Risks of Investigator-Managed Supplies
Clinical teams in pharma and biotech often look for ways to optimize budgets and streamline operations. One approach that may seem efficient is allowing investigator sites to order their own ancillary supplies for clinical trials. While it may appear to offer greater flexibility and control, this decentralized model introduces hidden risks in clinical trial supply chain management, such as including increased costs, regulatory risks, and operational inefficiencies.
- Lack of Standardization
When investigator sites source their own ancillary supplies and equipment, it creates inconsistencies in product quality, regulatory compliance, and compatibility across sites. These discrepancies compromise study integrity and patient safety, which are critical aspects of regulatory compliance in clinical trials.
- Higher Costs, Not Savings
It may seem cost-effective to shift ancillary supply management to sites, but it often leads to higher overall expenses due to:
- Paying higher per-unit costs due to non-bulk purchasing
- Missing supplier discounts compared to centralized procurement
- Adding administrative burden on sites
Rush orders alone can cost up to 50% more than standard procurement, according to industry data. By contrast, centralized procurement strategies use economies of scale and supplier negotiations to lower costs and improve financial efficiency across the clinical trial supply chain.
- Regulatory and Compliance Risks
Allowing investigator sites to independently manage ancillary supplies increases the risk of using non-compliant or unvalidated products. This can lead to protocol deviations, audit findings, and delays in regulatory approvals. Effective clinical trial risk management becomes much harder to maintain with decentralized procurement.
Recent FDA Form 483s from 2024 cited sites for poorly maintained equipment, missing calibration records, and failure to follow sponsor protocols. These issues could have been avoided with centralized quality control. Poor site-level burden management in this area can significantly delay trial timelines.
- Logistical and Supply Chain Issues
Centralized procurement streamlines clinical trial logistics, inventory tracking, and supplier accountability. When sites handle purchasing non-IMP supplies, there’s a higher likelihood of stockouts, shipment delays, and supply mismatches, impacting trial timelines and data integrity. A strategic approach to clinical trial solutions ensures that the supply chain runs smoothly, mitigating these risks.
- Improper Equipment Management
Most sites lack the resources to handle the full lifecycle of clinical trial equipment, including calibration, maintenance, and end-of-trial disposition. Without centralized oversight from a partner, trials risk delays, noncompliance, and increased costs due to improper equipment management.
- Complicated Inventory Management
Effective inventory tracking and replenishment require specialized systems and oversight that many sites lack. Poor inventory management can lead to stock shortages, expired supplies, and inefficiencies that delay trials.
- Burden on Investigator Sites
Asking sites to handle procurement adds unnecessary stress to already overburdened staff, increasing the risk of mistakes and delays. This can negatively impact site satisfaction and retention, ultimately hindering the success of your trial.
- Negative Impact on Sustainability
When sites independently order ancillary supplies, inefficient ordering, increased packaging waste, excess inventory, and redundant shipments contribute to unnecessary carbon emissions and environmental waste. Centralized procurement allows for optimized shipping, reduced packaging, and better resource allocation, supporting sustainability goals.
- Compromised Patient Safety
Improper supply management can directly affect patient safety. Issues like expired products or supply shortages can lead to adverse events or delays in treatment, impacting both patient health and trial integrity.
A Smarter Approach to Ancillary Supply Management
Instead of pushing procurement to individual sites, clinical teams should partner with a full-service provider that manages ancillary supply management from trial start-up through closeout. A global, strategic partner helps sponsors reduce site burden and deliver high-quality, cost-effective solutions for every aspect of the clinical trial supply chain.
A global partner can:
- Reduce costs through economies of scale and supplier negotiations
- Ensure regulatory compliance in clinical trials and product standardization
- Streamline logistics and inventory tracking
- Manage equipment calibration, maintenance, and reclamation
- Support sites by allowing them to focus on patient recruitment, enrollment, and care
- Advance sustainability goals through smarter supply management
Having clinical sites manage their own ancillary supplies, equipment, and medical devices does not optimize your clinical trial supply chain management. In an industry where precision, compliance, and patient safety are critical, decentralized ancillary supply management introduces unnecessary risks and headaches. A dedicated partner ensures streamlined operations, regulatory compliance, and cost efficiency.
Ready to simplify your clinical supply chain and protect your clinical trial’s success? Let’s talk.
References
- Counting the Ways Supply Chain Inefficiencies Impact Patient Care, Medical Design & Outsourcing. Read
- FDA Form 483 Observations, 2024. U.S. Food and Drug Administration. FDA.gov
