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Below is a recent example of where our therapeutic expertise has helped deliver results.
Trial delivery: Kendle gets it right again
In addition to being a recognized leader in biometrics for vaccines research, we’re also known for the quality of our clinical monitoring and patient recruitment work in this area. So when a global pharmaceutical company wanted to conduct a large vaccine trial in nine Latin American countries, they came to us. The trial involved monitoring 50,500 patients at 94 sites. It was a huge undertaking, but Kendle Latin America handled it with expertise.
When our contract was due for termination, the customer was so impressed with our monitoring services and patient recruitment results that they extended the time of our involvement in the trial for another five months. A great result for us, and the customer too.
A large adjunctive oncology study
We delivered the largest trial ever conducted of adjunctive therapies for the treatment of oncology patients with severe chemotherapy-induced nausea and vomiting. The trial, for a privately-owned European Healthcare Company, comprised five multinational full service Phase III studies. It aimed to recruit over 2800 patients at 360 sites worldwide, but it was a complex undertaking and site recruitment was initially slow.
After identifying this we took the project management to a more senior level and introduced a project director, to ensure all expectations were met, or even exceeded. We used our experience to speed site and patient recruitment by adding countries and regions rich in qualified investigative sites and patient populations who met the study criteria, for example Mexico and Russia.
Kendle Regulatory Affairs provided support in the assembly and filing of the NDA in the US, and the NCE was approved by the FDA in 2003. The product gained approval in 297 days, the fastest out of 12 products undergoing a standard review procedure in 2003, a true measure of our ability to turn around a slow study start-up.
Partners in practice
When a pharmaceutical company came to Kendle with a request to run an entire program in the therapeutic area of inflammation, we set up a team to provide the full range of clinical development services. With more than 14,000 patients in North America and Europe, the main problem was how to achieve speed, while maintaining the highest level of quality.
Weekly team meetings allowed for continuous planning and updates to the project plan, providing each team member with a solid understanding of the milestones to be accomplished and the aggressive timeline associated with each.
This project management structure ensured rapid study execution. In one especially critical study, 96 of 120 sites received IRB approval in only 14 days. Site contracts were finalized within the same 14 days, with some being completed in as little as three days. As for data management, CRFs for the entire program were, on average, scanned and indexed within 24 hours of receipt; databases were updated within 48 hours of query return; and the fastest database locks from date of last patient observation were a record-breaking 8, 10 and 12 days  |
