Oncology clinical trials are a complicated endeavour. Limited resources, long timelines, low patient participation rates and high insurance costs all add to the challenges. The pharmaceutical industry, sponsoring most trials, also requires full reporting on transparent processes throughout the trial. Hence, technology that can provide the required reporting while reducing people’s workloads and preventing mishaps, gives the research workers a significant boost.
About the Customer:
The Sheba Cancer Treatment and Research Center is part of the Sheba Medical Center, the largest hospital in Israel, handling over a million patients a year. In collaboration with global research groups, as well as pharmaceutical and biotech companies, the Research Center is engaged in cutting edge clinical and pre-clinical oncology research and clinical trials for the development of anti-cancer drugs.
Key Customer Challenges:
- Need to maintain and monitor in real-time, temperature parameters inside refrigerators where cancer cell samples, taken from participants in clinical trials, are stored
- Need timely reporting of alarm events, critically important when conducting clinical trials of new pharmaceutical compounds
- Transparent data reporting is required by sponsors and regulatory bodies
- Require around-the-clock data integrity to qualify for inclusion in medical journals
Existing systems are technologically disadvantaged by not being connected to the main hospital network, requiring all laboratory data to be manually collected and entered into the computer- Extremely sensitive materials, easily prone to damage during storage and transport
- Both patient and pharmaceutical sponsors have strict confidentially requirements
- Budget and resource restrictions impact an already overstretched medical staff
DaqLink and MicroLogPRO Implementation:
The DaqLink DBSA710 with internal temperature (-20 to 50 C˚) monitoring system was implemented in the laboratory refrigerators where cell samples from participating patients were stored. The DaqLink automatically sends alarm notifications if thresholds are crossed, with each technician receiving unique alarms that relate only to their unit. Data is automatically downloaded to the administrators’ PC via USB connection. The DaqLab software reporting facilities allow data to be compiled for inclusion in articles published on the medical trials, as well as the documentation sent with each sample’s transportation.
The MicroLogPRO compact 10-bit portable data logger tracks the shipments of sample skin cells as they are transferred to the sponsoring pharmaceutical company abroad. The MicroLogPRO can gather up to 52,000 samples allowing frequent data collection with a higher sampling resolution for accurate and reliable data readings over longer journeys. On arrival at the destination, stored data is exported to excel. (Note: the newer version MicroLog PRO II can also automatically email the data report back to the sender in PDF format.)
Measurable Results:
- Reduced pressure on medical staff – DataNet automated data delivery streamlines working processes and allows research and medical staff to focus on patient care and data analysis.
- Secured sample integrity – MicroLogPRO long-term storage and shipping monitoring, reduces contamination and spoilage both in the lab and during transport, thus minimizing delays in the trial and incidences of repeat sample research.
- Removal of data errors – aligning the entire research process through the technology chain with international standards. This also includes eliminating the possibility of transcription and data selection errors and quickly identifying adverse events during storage & transportation to the sponsor’s country.
- Technology upgrade – the Fourier solutions have aligned the entire department throughout the technology chain with international standards.
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Article courtesy of Fourtec.
