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With the ever-increasing need for more accurate data logs in modern clinical trials, the old-school method of manually updated data logs faces many challenges. Thankfully, kit-level monitoring thrives where manual data collection fails. Read more to find out how kit-level monitoring is critical in clinical data collection.



The Main Challenges of Manual Data Collection


Clinical trials put enormous reliance on accurate data collection to prove the reliability of the end result. Having correct data at the right time is vital in human health research and perhaps more critical than in any other sphere of research. Consequently, the same data collection proves to be the ultimate source of frustration and disappointment in clinical trial monitoring.

Poor data collection and parameter monitoring during the trial and on transit contribute to most failed trials.

As a result, there is an ever-pressing need to acquire more advanced data collection methods that are free from the limitations faced by the traditional manual methods.


The traditional approach to data collection focuses on manual updates on data logs or the use of Excel spreadsheets, which are still updated manually. However, ELPRO recognizes that the traditional manual approach faces several challenges that render it ineffective in light of the changing clinical supply chain. As a result, ELPRO advocates for kit level monitoring that overcomes all the challenges stated below.



In a traditional clinical supply chain where the products are moved several times before they arrive at their final destination, manual data logs can be very time-consuming. Since continuous monitoring is practically impossible, only interval data collection is possible. Data is, therefore, missing between intervals, which may mean that the product has been compromised. Additionally, when dealing with a massive warehouse with a large quantity of products, it will take a lot of time to collect the data. Apart from data collection itself, a lot of time is consumed in data cleaning for analysis. If there are different storage sites in separate locations, data consolidation will be another source of headaches for the team.



Manual data collection is expensive. There is a need for personnel to facilitate manual data collection, cleaning, and analysis. The more complex and widespread the clinical trial monitoring operation, the more the human resources necessary, which translates to higher costs. Since manual techniques cannot render adequate data analysis for decision-making, data must be fed into a computerized system. That means more expenditure on personnel for data entry and equipment to facilitate data transfer and analysis.



Perhaps the most significant problem facing manual data acquisition in clinical trial monitoring is that it is prone to errors. Results must be free from any errors to guarantee quality and credibility.

Kit-level monitoring overcomes the challenge by presenting automated data acquisition that eliminates human errors.

With manual data logs, it is easy for the user to enter wrong data, mix up the data columns, or misread the logs when transferring to the computerized system. Forgetfulness and carelessness can lead to misplacement of logs or skipped intervals. All these errors will weigh negatively on the trial outcome and possibly lead to a nullification of results.



Choosing the Right Temperature Monitoring Device


Part of the data collection headache in clinical trial monitoring is temperature monitoring. There are various clinical supply chain modalities, each with unique requirements for temperature monitoring. However, one factor is common among them all. That is the need for accurate temperature logs right from the manufacturer's storage facility until the product reaches the consumer. Temperature monitoring in storage facilities can be straightforward. The challenge is temperature monitoring for products that are in transit or repackaged.


To ensure product quality is maintained within the set temperature limits during the entire supply chain, having a suitable temperature monitoring device is indispensable. Since no trial can do without a temperature monitoring device, the challenge is finding an accurate, reliable, and cost-effective device.


Consider Wireless Connectivity

Several factors make a temperature monitoring system preferable for clinical trials. One of these is wireless connectivity. The pharmaceutical industry is getting closer to the patient through Direct-to-Patient supply modalities. This has brought a need for temperature monitoring for each box of products. While warehouse monitoring is possible with a few strategically placed sensors, temperature monitoring for each individual box on transit requires more sensors. The only practical and feasible way to access data during transit is through remote connectivity. Therefore, devices configured to collect and upload data to the internet are the best options. Once the data is on the web, remote access is possible from any authorized internet-enabled device.


Continuous Monitoring Ability

Clinical trial monitoring relies heavily on temperature logs to prove product quality. Product quality cannot be guaranteed without continuous temperature monitoring. When the products are outside the warehouse, on transit to clinical sites or patients’ homes, the product could be exposed to fluctuating temperature changes which could damage the product. Therefore, when looking for a temperature monitoring device, go for one designed to provide continuous monitoring.


Chemical vs. Electronic Indicator

The choice between a chemical indicator or electronic indicator for clinical trial monitoring depends on the product's nature and shipping requirements. You may want to opt for the chemical indicator when working under a tight budget since it is more affordable. Because it does not run on battery power, a chemical indicator is preferred for products with a longer shelf life. The downside of the chemical indicator is that it cannot provide any history. The chemical indicator is only capable of providing a single result expressed by the color change or lack thereof.


On the other hand, the electronic indicator offers insight into the temperature trends during storage and transit. Therefore, it is necessary for high-end products like clinical trial drugs and therapies that are sensitive to temperature changes. With an electronic indicator, alarms can be programmed to notify the user of temperature excursions. The indicator tracks both the temperature and time of the product throughout its journey.


Kit-Level Monitoring


The clinical supply chain is changing significantly in the wake of advancing pharmaceutical therapies geared towards personalized health care and user-specific gene therapies. Since more manufacturers opt to reach the patient directly and avoid the classical supply chain modalities with its numerous intermediaries, the traditional approach to data collection is proving ineffective and uneconomical. As a result, kit-level monitoring is gaining momentum as the most efficient data collection and product monitoring technique.


While product monitoring has good production and distribution guidelines before it reaches the clinical site, there are no guidelines for distribution beyond the clinical site. However, recent innovations in clinical trial monitoring have pushed regulatory authorities to consider, with utmost keenness product quality monitoring during the last mile. As a result, kit-level monitoring is becoming the best technique since it offers reliability, continuous remote monitoring, and easy data access. Additionally, it is compact and economical.


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In kit-level monitoring, sensors are placed into individual product packages. Thanks to modern technological advancements, minute sensors fit into small boxes and provide real-time readouts. These miniature sensors can provide continuous data logs for products both in storage and during transit. With kit-level monitoring, the quality status of the trial product can be identified at the press of a button. Therefore, monitoring capabilities are available beyond the warehouse and into the patient's home.





To remain competitive in this time where clinical supply chains are dramatically changing, you must make drastic changes to your clinical trial monitoring techniques. Traditional methods lag behind kit-level monitoring in reliability, wireless capability, accuracy, and remote data availability. It is about time to jump ship and join kit-level monitoring with its immense benefits in cost saving and product credibility. ELPRO offers fantastic monitoring solutions suitable for any clinical trial monitoring need.

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