Modern protocols require a global scope to produce products to market in various countries. This often means that clinical leaders and sponsor organizations must manage the global system from a remote location, relying on robust plans and strong investigator sites. However, as the process unfolds sponsors often find challenges in implementing the global requirements. Accountability and decentralization create strains that make standardization and accuracy difficult to achieve. At Ancillare, our experienced team of experts understands the clinical process and the challenges that global clinical leaders face in achieving success. Our model helps promote protocol success by focusing on four key areas throughout the duration of the trial:
1. End-to-end process management
A strategic partner that manages the process from pre-first patient in to post-last patient out is essential to ensure the success of a protocol. By working directly with sponsor organizations and investigator sites, Ancillare is able to manage the flow of materials and information throughout the trial to ensure that timelines are met, bottlenecks are eliminated and efficiency is maximized at the global level.
2. Global Logistics:
Successful protocols require management of materials and service providers throughout the clinical trial. As a partner, Ancillare manages logistics, from kitting and storage to import and return of supplies worldwide. Our expertise allows protocols to progress smoothly, reducing costs and trial time throughout the duration of the process.
3. Regulatory Compliance:
Failure to adhere to local regulations results in high costs, increased trial time and accuracy issues in any global protocol. Ancillare works with sponsor organizations and investigator site locations to ensure that regulatory compliance is achieved and eliminates pressures throughout the process.
4. Lean Methodology:
Protocol management requires careful attention to detail. At Ancillare, we believe that the burden should not fall on sponsor organizations to provide specialized experts for each protocol. Instead, we offer the industry unique Ancillare Professional Team to implement the flexible staff augmentation necessary to achieve therapeutic area expertise for even the most complicated protocol design.
Ancillare understands the global clinical trial process and provides the expertise, processes and proven experience to achieve excellence in modern protocols. Our services help sponsor organizations reduce costs, increase efficiency and promote accuracy and accountability at a global level. Through our dynamic partnership, Ancillare helps ensure protocol success no matter the size or complexity of the project.
