top challenges sourcing pharmaceutical products for clinical trials

Conducting clinical trials is a vital component of pharmaceutical development, yet sourcing registered pharmaceutical products presents multiple challenges.

Securing a reliable supply chain for comparator drugs and co-therapies is one such challenge, with as many as two-thirds of clinical trials hinging on the successful acquisition of these critical supplies.

In 2024, a survey of 25 Australian biotechnology companies, contract research organisations (CROs), and clinical trial sponsors ranked availability, guarantee of supply, speed of sourcing, and lead time as the top challenges associated with sourcing clinical trial supplies such as comparator drugs and standard-of-care medications.

Below, explore the most significant obstacles faced by sponsors and CROs, with expert insights into how to navigate them effectively.

Adhering to regulation

Meeting regulatory compliance is an inherent challenge in sourcing pharmaceutical products for clinical trials. The mosaic of international regulations, import-export restrictions, and documentation demands vary significantly, making it essential to stay informed and often engage partners with specialised knowledge.

Tips

• Understanding regulations: During study design and feasibility, it is important to understand the specific regulations of each country involved in the trial.
• Documentation management: It is essential to ensure all necessary documentation, such as Certificates of Analysis (CoAs) and import/export permits, are in place. If in doubt, consider engaging with sourcing and logistic experts who understand each country’s requirements and can adhere to the strict regulatory standards, ensuring your trial’s credibility.

Availability – Hurdles and strategies

Ensuring the consistent availability of comparator and standard of care products is crucial for uninterrupted clinical trials. Pharmaceutical manufacturers may place limitations on the supply of products for use in clinical trials and implement approval processes in anticipation or response to high demand for certain drugs. This can lead to supply issues on the open market, impacting the commercial supply chain to hospitals and patients.

Drug shortages and supply chain disruptions can also have a significant impact on clinical trial schedules. Manufacturing obstacles, regulatory limits, natural calamities, and geopolitical factors can all contribute to these challenges.

Tip

• Robust supplier network: It is essential to understand the volume of product available from manufacturers, and how this may change over the duration of the trial. To manage disruptions to supply, it is critical to work with a partner with a diverse supplier network and tested supply chain resilience, that maintains open communication with both the sponsor and manufacturer to maintain reliable and consistent availability of pharmaceutical products.

Batch numbers and expiry dates

Forecasting drug and supply requirements accurately is critical for guaranteeing adequate inventory throughout the trial, while minimising batch numbers and securing the longest expiry.

Uncertainties in patient enrolment rates, study duration, regulatory approval deadlines and site activation present complex challenges when designing and managing clinical trials.

However, working with a specialised sourcing specialist that deals directly with the manufacturer to secure product for the duration of the trial can reduce the risk of stock shortages and supply issues associated with sourcing product from the open market. Working directly with the manufacturer can also assist with minimising the number of batches and optimise expiry dates to cater to delays or interruptions to the trial

Tips

• Evidence-based decision making: Sponsors, their CRO and supply chain managers should work closely together, employing historical data, enrolment projections, and simulation models to create accurate demand forecasts. 

• Direct relationships: Working directly with the manufacturer helps manage supply and minimise number of batches and optimise expiry dates. If in doubt, consider engaging a sourcing specialist that deals directly with the manufacturer to secure product for the duration of the trial.

Documentation

Proper documentation is critical in clinical trials, providing a paper trail that ensures compliance and facilitates audits.

Comprehensive record-keeping involves maintaining detailed records of all sourced products, including batch numbers, expiry dates, and supplier information. Ensuring that all regulatory documentation is up-to-date and accessible is essential for compliance with industry standards.

Tips

• Documentation requirements: Key clinical trial documentation required for clinical trial submissions include Certificates of Analysis (CoA) and Certificates of Conformity (CoC), often needing manufacturer approval; equivalency documents, shipping documents, and GMP certificates.

• Document access: Understanding documentation availability in the early stages of trial design and feasibility allows for informed decision making. Engage a sourcing partner with direct relationships with the Marketing Authorisation Holder (MAH) to negotiate access to required documentation.

Price

Sourcing registered pharmaceuticals for clinical trials can be costly and represents a significant portion of the trial budget. Effectively managing these costs is crucial for the financial viability of a trial and involves accurate forecasting and efficient inventory practices to minimise wastage.

Tips

• Budget planning: Budgeting should consider both expected and maximum costs to prevent overruns. According to market intelligence for some products, central sourcing can sometimes be more cost-effective than in-country sourcing.

• Funding strategies: In countries like Australia, there are generous research and development tax incentives that can significantly offset costs.

• Cost and quality: Balancing cost with quality requires thorough market research, robust supplier vetting, and strong supplier relationships.

By focusing on these strategies, clinical trial sponsors can efficiently manage pharmaceutical costs while maintaining high standards of quality and compliance.

Speed of sourcing

Speed of sourcing is crucial in clinical trials, as late consideration of pharmaceutical supply needs can lead to significant delays and potential protocol changes.

To mitigate this risk, it is essential to have a comprehensive understanding of market dynamics and trends, including product availability and lead times. This knowledge enables informed decision-making and effective planning.

Tips

• Early planning: Early planning is critical. Proactively addressing product sourcing, GMP activities, and distribution timelines, including import/export requirements, ensures that supplies are available when needed. Implementing strategies for rapid procurement of necessary products can significantly reduce the risk of delays.

• Sourcing processes: Streamlining sourcing processes is another key factor in reducing time-to-market. By optimising each step from procurement to delivery, clinical trial sponsors can ensure that all processes are efficient and effective. This approach not only speeds up the sourcing but also enhances the overall management of the supply chain, maintaining the integrity of the trial schedule.

Guarantee of supply

Ensuring a guaranteed supply of pharmaceutical products throughout the clinical trial period is crucial to prevent interruptions and maintain the integrity of the trial. Establishing strong supplier contracts is essential for securing a consistent supply, and regular supply chain audits can help ensure that suppliers can meet demand.

Tips

• Uninterrupted supply: Securing products for the duration of the trial presents several challenges, such as balancing the open market versus direct sourcing from the Marketing Authorisation Holder (MAH). Accurate forecasting and maintaining adequate inventory are vital, given the uncertainties in patient enrolment rates, study duration, and regulatory approval deadlines.

• Market intel: Leveraging market intelligence is key to creating accurate demand forecasts. Utilising historical data, enrolment projections, and simulation models can significantly enhance forecasting accuracy. Engaging a sourcing partner with direct relationships with MAHs can also secure product supply for the trial duration, reducing risks associated with open-market sourcing.

Lead time

Effectively managing lead times is crucial to ensure pharmaceutical products are available when needed for clinical trials. Long lead times can delay trials and impact study outcomes, making it essential to streamline supply chain processes and implement efficient procurement strategies.

Tips

• Streamlining supply chain processes This can significantly reduce lead times, and involves coordinating all stages from sourcing to delivery, and implementing technology solutions for better tracking to enhance visibility and control. Developing efficient procurement strategies, such as establishing strong supplier relationships, negotiating favourable terms, and utilising fast-track procurement methods, can expedite the sourcing of necessary products.

• Advanced planning: Understanding lead times early in the process allows for better planning and decision-making. Gathering information about product availability and supplier capabilities helps anticipate potential delays and find alternative solutions. Clinical trial supply is often considered late in trial design, resulting in delays and protocol changes. Therefore, early planning for product sourcing, GMP activities, and distribution timelines, including import/export requirements, is crucial to avoid delays.

To manage lead times effectively, start planning for product sourcing and supply chain logistics well in advance of the trial’s start date. Continuously monitor lead times and adjust plans as necessary to account for any changes. Working closely with suppliers to understand their lead times and developing contingency plans can further mitigate risks and ensure timely delivery of pharmaceutical products.

Importing/Exporting

Navigating the complexities of importing and exporting pharmaceutical products can be challenging due to varying international regulations and logistics. Moving products across borders requires a thorough understanding of custom compliance for each country involved. No two countries have the same import/export requirements, which can complicate the process.

Tip

• Knowledge is power: Effective market intelligence is crucial. It involves researching and understanding the specific customs regulations and compliance standards of all countries during the feasibility phase. Engaging specialised sourcing and logistics experts can provide tailored customs clearance solutions, ensuring that all regulatory requirements are met efficiently.

Traceability

Traceability of pharmaceutical products throughout the supply chain is vital for accountability and quality assurance. Counterfeit pharmaceuticals are a global issue that can significantly impact trial data integrity and patient safety. It is essential to secure products from robust partners who guarantee traceability.

Tip

• Use a validated supply chain: Utilising a validated global supply chain, especially from Tier-1 countries such as Australia, New Zealand, Singapore, South Korea, Japan, the UK, EU, USA, and Canada, helps in maintaining high standards of traceability.

Conclusion

Sourcing comparator and standard of care pharmaceutical products for clinical trials involves navigating a complex landscape of challenges, from regulatory compliance and supply chain management to cost control and quality assurance. By understanding these challenges and implementing robust strategies, organisations can ensure the successful execution of their clinical trials.

For more insights and expert advice on clinical trial supplies and services, contact Akesa. Our team of professionals is dedicated to supporting your clinical trial needs with comprehensive and tailored solutions.

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About the author

Karen Montgomery-Douglas brings a wealth of experience in clinical trial supply chain management, sharing her knowledge to guide sponsors and contract research organisations through the intricate process of sourcing.

Image by LinkedIn Sales Solution on Unsplash.