Globalised clinical trials face a number of challenges when it comes to sourcing, supplying packaging and labelling and distributing clinical trial supplies and comparator products
Supply chains are facing disruptions when importing and exporting medicines, maintaining regulatory compliance across countries, and controlling temperature conditions.
These supply chain inefficiencies can prove very expensive and more importantly, put patient safety at risk. The comparator sourcing supply chain requires expert planning and management to ensure successful delivery.
Successfully managing the clinical trial supply chain helps to improve efficiencies, minimise risk and maximise cost savings.
Here are 5 reasons why clinical trial supply management is crucial in today’s clinical trial climate:
In a complex clinical supply chain, it only takes one element to fall out of place for the whole process to be negatively impacted. These inefficiencies most often include manufacturing delays, quality control, temperature deviation, changed import and export regulations, and site storage conditions.
Proactive management identifies opportunities where the supply chain can be optimised and puts processes in place to improve efficiencies and anticipate challenges. This ensures consistent quality assurance processes, storage and distribution solutions and temperature controls are implemented; remaining compliant with regulatory requirements at every stage.
Successful clinical trials need effective supply chain management procedures. This ensures risks are identified and managed in a timely manner, and the required medication is available at the site when needed. Taking a holistic approach to assessing and managing risks prevents issues that impact the trial and the data generated.
Looking at the different phases of the study and the complexities each one encompasses is a great way to identify where risks may arise. Employing a 6 step risk management process - identify, evaluate, control, communicate, review and report - ensures costs and trial data can be protected.
Maximise cost savings
Delays and inefficiencies can equate to significant financial loss. For example, if product acquisition is delayed, the window to package, label and distribute is shortened and there might be no medication available at the site for patients.
Calculating shipping times and costs at the protocol design level enables supply chain managers to forecast the feasibility of the study and iron out design flaws before implementing them. Knowing all of the study information, such as the countries the products are being sourced from and distributed to, can ensure the most efficient and cost-effective transport route, therefore saving money along the way.
Reduce product waste
Accurate supply chain planning reduces unnecessarily high levels of stock and avoids oversupply. Having full visibility of the number of trial participants, the dosages required and the clinical distribution sites ensures the right product reaches the right site at the right time.
By using flexible solutions, such as just in time deliveries and packaging and labelling products on an as-needed basis, companies can reduce product waste, reduce costs and prevent a negative impact on the conduct of the trial.
Maintain regulatory compliance
Collaborating with suppliers and manufacturers across the world ensures companies can leverage regulatory and country-specific expertise. Regulations are ever-changing and can differ greatly from country to country. This puts companies at risk of having their products blocked from entering the trial country or recalled entirely.
Comparator sourcing partners apply global regulatory knowledge when acquiring documentation, understanding import and export regulations, and overcoming language barriers to ensure companies remain compliant throughout the trial process.
Partnering with CSI at the protocol design stage optimises your supply chain, implements effective processes and technology. There is no one size fits all approach - we devise a bespoke supply chain management strategy that caters to your trial requirements. With more than 1000 trials successfully supplied with medicines all over the world, we have the experience, expertise and knowledge to deliver value to your studies.