In today’s highly competitive market for new drug development, sponsors are challenged with balancing cost, time and quality to deliver the best possible outcome for their trial, and more importantly for their patients.
Cost overruns can be critical – especially for emerging companies who are tasked with raising funds to cover development costs. For large pharma, where an outsourcing strategy allows them to focus on core strengths, managing their budget is equally important.
Timing is everything. Accelerating the product approval process translates to a faster income stream that offsets the sponsor’s development investment. As trials evolve and progress through phases, change is inevitable. Clinical trial packaging is often impacted by changes to the protocol such as dosage changes, increases or decreases in volumes, changes to expiry dates, inclusion/exclusion of countries that weren’t part of the original plan. Accurately identifying and predicting issues that might impact schedules, while remaining nimble to adjust to changes is imperative.
Most importantly, quality can never be sacrificed. It’s important to recognize that quality has a cost and time impact on the study. Through diligent upfront planning we integrate quality assurance into every facet of the packaging design plan, proactively anticipating risks and identifying an action plan that mitigates that risk.
The Fisher Clinical Services team leverages 27+ years of clinical trial packaging design experience when working with study sponsors. We understand the importance of taking the time required to establish a detailed understanding of your needs. Throughout the thoughtful collaboration process, we serve as a trusted advisor to help you strike the best balance of cost, time and quality.