data integrity.  The study design included complex biomarker processing within very short time frames, requiring the processing at the clinical sites before shipment to the testing labs.  Unfortunately, the clinical sites lacked specialized lab and sample processing capabilities, which provided additional risk to data integrity.  

Solution Overview: 

– TruLab smartphones were deployed at the clinical sites in Europe to scan the samples in real- time as they were collected and processed, effectively accessioning the samples in real-time.

– The smartphones were also deployed at the receiving PK and biomarker testing labs in the US to acknowledge receipt and condition of the samples.

– The TruLab services team monitored the sample procedures in real-time to ensure protocol compliance and reconciliation was performed within hours, as opposed to the typical days, weeks or months.

– The clinical site staff annotated  the exact reasoning for any processing steps or collection issues within TruLab, which eliminated downstream confusion for the testing lab, sponsor and CRO.  

Impact:

  1. Expedited samples analysis.  Skipping the step of sending the samples to a central lab sped up the process for results and also eliminated a typical lengthy query process.  In fact, using the TruLab technology prevented handling issues and reduced downstream queries by close to 80%.  With query delays eliminated, the sponsor was able to receive results faster and could make changes to the study prior to enrolling the next cohort.  And they were able to make an early go/no-go decision on the program.   
  2. The sponsor was able to track logistics in real time.   Because accessioning was done in real-time with TruLab, the sites could ship the samples directly to the testing labs and skip the central lab, saving valuable time to process the samples in the required window.  In addition, the sponsor could have visibility into samples and their status and location at any time.  Further, TruLab’s transit monitoring also flagged customs delays and provided an opportunity for the sponsor and CRO to contact the courier to add fresh ice to the shipment.  The testing labs also used the TruLab devices to confirm receipt of the samples which allowed turnaround times to be monitored by the sponsor.   
  3. The study team could remotely monitor and ensure data integrity.   Many of the typical handling errors were prevented because the TruLab mobile devices forced a step by step process for the clinical site staff.  For any issues that occured (such as collection out of window,  improper processing, or other handling errors), the sponsor was able to see these in real-time and intervene or retrain staff before the problem became chronic.  The clinical site staff also had a way to annotate each sample down to the aliquot such that any notes could live with that sample to eliminate downstream querying.  

Conclusions:

– At the sites, the adoption rate of the TruLab technology was 100%.  

– The clinical site staff saved 2+ hours per shipment of samples using the shipping manifest automatically created by TruLab.  This way sites didn’t need to manually populate hundreds of samples, one aliquot at a time, into an excel shipping manifest.

– The testing lab commented on how, for the first time, the shipping manifests (auto-generated out of TruLab) matched the actual contents of the shipments.  

– The sponsor’s biomarker team had visibility into the sample processing and could see when steps were not followed or collection windows were missed.  The sponsor commented on how it was the first time they have ever had visibility into data integrity on processing and collection of the samples.