In Clinical-Research Technology

PharmaNet offers a complete suite of web-based, web-accessible tools that facilitate the collection, management, and reporting of clinical trial information. Our PharmaSoft® tools incorporate the real-world expertise of PharmaNet professionals in clinical research, data management, project management, information technology, and software development. PharmaSoft tools have proven effective for more than seven years on clinical trials of all scales and complexity.

Case Study 1: Complex Global Site Distribution
Client: A large, Phase III program conducted in 13 countries, which included 5 separate protocols and 2 study extensions. Each protocol included multiple treatment arms with complex subject visit schedules. The program demanded efficient management of the study drug at sites and multiple depots
   
Challenge:

Drug needed timely, optimal distribution to the sites and depots and in accurate quantities to be available prior to subject visits.

   
Solutions:

PharmaNet IVRS was utilized to randomize subjects to treatment using multiple stratification factors and site-specific supply allocation, and to closely manage the ordering of drug from primary and sub depots. Multiple supply strategies, including target/threshold for depot-to-depot drug ordering and inventory projection for depot-to-site ordering, were set up in the IVRS to maintain accurate drug levels at study sites. Other strategies utilized for supply conservation were exclusion of discontinued subjects from inventory projection calculations, loading of drug files multiple times throughout program duration, updates to drug expiration dates, and management of site-to-depot returns of unused drug.

   
Outcome: Distribution of supplies by PharmaNet IVRS enabled optimal usage of drug, resulting in successful program completion.
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