CUSTOMER BACKGROUND

Headquartered in the United Kingdom, this CRO is a privately held, international full-service contract research organization to the pharmaceutical and biotech industry. It has grown rapidly since it was founded in 1997 and now serves its clients from its main operational hubs in France, Germany, USA, Italy and Australia, along with supporting networks of regionally based CRAs (Clinical Research Associates) in Western and Eastern Europe as well as North America and Australia. While the CRO has an established international presence, it continues to perform clinical trials and undertake various research projects with the focus of a niche CRO. Approximately 50% of their experience is in oncology, but it also provides specialist experience in rare and orphan indications, intensive care, organ transplant, cystic fibrosis and many other different therapeutic areas. A key component of their growing success is having their CRAs based either regionally or in one of their offices, working as a seamless extension of each client’s project team. This approach enables them to appropriately monitor studies in more than 30 countries worldwide in a flexible and cost-effective manner. The CRO encourages its CRAs to act as local Project Managers in proactively managing their investigative sites.

“The collaborative relationship we have with ArisGlobal continues to be strong, and our joint plans for further enhancements reinforce our decision to choose them as our clinical technology partner.”- said the customer.

LIFE BEFORE CHOOSING A SOLUTION

The CRO used several third party EDC solutions that lacked the cohesiveness and flexibility they desired. These solutions did not provide the capabilities and flexibility needed by their international offices and growing client base. “While the EDC solutions we had been using were considered market leading, we decided to take a fresh look at what other EDC offerings were available to be sure we weren’t overlooking one that would better satisfy our growing needs,” said the customer. “Our goal was to forge a collaborative relationship with the EDC vendor we ultimately selected, one that would listen to and value our input in further shaping the solution.” The chosen solution needed to be readily available, providing them with 100% regulatory compliance. Another important requirement was proven EDC-PV-CTMS integration. Better yet would be having a completely integrated solution from a single vendor, one that would automatically transmit relevant data from the EDC system to their clinical trial management system (CTMS) to trigger activities such as investigator payments and monitoring visits. The CRO was keenly aware of the benefits and advantages of using EDC over traditional paper studies and their goal was to move the majority of studies to electronic data capture. However, they still had a few paper based studies ongoing. It was therefore important to adopt an EDC solution that could easily support paper, electronic and hybrid studies. This would prevent them from having to increase resource requirements needed for database lock, which would result in costly time delays and higher integration costs. Also on the list of key criteria was the desire to reduce the time spent on managing different solution vendors. Their preference was to find a partner who could work with them for all their software solution needs. “Working with multiple vendors with differing infrastructure and support requires significant vendor management resources, especially when integration needed. As we looked to the future of having integration between EDC and CTMS, we recognized that having multiple solutions from a single vendor would be very advantageous” said the customer. Given that study teams across the global organization would use the selected system, ease of use, quality training and 24x7x365 support were other important considerations factored into their final decision.

COMPANY GOALS AND CRITERIA FOR CHOOSING A SOLUTION

A project team from Business Services, Clinical Operations, Data Management and Database Programming was formed to begin the vendor evaluation process. While the CRO gave current EDC providers an opportunity to present why they should become the chosen partner, the selection team also opened up the process to other vendors. The CRO, which had already licensed their CTMS from ArisGlobal, decided to take a closer look at their EDC solution, agCapture™. After completing their initial evaluation, a short list of vendors, including ArisGlobal, was determined and an intensive review period followed, lasting for several months. “The more we met and talked with ArisGlobal, it became clear to us they were the partner who could best meet our current and future needs,” said the customer. “We were already using ArisGlobal’s agClinical™ as our CTMS, and they demonstrated how the complete and adaptive functionality of agCapture was the right choice for us, especially as the two systems could easily integrate with one another.” The CRO chose to implement both systems on premise rather than on agOnDemand, ArisGlobal’s hosted platform. As a cost-conscious organization, they were also pleased that ArisGlobal embraced the long-term partnership view they desired and worked with them to negotiate favorable license agreement, coming in at comparatively lower terms than the other vendors they had short listed. The CRO was committed to creating a work environment that enables their employees to excel. They were a willing development partner with ArisGlobal. Both agClinical and agCapture were devised in close collaboration with ArisGlobal and the CRO’s team of data managers, data coordinators and data entry staff. These systems have been rebranded for their use. “In large part, both agClinical and agCapture are the robust and comprehensive solutions they are today because of the wonderful, collaborative input that customers staff has and continues to provide ArisGlobal,” said Simon Sparkes, Executive Vice President, ArisGlobal.

BUSINESS BENEFITS TO CUSTOMER

Flexible, Cost-Effective Clinical Trial Management

The solution is proving to be the CTMS that is enabling monitors to work closely with their study project manager in developing individual management plans for each of their centers. “Our customized CTMS is facilitating the efficiency and cost effectiveness of our processes,” said the customer. Study teams can now more easily set up studies and automate activities such as study planning, site assessments, document distribution, enrollment and site visit planning. New studies can be set up quickly and consistently by utilizing numerous global and study-specifiic templates available to them. Study conduct and closeout are also being handled more smoothly. A powerful document module is being used to ensure that all study-related documents are tracked and ready for regulatory submission. Study teams are also able to easily monitor and track the completion of milestone activities and tasks, and can ensure they are achieved before the study closes. Additionally, clinical trial teams can close site monitoring visits and update study statuses to refllect their progress. Ensured regulatory compliance is another benefit that the customer is receiving thanks to the system’s Trial Master File (TMF) functionality, which securely archives and stores all documentation. All issues can be tracked at all levels and closed with any trends identifiied for future trial activity to preserve information integrity through all the stages of the clinical trial process.”

Intuitive, Adaptive Data Management

Users appreciate agCapture’s intuitive and user-friendly interface, which includes help and messaging guidance, to ease them through their data collection efforts. Because their business often involves challenging therapeutic areas, this often involves large and complex study designs and case report forms (CRFs). The CRO users take advantage of agCapture’s Configurable Study Design module to quickly generate eCRFs by copying from a library of existing forms, CDISC-compatible templates or by creating new forms using a drag-and-drop design wizard. Forms can be designed to change dynamically based on the responses recorded for a given patient. Utilizing specific modules for complex, early-phase studies, the CRO can now easily handle large, multi-center projects. Due to the global nature of some studies, the customer is utilizing the system’s multi-lingual support for global studies, which translates forms into the native language of a site. Their users are also leveraging and evaluating agCapture’s out-of-the box, integrated module for IWRS/randomization and trial supply management system to automate the tracking of their global supply chain . What does the future hold for the customer? “We are now working with ArisGlobal on rolling out the integration of EDC and CTMS to our users,” adds the customer. “This will be a big plus for us in managing trials more seamlessly from end to end. Our users will have access to more timely and reliable operational data, which will help to reduce study timelines. The more that we can enter data once and then control and share it, the better we will be able to preserve information integrity through all the stages of the clinical trial process.”