7 Tips to Ensure Quality and Compliance in Your Clinical Trials

Clinical trial costs have increased dramatically over the past decades. In 2004, the process of bringing a new treatment to market cost roughly $800 million on average. Now, clinical trials spanning the same amount of time can cost around $2.6 billion.

There are many contributing factors to the rising costs of pharmaceutical research, including advancements in personalized medicine and increased trial complexity. Regardless, to avoid heavy losses, pharmaceutical companies must get it right the first time. Taking the proper steps to ensure quality and compliance in clinical trials is the best way to keep patients safe while adhering to the desired timeline.

Whether you're trying to achieve compliance in vaccine trials or looking for a way to streamline your product shipments, these tips can help you ensure trial quality.

1. Design a Strong Clinical Trial Strategy

Approaching a clinical trial with a proper framework in place is vital for ensuring success. Your goal in this step should be to develop a trial process that is most likely to prove the product's effectiveness and safety.

First, determine what protocols you need to follow to achieve compliance with the applicable regulations. Then, design trial processes that match each of the FDA's four clinical trial phases. Peer review can help you determine whether you're on the right track with your trial design.

2. Establish Chain of Custody Protocols

From maintaining compliance in manufacturing vaccines to protecting data integrity during trials, a clear chain of custody (COC) plays a critical role in a trial's success.

A COC is essential for compliance with the Drug Supply Chain Security Act (DSCSA), which requires companies to track every pharmaceutical substance throughout the supply chain. It also allows you to trace any problems back to their source by tracking who has possession of a sample or product at any given time.

In the past, maintaining an up-to-date COC required lab and administrative personnel to fill out significant paper documentation. With the rise of cloud technology and automation, digital systems can now automate part or even all of this process.

3. Identify and Maintain Ideal Clinical Conditions

Part of outlining your clinical trial strategy includes identifying proper clinical conditions and how you will maintain them. 

Here is a brief list of what to monitor in pharmaceutical trials:

  • Temperature: Many pharmaceutical products must be stored at extremely low temperatures to remain effective. Temperature excursions of even a few degrees can destroy products, resulting in enormous losses. Often, extended temperature deviations are the result of supply chain issues.
  • Humidity: High ambient humidity can degrade pharmaceutical products, reducing their effectiveness. If left untreated for too long, excessive humidity can even cause some drugs to become toxic.
  • Light: Many pharmaceuticals are photosensitive, meaning direct exposure to light causes them to degrade and develop impurities. Proper packaging is essential for protecting these products against light damage.
  • Vibration: Monitoring and managing vibrations is critical during both the manufacturing and transport stages of a drug trial. Excessive vibration can cause large proteins to denature and become inactive, which means the product containing them also becomes ineffective.

Tracking the conditions your product’s experience at every stage of the trial helps ensure compliance with relevant regulations and keeps your trial participants safe. 

In addition, any potential quality excursions can be found and resolved quickly to prevent waste and keep your clinical trials on track.

4. Follow Manufacturing Best Practices

Following manufacturing best practices is essential for ensuring vaccine and medicine quality in clinical trials. Current Good Manufacturing Practice (CGMP) guidelines should be top of mind. These guidelines define the minimum requirements for drug manufacturing methods and facilities, helping you ensure your product is safe for use.

For example, if you are manufacturing medicines in tablet forms, you know that sufficient dwell time is critical for product quality. If the dwell time is too short, the rotary press will fail to compress enough air from the tablet, and the resulting product will be more likely to break apart. Following CGMP controls can help you optimize dwell time, producing higher-quality tablets and ensuring drug effectiveness.

5. Know Your Shipments' Locations

Delayed shipments can be detrimental to clinical trials, especially if the shipment vehicle encounters poor conditions. Often, en route delays result in the product being exposed to damaging conditions, which can put the entire trial at risk.

A real-time digital tracking solution should be part of your chain of custody. You can use this software to set up alerts for unexpected issues like delays, temperature increases and inclement weather, so you will always know what's happening with your shipments.

6. Enable End-to-End Visibility

Finding a solution that provides visibility to everyone both inside and outside your company holds all parties in your supply chain accountable and helps speed along manufacturing and shipment. Any information gaps in a product's lifecycle can jeopardize the integrity of your trial by making you unable to prove its validity.

A digital COC should include immutable records of all the steps a test sample or pharmaceutical product takes throughout the trial to keep everything on track. Additionally, end-to-end visibility enables everyone in your supply chain to cooperatively address disruptions — if something goes wrong, you can easily bring everyone onto the same page and find the quickest solution.

This continuous visibility allows faster “fit for use” determination at the final destination.  No need to download data from passive quality monitoring devices to check for quality excursions or check through different systems for good COC confirmation.

7. Take Advantage of IoT Technology

Equipping shipments with smart technologies such as the Internet of Things (IoT) enables you to access shipment and quality data in real time.

IoT sensors can gather critical information about each shipment, such as ambient conditions, geographical location and even product abnormalities. If anything falls outside predefined conditions, you will know right away.

These sensors can also help prevent theft and counterfeit, two major problems in pharmaceutical supply chains. Counterfeit in particular has become more common since the outbreak of the COVID-19 pandemic — knowing when your shipments are opened and by who can help you prevent falsified product from putting trial participants in danger.

Further, IoT integrations with supply chain management software help consolidate all the information these devices collect for easy access. You will have a single source of truth for your entire supply chain, so you can rest assured knowing your trial has the best chance of success.

Enhance Clinical Trial Quality and Compliance With ParkourSC

Today's pharmaceutical supply chains are incredibly complex, often including entities from multiple countries. That is why pharmaceutical companies rely on our end-to-end supply chain operations platform.

With a focus on visibility, predictive analysis, and resolution, our cloud-based solution helps prevent incidents like quality excursions or a broken COC from derailing clinical trials. Additionally, advanced tools such as digital twins and embedded intelligence allow you to proactively manage risks and compliance across your entire supply chain.

Contact us today for more information on how our platform improves pharma transport compliance for clinical trials.