Pharmacovigilance (PV) is a critical aspect of drug safety, focusing on detecting, assessing, understanding, and preventing adverse drug reactions or other drug-related problems. As global regulatory requirements for drug safety evolve, adopting reliable pharmacovigilance software has become essential for ensuring compliance and improving operational efficiency. Selecting the right PV software can significantly impact your organization’s […]
Calian expects Flex Databases to streamline their clinical trials by centralizing data, reducing manual work, and improving overall efficiency. This will lead to faster trials and better-quality information. The implementation of Flex Databases will improve Calian’s oversight capabilities and provide a single source of truth for their studies. This forward-looking approach ensures their ability to efficiently scale up and consistently provide the best service to their customers.
We’ve asked Calian’s team several questions about our partnership.
What were the key factors for Calian to choose Flex Databases over other eClinical providers?
Cheryl Marron: The key factors that led Calian to choose Flex Databases over other eClinical providers were the combination of functionality and customer service. The team’s availability to answer questions and support multiple demonstrations also played an important role in our decision-making process.
How does Calian anticipate Flex Databases’ system will impact the management and efficiency of their clinical trials?
CM: The implementation of Flex Databases will improve our oversight capabilities and provide a single source of truth for our studies. This forward-looking approach ensures that we maintain a consistent process across all studies. By utilizing the CRA Activities Management module, we can automate processes such as monitoring visit report writing, ensuring timely and accurate reporting. This system will drive efficiency in reporting, improve data consistency and streamline tracking for improved speed and quality of project oversight. Additionally, it will enable us to catalogue the types of projects we’ve worked on, providing valuable metrics to highlight our extensive experience across various therapeutic areas and geographies.
Is there any feature in Flex Databases’ CTMS, PV, and Project Management & Budgeting system that Calian found particularly compelling?
CM: We found the CRA Activities Management and the Project Management modules particularly compelling. We look forward to developing a robust process for the setup and oversight of our projects, effectively managing our growing team of resources, and having a single source of truth for project status, timelines and milestones. While we often work with companies that manage their own PV databases, this tool will enable Calian to expand our service offerings to smaller companies that require this support.
What are challenges that Calian was facing that led them to seek out a CTMS, PV, and Project Management & Budgeting solution? How does Flex Databases’ solution address these challenges?
CM: At Calian, we are always looking for ways to innovate and find efficiencies in our processes. We see an opportunity to streamline information from multiple systems into one centralized location, making it easier to create reports and track KPIs across the CRO portfolio. This will give senior management a clear view of each project or product in one place. We believe Flex Databases can help us achieve this by centralizing information and maintaining consistent and accurate reporting, therefore improving our project oversight and decision-making process.
What are Calian’s expectations regarding the support and service from Flex Databases during the implementation phase and beyond?
Our expectation is that Flex Databases will provide comprehensive support, including training and responsive assistance as we rollout our studies. During the implementation phase, Calian anticipates receiving suggested approaches, considerations, and warnings for potential pitfalls to ensure a smooth rollout. Our goal is to be well-equipped for success and sufficiently trained to operate quite independently within the system.
Calian seeks a collaborative partner that will grow alongside us and our clients. As our needs evolve, we expect Flex Databases to incorporate our feedback for continuous improvement, allowing us to remain competitive and benefit from ongoing tools and efficiencies. We value a partnership where our feedback is appreciated, understanding that system improvements made for us can also benefit other clients and open potential for referrals, which can drive new business and further strengthen our collaboration. Lastly, we anticipate fair price adjustments over time, reflecting responsible corporate management and ensuring a lasting partnership.