Imagine a scenario where your clinical trial team orders a reference-listed drug with an approved shelf life of 24 to 36 months. However, when it reaches a clinical trial site, you have an RLD with less than 12 months to use.
Case in Point
Pertaining to a recent case involving an immuno-oncology blockbuster. Despite its approved 24-month shelf life, the US reference product was only available with 12 months remaining, even when directly sourced from an originator.
For companies developing generics, the short shelf lives of Reference Listed Drugs (RLDs) can disrupt timelines, drain resources, and pose hurdles in the drug development process.
This can be a daunting situation, as it puts many things at stake. This can lead to halting the study, patients not receiving assigned study medication, study delays, hinder future research, and result in financial loss for the clinical trial sponsor including product registration delays.
Understanding the critical nature of this problem, Spring Bio Solution came up with a solution, leveraging its 14+ years of market intelligence.
360πππ¨π©πβ’- Solution to the Problem
Spring Bio Solution offers a 360πππ¨π©πβ’ client approach for solving pressing issues like these. This approach is designed to address the challenges faced by clients in sourcing RLDs through strategic planning.
360Scopeβ’ Client Approach is an all-in-one solution that begins with a deep, comprehensive situational analysis. This ensures that we understand every detail of your study. We go beyond standard sourcing by aligning your protocol requirements with real-world market dynamics, offering a seamless comparator procurement experience. Our proactive risk-minimization strategies are designed to keep your trials moving forward.
Are you curious how 360πππ¨π©πβ’ ensures every drug we source has the shelf life that matches your trial needs?
If so, itβs the right time to contact us to learn how we can assist you with cost-effective and compliant RLD sourcing that meets suitable expiration dates.
