This seven-year outcomes study was critical to the success of a compound that is expected to build on the sponsor’s leadership position in diabetes care. Because of the study’s importance, as well as the costs associated with this multiyear program, keeping enrollment and study timelines on track was of paramount importance to the sponsor.
This phase III global program, involving four protocols and approximately 300 sites, was critical for a sponsor striving to make its compound the leader in a potential $1B gout market by 2018.
A leading pharmaceutical company approached Fisher Clinical Services to assist them with obtaining comparator study medication for a global Phase III program. The trial was focused on an infectious disease and would involve 25 countries across 130 investigator sites.
A major global pharmaceutical Sponsor was seeking a new approach to enhance the efficiency of their supply chain process including their label and translation management approaches.
Our client, one of the top major pharmaceutical companies with research priorities aligned to significant global health needs – diabetes, heart disease, cancer and mental health - had a high number of studies already in progress in the Asia Pacific region.
Our client, one of the top major pharmaceutical companies approached us for guidance on how to run an ambitious clinical trial in the Asia Pacific region; a trial involving 10+ countries, 74+ sites with 400+ shipments across the region.
A global pharmaceutical company was developing a large molecule drug for a gastroenterology indication and wanted to set up an automated process for assembling pre-filled syringes without compromising container integrity.
In 2007 Synergy opened a Clinical Data Management Department with local, low-budget projects and decided to implement an open source EDC solution as a clinical data collection tool. This tool required installation and validation every time a new project was started. When the number of projects started to multiply, management quickly realized they had two options: expand their IT resources to support data management applications or outsource. They chose the second option so they had to find a cost-effective, pay-as-you-go, cloudbased EDC solution which would allow them to move their current EDC projects without interruption.
Mid-trial decisions to address unexpected issues—such as a product shortage—deserve to be made with all the facts. Often, those facts are hard to come by and require visibility to the entire supply chain. That was the case for one sponsor conducting a complex Phase III trial across a number of countries. Almac Clinical Technologies and Almac Clinical Services teamed up to provide a complete risk assessment and cost analysis of various solutions, making the most cost-effective choice obvious.
Managing large global trials involving tens of thousands of patients is only possible with the help of automated systems such as Almac’s IXRS. Yet, even with the use of software to randomise patients and manage kit assignments, anomalies can crop up in the way that sites deal with patients and kits.
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