Successful pharmaceutical production starts with trials that are well supported in the lab and the supply chain.
To initiate, conduct and complete clinical trials, successful supplies delivery is critical. It is obvious that investigational medicinal products (IMP), non-IMP ancillary supplies and equipment must be delivered successfully to sites and investigators. However, the growing complexity and global reach of clinical studies have increased the challenges sponsors face in managing and optimizing their supply chains.
Significant benefits can be achieved when the supply chain is planned in advance and information flows are transparent. Today’s clinical trial supply chains are constructed around two principle pipelines and two major ideas:
- Information and material flow
- Investigators are not your supply chain’s end point and neither are patients.
The clinical supply chain that starts with research and development and manufacturing no longer ends with the investigator dispensing medication to patients. After medication has been dispensed, samples are collected from patients for analysis. Data generated from those samples must be delivered to the sponsor or CRO for further analysis, while unused medication must be returned or destroyed.
Today, the supply chain includes the movement of information and products. At every step of the supply chain, information flows upstream to the sponsor or downstream to the investigator, patient, and back. In the consumer world, companies such as Amazon have built massive depots around the world that are stocked with thousands of products.
Many items can be ordered for next-day delivery – something that was unthinkable just a decade ago. Amazon has been successful in part because of its flexible, just-in-time (JIT) supply chain that leverages information technologies to alert suppliers where and when their products are needed and in what quantities.
Your Clinical Supply Chain is Vulnerable
Sponsors are challenged to create clinical supply chains that originate from a single location and deliver medications across borders to regional depots for local distribution requiring varying storage conditions and controlled temperatures that range from -20 to 25 degrees Celsius.
Matching supplies while balancing the uncertainty of patient recruitment, along with the demands of regulatory bodies and expiration dates can be a difficult endeavor. Between manufacturing and administration to patients, many things can go wrong. For example:
- Regulatory import authorities may not agree with the value declared for a product on the pro forma invoice. If the value is increased, cost of duties increase, potentially impacting overall financial costs of a study.
- In a major Latin American country, blood drawn from patients is typically exported outside the country for analysis. Regulatory and customs authorities may not agree that an export license is required.
- One Eastern European country requires delivery within five percent of the estimated necessary medication. Underestimating needed supplies because trial enrollment is more successful than anticipated delays the study and forces a reapplication with regulatory authorities before proceeding.
- Certain countries forbid exporting a medication after it has been imported. Over-estimating trial enrollment and ending up with fewer patients requires the product to be destroyed, which in turn will impact the study cost.
Security by Decoupling Information, Early Planning
Predictive forecasting can determine where investigators are most likely to recruit patients for a study. This strategy decouples information upstream from the supply chain, enabling as many members as possible to access supply data as drugs are manufactured, labeled and delivered.
Information flows from sponsor to investigators and back again. As patients are recruited, regional depots that supply multiple countries are stocked to establish a strategic inventory that can serve as a buffer between each side of the supply chain.
An effective way to improve this information flow is JIT labeling innovation. As previously mentioned, Amazon has created a flexible, JIT supply chain that assures products are geographically available where consumers are ordering. JIT labeling creates a flexible supply chain, with labeling being performed at the latest point in the distribution process in responding to changes in the number of patients recruited, as well as to variations in import, export, and regulatory requirements.
In the past, product labels were created for each country. With JIT labeling, product labels can remain generic and postpone customization, thus eliminating excess waste. Regional depots can print labels with variable specific data to multiple countries so that medical kits are only sent to countries that need them.
As tandem with protocol development and study feasibility, sponsor and CRO supply managers must plan effective supply chain strategies that integrate the following:
- Logistics and distribution strategy
- Manufacturing and labeling
- Ancillary supplies and equipment
- Laboratory samples and analysis
- Returns and destruction activities
- Country-specific regulatory knowledge
- Information flows
By assuring information flows freely up and down the supply chain, sponsors, CROs, supply managers and investigators can operate much more effectively. This requires replacing the functional silo approach – in which the flow of information is less transparent – with an approach in which the free flow of information can improve patient outcomes through a smoother operating supply chain. This also signals a shift from a competitive to a cooperative teamwork model.
Since investigators not only administer medications but also serve as the frontline for information on study progress, involving them earlier in trial planning is key to transparent information flow.
Clinical trials supply chains are constructed around two principle pipelines: information flow and material flow. CROs will see significant benefits through a well-planned clinical supply chain strategy that takes into account the regulatory and import/export requirements of each country, investigators and patient population.
The use of information technologies to increase the transparency of the supply chain can reduce product waste and prevent clinical trial delays. In essence, end-to-end management of the supply chain, in a controlled manner, will enhance patient safety, supply and delivery.
This article can also be found in the October 2015 edition.