Comparator Sourcing for Clinical Trials

Clinical trials form the foundation for the development of new drugs and treatments and require meticulous planning, execution, and reliable data. Within this framework comparator sourcing forms a critical aspect for the design of clinical trials to enable confident testing of the safety and efficacy of new drugs. However, finding the required comparators can be challenging as companies need to ensure reliable access to comparator drugs and proficiently navigate a range of operational, regulatory and logistics procedures and, in parallel, overcome any financial obstacles.

Comparator Sourcing Challenges

Navigating the complexities of comparator sourcing can seem daunting with several factors contributing to the complexity of this process. These include:

• Availability: Acquiring a sufficient and uninterrupted supply of comparators can be challenging. Pharmaceutical manufacturers often place limitations on the acquisition of their products for use as comparators and high demand for certain drugs can lead to supply issues on the open market in addition to lengthy approval processes. Companies need to be aware of the volume of supplies available from manufacturers and how this may change over the duration of the trial.
• Meeting Regulatory Compliance: Meeting regulatory requirements is crucial in clinical trials. Sourcing specialist partners who can provide custom clearance solutions and adhere to regulatory standards, such as Good Manufacturing Practice (GMP) guidelines, is essential to ensure the credibility and acceptance of trial results by regulatory authorities. Different legislation across countries, in addition to language barriers, can make the process complex and quite often, impractical to manage.
• Logistics: Comparator sourcing for clinical trials can pose logistic challenges. It is vital to ensure the timely and secure transport of comparators from suppliers to trial sites. This can involve coordination across multiple stakeholders to ensure seamless delivery while adhering to strict regulatory requirements. Moreover, maintaining temperature-controlled storage solutions throughout the transportation process is crucial to preserve the integrity and efficacy of products. Additionally, efficient stock management practices are essential to prevent shortages or overstocking, as comparators need to be available in the right quantities at the right time. Proper labelling and packaging can also form a requirement as they must comply with local regulations and be easily identifiable at the trial sites.
• Cost: Undoubtedly cost is a key factor influenced by volume requirements, import/export fees, logistics, and price variations across regions can dictate the financial feasibility of a study. Striking a balance between quality and cost-effectiveness is a constant challenge for researchers.

Oximio Comparator Sourcing Solutions for Clinical Trials

Comparator sourcing is a crucial component of clinical trials. The challenges faced in this process necessitate careful planning, collaboration, and innovative solutions. A reliable and experienced partner who can meet regulatory demands, deliver quality compliance and meet logistic requirements is essential to overcome comparator challenges. With dedicated project managers providing tailored solutions to meet budgets and timelines, here’s how Oximio can help:

• Comparator drug sourcing: Thanks to our geographical footprint, Oximio has both capabilities and capacity for central and local drug sourcing across Europe, USA, Africa, Middle East and Asia. This extensive reach enables complete objective analysis of availability in addition to very competitive pricing. In addition, we can obtain the appropriate expiry, batch requirements and shortest lead time. Oncology remains one of the most predominant therapeutic areas of clinical research and Oximio benefits from direct access to invaluable compactor medicines. These are importantly backed with all the relevant regulatory documentation. Oximio is able to provide the best market solution, together with global shipping and excellent lead time in addition to a variety of dose formulations and quantities.
• Regulatory compliance: Navigating regulatory requirements from country to country is not without its challenges. With a proven track record with internationally recognised standards for disease treatment and prevention, Oximio works within clear regulatory requirements including Good Clinical Practice (GCP) and Good Distribution Practice (GDP). We will endeavour to obtain the necessary documentation that is requested to support clinical trials from a regulatory perspective.Our highly qualified medical investigators provide high quality data inspected and approved by the European Medicines Agency (EMA) and US Food and Drug Administration (FDA).Via our Importer of Records capabilities and in-house local regulatory experts, we provide specialized custom brokerage services with in-depth regulatory review at the early stages of clinical supply chain planning.All Oximio sites have WDA licences.Customs bonded warehouses in Kenya, Georgia and Serbia provide not only customs privileges but cost benefits.
• Logistics solutions: Due to Oximio’s extensive network of depots in different countries, this gives us the ability to be flexible and provide the most effective and appropriate logistic solution. For international shipments, we can act as Export of Record (EOR) and manage Importer of Record (IOR) in some instances.

• Storage & Distribution: Via our network of depots and customs bonded warehouses, we are able to offer distribution and storage facilities. Protecting the safety of samples is paramount. Temperature control solutions are available across Oximio depots and warehouses, supporting a range of temperature requirements from ambient, refrigerated and frozen to dry ice:Ambient (15⁰C to 30⁰C)
  Refrigerated (2⁰C to 8⁰C)
  Freezer (-25⁰C to -10⁰C)
  Ultra-low Freezer (-90⁰C to -70⁰C)
• Labelling and packing: Relabelling is often a requirement in clinical trial logistics as labels for investigational medicinal product (IMP) may need to be adapted to meet the specific regulatory requirements within the country that the trial is being held. Oximio can provide both labelling and packing solutions at the majority of its warehouses.

For information on our comparator drug sourcing and ancillary supplies, please visit our website or simply contact us. With dedicated project managers, we would be delighted to help