Business Challenge

A prominent pharmaceutical company was planning a worldwide study of a compound to treat hypertension and congestive heart failure. As with any global endeavor, a number of challenges required solutions before the study was able to commence. These included:

• Because the study involved 17 countries, a wide array of unique labeling had to be implemented.
• Similarly, because the study drug was to be expiration tested at six-month intervals, labeling had to be flexible enough to facilitate unique labeling as expiration date information changed.

Constraints

• Time: The sooner the global study could be completed, the quicker the drug could be marketed and revenues could be realized.
• Quality: Management of such a large endeavor requires adherence to specific quality assurance controls.
• Regulatory Requirements: In a domestic scenario the regulatory requirements are complex and plentiful. When the study traverses 17 countries they become unwieldy.

Solution

Fisher Clinical Services assembled a team of appropriately skilled employees to identify and implement a strategic solution that would permit our client to overcome the challenges and fulfill their international testing objectives. The Fisher Clinical Services team worked in conjunction with the customer and organizations in 17 countries to develop and implement:

• A multilingual booklet label that captured all regulatory requirements for each country.
• A computerized labeling process, linked to global distribution software, which provided on-demand, country-specific labeling.

These solutions allowed the pharmaceutical company to conform to the regulatory requirements for each country, and to print labels with changing expiration date information and country-specific requirements.

Interactive Voice Response technology and Material Pooling, a method of linking the patient to the appropriate medication at the last possible moment, were implemented to monitor patient recruitment and expiration information, and to optimize the flexibility of supplies.

Additional innovations were implemented to streamline the processes, including:

• Enlisted Drug Management Supplied staff to develop custom system to meet specific customer requirements. Allowed real-time clinical supply information management, reduced drug/packaging waste, and enabled just-in-time re-supply based on actual site usage.
• Used North American and European distribution centers to maximize efficiency of clinical supply distribution. WAN implemented between North America and Europe.

Results

"Fisher Clinical Services rapidly executed dynamic solutions that enabled us to initiate and monitor a complex global study with the utmost flexibility and confidence."