Multipharma, a global leader in clinical trial supply sourcing, discusses the problems connected with clinical trial supply procurement and how they can be conquered.
Major factors impact clinical trial supply procurement, including market availability, supply requirements and specifications, and the international geographical spread of trials in general, but the associated sourcing and project management of clinical trial supplies should not be underrated. Clinical trial supplies, specifically comparative agents as either investigational medicinal products or as non-investigational medicinal products, are a unique commodity. Outside of the supplies not always being available due to market demand, the specifications to be fulfilled throughout the procurement process can further limit the availability of the products.
Since the geographical spread of trials has forced teams to become knowledgeable in unfamiliar regional territory, increasing information intelligence on the desired regional infiltration and appreciating the 'lay of the land' have an impactful consequence on this procurement process. Pharmaceutical market authorisation variation, logistical barriers, quantity fulfilment concerns, multiple languages, various time zones and other cultural aspects are some of the considerations that are vetted during the sourcing strategy process. This thought activity influences the intentional decision of whether to source locally or centrally.
Availability seems to be the most prevalent sourcing obstacle to overcome. Availability limitations apply to the supportive compliance paperwork needed to assure the quality of that material as well as information intelligence on the product profile. Market availability and manufacturing discretion can limit the supply due to the obvious competitive reasons. In addition, because most companies are comparing their product to the best-in-class drug on the market, the most popular pharmaceutical is in high demand, and this can result in long lead times.
Although sourcing is such a small part of the overall clinical trial supply chain, it can often be the most challenging due to the high-quality specifications. Adequate due diligence in regards to the fulfilment of these needs has often impacted trial timelines negatively; however, this can be mitigated depending on the clinical trial specifics and the flexibility of requirements.
The goal of sourcing clinical trial supplies is simple: to ensure that authentic material can be secured. Therefore it goes without saying that having a reliable, direct, safe and efficient supply chain is essential to the overall success of a clinical trial.
In all cases, the procurement, storage, inventory management and distribution of these supplies must be held to the highest regulatory standards. All too often, steps that can be implemented to ensure the integrity of the supply chain are easily overlooked, and many organisations are forced to waste time, money and energy in re-work, rather than taking advantage of these checks and balances.
The clinical trial environment is very labour-intensive, time-sensitive and ever-changing. As a general rule of thumb, complementary partnerships can assist in areas where there are limited or no in-house capabilities.
Determining the complexity of sourcing supplies for the trial is arguably the biggest initial stumbling block. Procurement should be an integrated process within the overall clinical trial strategic plan and it is worth considering the following steps.
During this phase, documenting what, how, when, from whom and from where the supply will be sourced, as well as evaluating the warehousing, distribution and inventory reconciliation requirements are two of the most important outcomes. Sourcing can be done internally, outsourced or a combination of the two. Many teams opt to source internally through either on-site resources or through their trial sites, while others choose to outsource procurement to specialised providers. With the objective being to determine the safest, most efficient and most economical option for supplying clinical trial supplies, only the sponsoring organisation can determine which avenue would be most strategic.
Whether sourcing internally or outsourcing, clinical trial supplies are secured through either the likes of the innovator company, an authorised wholesaler/distributor, or a specialty pharmacy.
When deciding on who is going to source the clinical trial supplies, determine in-house capabilities and evaluate core business functions. Inquire about accessibility to information and consider how the project and time management of the clinical trial supplies sourcing will impact the overall clinical trial timeline. Confirm their international presence and geographical reach and request a review of available case-study examples.
The expertise is out there, but sponsors have to do the research and find the organisation that best matches the needs of the clinical trial. Due to the global range of clinical trials, a team might find that they will benefit from a provider with the largest presence in both prevalent and emerging markets where trials are being executed. A sourcing specialist:
As when partnering with any provider, constant communication is key. The more access to internal information the sourcing specialist has, the more detailed and accurate the deliverables will be. When the sourcing provider is fully integrated with the team, the return on investment can be rewarding. Thus, confidentiality agreements and service level agreements are normally entered into when partnerships are formed.
Sponsor organisations and partners are equally responsible for the success of the trial by ensuring the quality of the clinical trial supplies. All parties involved are being held to the same good manufacturing procedures, standards and regulatory policies to guarantee no compromising of the supply chain. As a matter of fact, everyone who touches clinical trial supplies has some part in assuring that the material has been handled in the most compliant manner in accordance with all regulations.
When assessing the quality of the clinical trial supplies, ensure the use of established and reliable distributors. Confirm that there will be transparent and reliable distribution to clinical trial sites with the proper pedigree documentation. Assessments of partners should occur periodically as teams deem necessary. Just as received materials are audited and inspected for quality release, auditing partners for quality execution of requirements is also an expected task. Strive to have a consistent and thorough system in place that includes an evaluation of comparable assessment criteria.
Other recommendations to consider when partnering with a provider include:
Ensuring that clinical trials are effectively executed with sound delivery of the supply and its associated requirements is the objective. Thus, after completing the need assessment, be sure that authentic material can be obtained, and use a secure, direct, safe and efficient supply chain; then a team can be confident that the clinical trial supply chain from receipt to reconciliation can be supported. In a nutshell, each clinical trial should have its own distribution network that has been tried and tested for the proper delivery of the clinical supplies including various import/export clearance points without incident. Therefore, when evaluating the supply chain of clinical trial supplies, make it a requirement that reliable procurement policies, processes, and procedures are in place and are being performed accordingly.