A Brief Overview of Ancillare Accomplishments
Ancillare’s unique specialized CRO services provide us with a variety of accomplishments in varied applications with our customers. Here is a small collection of Ancillare case studies intended to showcase our model and highlight its success in the market.
- Supplier and Compliance management
- APT in Action: Managing suppliers and regulatory requirements globally
- Read about APT in Action >>
- Global Logistics Management
- APT in Action: Managing special supply programs and global shipping
- Read about APT Management >>
- Supply Chain Innovation
- APT in Action: A product solution to an investigator site bottleneck
- Read about APT Innovation >>
- Partnering with Investigator Sites
- APT in Action: Product training and installation with investigator sites
- Read about APT Field Presence >>
Efficient Clinical Trial Management with Ancillare
The Situation: : An Ancillare customer managed all protocols internally and administered trial supplies across multiple departments and individuals. The resulting system contained redundant suppliers, inefficient shipping programs, weak buying power, and tenuous supplier compliance.
Products were improperly shipped from suppliers, standardized supplies were difficult to manage, customer service was non-existent, documentation was incorrect for international shipment, and countless resources were wasted.
The decentralized supply systems were increasing the time and cost of the protocols and were placing the company at great risk of a delayed or cancelled trial program.
The Ancillare Solution: Ancillare constructed a pilot program for the customer that deployed our unique APT approach by therapeutic area. Leveraging our clinical trial process expertise, Ancillare was quickly able to create specialized buying, shipping, stocking, inspection, compliance, and management programs to build efficiency into the system.
Our APTs worked within the customer’s supplier network to evaluate participants and build a dedicated supply network. We leveraged our buying power to obtain better price points, tracked shipments, and managed customer service. Lastly, we were even able to reduce the number of invoices generated in the system to build the most efficient clinical trial management system possible.
The Result: : Ancillare reduced the supplier network from hundreds of diverse suppliers to a handful of dedicated partners. We built an efficient shipment system that effectively eliminated delays in the supply chain. Our APT handled all documentation gathering and global compliance to ensure efficient progression of the protocols. Our lasting relationship created double digit cost savings while allowing our customer to shift focus from problem containment to strategic trial planning, building efficiency and accountability on a global level.
Supply Chain Innovation for Success
The Situation Ancillare received a request from a customer and its investigator sites to find a solution to a bottleneck in the administration of clinical trials using infusion bags. As the protocol called for blind study administration to patients, investigator sites were consistently frustrated by loss of data and trial time due to improperly blinded tests.
Because of this growing problem, the customer frantically attempted to train investigator sites for a solution but fell short due to a lack of standardization. The APT for the relevant therapeutic area began to search for alternatives to the current system and found that there was a lack of innovation in this supply chain.
The Solution: : The Ancillare APT exhausted the supplier network in the area and found that no current product was suitable for the requested application. The Ancillare management team responded quickly and coordinated with supply partners to evaluate a solution.
Our industry expertise allowed us to develop a novel product for the situation and deliver it to the customer to meet their specifications. After the prototype was approved, Ancillare managed the supply of over 100000 Ancillare Infusion Bag Covers (patent pending) to the investigator sites and trained them accordingly for the product’s use.
The Result: : The investigator site bottleneck was removed, test administration was guaranteed blind, and trial time was dramatically reduced. The program was so successful that 4 different variations of the product were created, allowing for additional solutions to unrelated problems for the customer.
Investigator Site Trial Support
The Situation: : One of our customers required a specialty filter to be used for the infusion of an oncology product being tested in the field. The Ancillare APT conducted its research, called upon its medical advisors and identified a product that met all the clinical specifications. The product was approved by our customer for use in the field. After three months of use in the field, our customer notified the APT that a site in the EU was experiencing leakage issues.
The Solution: The APT coordinated with the customer to design a field survey to be distributed to all sites. The APT discovered that there were no other sites throughout the world that experienced the leakage issue. At the same time, the APT contacted the factory to report the quality issue. The product was received by the APT and returned to the factory for QA inspection process. New product was shipped to the EU site at no charge so that the study would not experience interruption.
Infusion by field personnel resulted in continued leakage and the factory determined that the product was not defective. The field personnel were not using the filters properly and the APT worked with the factory to produce a new manual to promote proper usage of the product during trials. The APT translated the manual into several languages and worked with sites to train for proper usage of the product.
The Result: The APT was able to work directly with the investigator sites and the factory to obtain a solution to the problem without any delay in the progression of the trial. The APT worked with the individual sites to train for proper usage of the product and removed any chance of administration errors in the future. The factory now includes the manual with all new sales of the product and no further leakage reports have been reported.
Promoting Global Accountability
The Situation:An Ancillare customer was reporting excessive rogue spending by investigator sites marked by repeat reorder requests for product and frequent purchase of products without prior approval. Clinical trial product spending was excessive and the lack of product standardization lead to questions about the validity of the trial claims from the investigator sites. With no way of tracking actual site usage, there was no guarantee that trials were performed according to protocol specifications.
The Solution: Our APTs deployed an approved version of the Ancillare Research and Development Management System creating approved product storefronts, buying limits, stocking programs, demand analysis and patient distribution scheduling, order tracking, and product administration analysis. The system effectively monitored all site usage patterns and automatically updated stocking programs based on additions to the patient database. The APT and ARDMS did not require additional involvement by the customer and managed the process through one source with full documentation to satisfy all protocol requirements.
The Result: The APT and ARDMS allowed for full process accountability by monitoring site level activity and recording events throughout the progression of the protocol to ensure that all guidelines were followed exactly. As a result of the unique solution, the customer obtained double digit savings while gaining oversight over trial activities at no additional personnel cost. All rogue spend was eliminated and full protocol standardization was achieved by using our model.
