How Contract Research Organizations Optimize Cold Chain Operations During Clinical Trials

In the United States, 165,000 clinical trials each year are carefully designed and conducted to test the safety and efficacy of drugs before they are approved by the FDA. Because many medications, in particular vaccines, must be stored and transported in refrigerators and freezers, an intricate and complex cold chain is required to ensure they are continuously maintained within their proper temperature ranges.

Pharmaceutical and biotechnology companies frequently hire Contract Research Organizations (CROs) to manage clinical trials through all their stages. Rising pressure on these companies to be first to market can fast-track research to control costs, which also potentially adds greater risk to the integrity of experimental samples throughout the research lifecycle.

To mitigate risks by controlling the clinical trial’s cold chain operations, CROs must monitor environmental conditions, execute corrective actions when excursions in temperature occur, and analyze in-depth data gathered at each link in the chain to optimize efficiency, safety, and compliance. Among its many responsibilities, the CRO is charged with preventing the loss of clinical samples, which not only destroys years of investments, but also delays life-saving treatments for patients.

In this post, we take a look at how CROs use IoT-enabled Sensing-as-a-Service solutions to ensure regulatory compliance and optimize cold chain operations at each point of a clinical sample’s physical journey during its clinical trial.

How CROs Ensure Regulatory Compliance During Clinical Trials

CROs play a crucial role during clinical trials. They oversee various tasks such as project management, development of study protocols that comply with regulations, selection of research sites, recruitment of patients who meet the trial’s eligibility criteria, and communication and collaboration among the company and other stakeholders, including investigators, ethics committees, and regulatory agencies. By outsourcing these functions, sponsor companies can reduce costs, accelerate timelines, and benefit from specialized expertise.

Compliance involves a commitment to ethical practices and scientific rigor, adherence to regulations and guidelines, and a focus on participant safety. To ensure the integrity and validity of research data, CROs must implement quality control measures, promptly address any deviations, and keep accurate records. Equally important, compliance is essential for facilitating the approval process for new treatments and building public trust in clinical research.

Key features of a clinical trial that CROs must manage include:

• Regulatory submissions: CROs navigate the complex regulatory landscape and prepare and submit regulatory documents. 
• Adherence to FDA regulations: CROs must ensure that clinical trials comply with a long list of rules and guidelines governing human subject protection and the conduct of clinical trials. 
• Good Clinical Practice (GCP): In particular, CROs must adhere to GCP guidelines, which provide a framework for the ethical conduct of clinical trials, in particular the informed consent of participants and the confidentiality of their clinical and personal data. 
• Monitoring environmental conditions: CROs continuously monitor the safety and integrity of experimental samples along each link in the cold supply chain, identify potential risks to participants, implement measures to mitigate these risks, and record, correct, and report any adverse events to company executives and relevant authorities.  
  
  

How CROs Manage Cold Chain Operations During Clinical Trials

Cold chain operations in clinical trials are crucial for maintaining the effectiveness of temperature-sensitive materials such as vaccines and biological samples. Sustaining cold chain integrity involves a system of controlled storage and transportation to ensure these materials stay within their optimal temperature range while stored and transported from manufacturing through administration. This system includes:

• Thermal packaging: Various thermal shippers, liners, and gel packs maintain specific temperatures during transport.  
• Specialized transportation: Logistics companies and couriers specializing in temperature-sensitive materials ensure safe and timely delivery using methods to maintain consistent temperature control.  
• Cold storage: Facilities are equipped with controlled temperature storage assets for long-term storage of materials under controlled temperature conditions, such as refrigerators and freezers. 
• Temperature control sensors: Real-time monitoring systems track temperature fluctuations and provide alerts for potential excursions to ensure specific temperature ranges are sustained (e.g., frozen, refrigerated) to preserve the quality and potency of materials.
  
  

Why Sensing-as-a-Service Is Essential for Optimizing Cold Chain Operations

A Sensing-as-a-Service solution is crucial for CROs to manage a clinical trial’s specialized inventory, maintain specific environmental conditions of samples and assets, and preserve the integrity of data collected at each stage of the trial.

Using the proper equipment is paramount when conducting clinical trials. A stock of examination, assessment, and procedural tools must always be available to maintain essential functions and ensure processes for patient monitoring, data collection, and analysis are not interrupted.

Clinical trial medications undergo specific environmental condition monitoring to ensure their effectiveness. This testing involves subjecting the medications to varying temperatures and humidity levels to simulate real-world conditions.

For example, during development of the COVID-19 vaccine, time and temperature standards were tested and established to provide requirements for different holding conditions — room temperature, refrigerator, freezer, and deep freezer. Using this knowledge, stakeholders throughout the cold chain were empowered to create the proper storage and handling conditions for medications and vaccines to maintain their efficacy.

CROs must also consider the impact of gases and oxygen exposure on the stability of medications. Exposure to oxygen can degrade certain medications, rendering them ineffective, thus requiring the use of protective packaging and storage solutions to minimize the risk of contamination.

Finally, accurate data collection and analysis are crucial for drawing valid conclusions about the efficacy and safety of new treatments. Accurate documentation and data management ensure the validity of trial results, while compliance ensures the integrity of the trial data, leading to reliable and meaningful results.

Protect sponsored clinical trials with SmartSense

Leaders of contract research organizations (CROs) must partner with reliable providers to implement the right technologies and frameworks to meet the complex needs of cold chain operations during clinical trials. Proper execution of condition monitoring, quality control, and data oversight is essential for controlling costs and mitigating potential risks of trial failure or delay.

SmartSense’s Sensing-as-a-Service solutions streamline Contract Research Organization (CRO) operations and compliance processes for clinical trials. Our advanced remote temperature monitoring and alert systems effortlessly ensure the temperature stability of sensitive medications with automatic validation.

• Laboratory temperature monitoring: Increases lab compliance visibility and improves staff productivity across all types of laboratories. 
• Automated lab temperature alerts and compliance logs: Ensure lab safety & quality control and meet FDA compliance regulations with corrective actions for exceptions. 
• Automated clinical research operations: Streamline costly, error-prone, and labor-intensive manual operations with automated monitoring and reporting. 
• Scalable temperature and humidity monitoring: Deploys easily with SmartSTART implementation services to monitor clinical trials, medical laboratories, hospitals, clinics, and pharmacies.  
  
  

With our real-time tracking and advanced sensor technology along the cold chain, CROs can ensure compliance, reduce risks of sample degradation or loss, optimize transportation routes, and plan for contingencies to minimize delays and disruptions that could jeopardize the success of clinical trials.