Clinical Trials: Clinical Trial Operations & Compliance

Direct-to-Patient (DTP) Logistics in Clinical Trials

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Direct-to-Patient (DTP) logistics—delivering investigational medicinal products (IMPs) directly to patients’ homes—has emerged as a cornerstone of decentralized clinical trials (DCTs). For US sponsors, the FDA has increasingly focused on DTP oversight due to risks in chain of custody, temperature control, and accountability. While DTP models improve patient convenience and recruitment, they also introduce compliance challenges, requiring meticulous planning, vendor oversight, and regulatory alignment.

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Clinical Trial Logistics, Clinical Trial Operations & Compliance

Returns and Destruction of Investigational Products in Clinical Trial Logistics

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The management of investigational medicinal product (IMP) returns and destruction is a critical component of clinical trial logistics. Improper handling of unused, expired, or damaged IMPs can result in data integrity issues, regulatory non-compliance, and patient safety risks. For US sponsors, FDA requires documented accountability of IMPs throughout their lifecycle, including return to depots and destruction under controlled conditions. Failures in this area often result in FDA Form 483 observations or warning letters.

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Clinical Trial Logistics, Clinical Trial Operations & Compliance

Risk Management in Clinical Trial Supply Chains

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Clinical trial supply chains are inherently complex, spanning global depots, couriers, customs authorities, and investigator sites. Risks such as temperature excursions, customs delays, comparator shortages, and logistics vendor failures can directly affect patient safety and trial integrity. For US sponsors, the FDA requires that risks to investigational medicinal products (IMPs) are identified, mitigated, and documented as part of quality management systems (QMS). Failure to manage these risks can result in Form 483s, warning letters, and trial delays.

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Clinical Trial Logistics, Clinical Trial Operations & Compliance

Sustainability in Clinical Trial Logistics

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Clinical trial logistics traditionally focuses on compliance, safety, and supply continuity. Increasingly, regulators and stakeholders are emphasizing sustainability in the supply chain, requiring sponsors to minimize environmental impact without compromising compliance. US sponsors face scrutiny from FDA on proper waste disposal, packaging, and destruction processes, while EMA and WHO promote green initiatives across the supply chain. Incorporating sustainability aligns with global corporate responsibility goals and strengthens sponsor reputation in addition to regulatory compliance.

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Clinical Trial Logistics, Clinical Trial Operations & Compliance