There are a number of reasons why sponsors seek to outsource their clinical supply operations. Cutting costs, reducing waste and a reduced cycle time are some of the main motivations behind outsourcing activities. However, successfully coordinating the logistics of shipping investigational material products (IMP) to clinical sites remains one of the most significant challenges in clinical supply management.
It goes without saying, therefore, that choosing the right vendor is essential. So what are the key essentials to a successful supply chain strategy? Below are four tips:
1) Identifying and Selecting the Right Vendor
First things first, it’s vital to understand any prospective partner’s competence, dedication, know-how, and dependability as this will help whittle down the list of potentials. Learn if the vendor has sufficient and proven experience in change management. What’s more, it’s beneficial to engage the QA at the earliest stage possible in order to determine a CMO that will carry out unit operations from cradle to grave. Other key considerations include:
- Carry out financial and compliance assessments
- Gauge their technical capability
- Perform assessments analyzing their project management strengths and weaknesses
- Analyze their levels of experience, turnover of staff, their capacity, etc.
2) Engaging your chosen Vendor
Once a suitable vendor has been selected, the sponsor should develop a robust contract that is favorable and in keeping with the company’s business strategy. Demonstrate full commitment by implementing the Master Service Agreement (MSA). Ensure the MSA factors in intellectual property, discovery protection, confidentiality, liability, and insurance.
On the other hand, the Statement of Work (SOW) must clarify project deliverables, activities conducted, as well as business requirements. If discounts for the volume of work conducted in a fiscal year are to be included, ensure they are well-documented and acknowledged.
Make sure the requirements as stated in the SOW are clear and understood by way of a formal request process. The SOW must have in place clear terms and conditions that are specific, feasible and timely.
3) Documenting and Maintaining Oversight
Oversight of your vendor(s) is a process that’s critical throughout the life span of a trial. Successful vendor management depends a lot on the governance structure you implement. For a start, at the beginning of a partnership, it’s incumbent upon the sponsor to establish milestones – key points during the study where a target has been reached. Therefore, it is advised sponsors put in place regular project meetings, as well as business review meetings (biannually) with vendors to ensure everything is on track, and crucially, to raise issues that need to be resolved.
With that in mind, develop an escalation plan for all parties involved, including the CRO and CMO. If ever there’s an issue in the delivery of supplies to a site, the vendor will need a point of contact within the sponsor company, and a plan of action needs to be prepared. If there are issues concerning the payment of invoices, it’s needs to be escalated through the proper channels.
4) Lessons Learned
Throughout the course of the study, it’s always important to have a handle on what’s working and what isn’t. What lessons can be learned that can be applied when working with other vendors on other projects? Here are two things to consider:
When it comes to inventory management, more often than not, money goes down the drain when storing supplies (e.g. IMP, ancillary items, etc.) that have expired, or are no longer needed. Oftentimes, when an IMP is stored in the cold chain, the storage fee is doubled. Therefore, manage your inventory on a regular basis and ensure used or expired IMPs are disposed of in a timely manner.
When putting together the SOW, it’s important to be accurate when estimating, for instance, packaging and labeling (P&L) campaigns. If there’s an amendment that needs to be made, bear in mind a legal review will be carried out. If it’s the case that you will need three P&L campaigns, make that clear to the vendor, and know what you need upfront as ultimately that will save the sponsor in time and money.
*Adapted from James Krupa’s ‘Vendor Management in the Clinical Supply Chain’