Clinical Supply Chain with a Successful Technological Leverage

In the last decade, pharma companies have raised a toast to success with significant progress and groundbreaking achievements in every area from manufacturing and R&D to the distribution and delivery, in addition to maintaining high standards of drugs safety and quality.

However, the several issues are creating ripples in the clinical supply chain management and they are expected to take a bigger shape in the future. It’s a sign delivering the right medicine to the right patient at the right time and at the right cost would become difficult when there is no plan right away. The challenges can’t be overlooked and things must be planned with a proactive approach.

But, the planning is everything and plan is nothing.

So why not take an in-depth view of clinical supply chain challenges and start planning leveraging futuristic technologies, including IoT, artificial intelligence, the blockchain, ERP, auto-driving trucks, and RFID chips that positively improve the performance.

Let’s dive in!

• Regulatory Pressures

In the present days, distributing the medicines to other countries is not as simple as creating a list of the number of drugs required, and then shipping them after sticking a packaging slip. Checking the internal political and regulatory climate of the countries for clinical trial testing and drug distribution is all-important. The reason is every country has its unique drug distribution policy and regulations and that is even changing frequently. Strictly adhering to the annex changes worldwide is absolute for the pharmaceutical companies, but making sure the movement of the drugs in different countries meeting all the compliances is tricky, tedious, and time-consuming task.

The solution: Adopting the good manufacturing practices (GMP) can help as it assists in determining whether the drugs in the supply chain is handled and controlled as per the quality and safety standards or not. It ensures all the hygiene practices and preventive measures enforced by the FDA are taken into consideration that makes the drug safe for human consumption. The ERP solution takes care of GMP compliance with batch ticketing, formula management, quality control testing, and regulatory reporting in an automated fashion.

• Poor Operational-supply chain team communication

In the course of years, the velocity of clinical trials, breadth, and scope of clinical trials, approval of medicines, and the number of geographical areas to distribute the drugs have increased, this, in turn, has made the supply chain fragmented and distribution network complex. In the whole process, the pharma company avoids teaming up with many partners in order to not bear the headache of dealing and coordinating with multiple contractors. However, finding a third-party manufacturer that becomes a one-size-fits-all solution (Providing all the resources and tools to have better visibility, complete documentation, assuring quality, and offering A-grade service) for the pharma companies is difficult.

The solution: The ERP tool reinvents the complete process with improved connectivity and collaboration. All the supply chain partners bring to a single platform that consolidates fragmented supply chain and enable centralized planning. It acts as a liaison that integrates all the clinical operations from manufacturing to the distribution that helps all the stakeholders work in rhythm with no communication gap and lack of visibility.

• Infrastructural challenges

When the stock moves from manufacturer to the patient, the drugs demand variability and difference in geographical areas exists, which pops-up infrastructure concerns due to temperature variation, inadequate power supply, improper storage, and poor transportation network. These challenges deepen the manufacturer’s woes as they negatively impact the quality and effectiveness of the drugs, supply chain performance, and throughput.

The solution: The challenge can be overcome by powering the clinical supply chain management that’s a part of clinical trial software where the predictive analytics provide a bigger picture of the issues ahead of the time so that high cost and negative performance can be prevented.

• The packaging concerns

Maintaining the integrity of drugs during manufacturing and distribution is all-important to ensure that the drug remains intact and stable. During transit, the shipment is exposed to a wide range of temperatures and also, there exist possibilities of unforeseen events such as natural calamities, or sudden changes in the climate. Here, packaging of the drugs plays a vital role in protecting the drugs integrity. But, labeling, package designing, and dispensing decisions are painstaking.

The solution: The cold chain shipping has answers to it. Under the cold chain process, it’s ensured that the required temperature is maintained so that the drug while in transit doesn’t lose its efficacy and remain safe, secure, and effective, no matter from which mode of transit it’s distributed and reached to the patient. With real-time temperature monitoring capabilities, the temperature of shipping stock can be viewed anytime, anywhere. Moreover, the packaging and dispensing can be simplified with patient-compliant and patient-focused packaging, and use of the low number of packaging designs, which protect the drugs from damage and the environment, enable ease of use, decrease overages, and allow the maximum use of the warehouse space.

• Lack of visibility

The one more result of the complex supply chain, non-integrated model and a large number of vendors is poor visibility into the inventory and the service levels. The non-visibility often bring serious issues such as drug on-demand is out-of-the-stock, the threat of counterfeit, or inability to meet the unexpected demands and which results in the loss of a sale and revenue. Besides, the approach of “Buy Big and Buy Early” results in expensive expiry and write-offs that causes heavy monetary losses to the companies.

The solution: The pharma ERP solution could bring end-to-end visibility into the supply chains which eliminate the problem of understock or overstock inventory and delivery of the wrong products or services at the wrong time. The sheer transparency illustrates where the products are and where they are headed that prevents inventory losses. Implementation of the IRT system also helps because it sends alerts for inventory levels, the drug in trials, and what’s happening inside depots in an automated way.

• No plans for emergency

Massive tornadoes, Hurricanes, or thunderstorm when hit the Midwest cities, all of the IP get lost or damaged, which means the patient who was actively on the drug, enrollment that’s not planned, and unplanned resupplies would potentially impact the clinical trials.

The solution: It can be avoided when things are done differently, such as IP micro-management, drug redistribution, accelerated unplanned resupply, and holding the patient enrollment through effective supply planning and forecasting strategy, and precise crisis management.