Axcan extends use of Medidata Rave as EDC and CDM system

Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today announced that Axcan Pharma Inc. (Axcan) has extended its use of Medidata Rave^® as its electronic data capture (EDC) and clinical data management (CDM) system, bringing study build and execution into the organization through Medidata training and mentoring.

“It was clear from the start that our Medidata team not only understood but quickly responded to the challenges we faced in introducing EDC and evolving our clinical development processes”

Axcan researches, develops and markets innovative products for the treatment of gastrointestinal diseases, including inflammatory bowel disease, irritable bowel syndrome, cholestatic liver diseases and complications related to pancreatic insufficiency. Since standardizing on Medidata Rave in 2007, Axcan has realized significant cost and time savings, including reducing study build time from 12 to six weeks through the use of Rave's Global Library and reducing time to database lock from two months to three weeks. Based on the ease of use and simple set-up of the initial three Rave studies, which were built and executed by Medidata professional services, Axcan management decided to gain further control of their future studies by bringing the study functions in-house.

Medidata has created a simple and collaborative path for organizations to bring eClinical technologies in-house, with standardized study life-cycle processes, intuitive technology interfaces and supportive eLearning and mentoring available on an as-needed basis.

"It was clear from the start that our Medidata team not only understood but quickly responded to the challenges we faced in introducing EDC and evolving our clinical development processes," said Roxane Aubray, director of clinical operations, Axcan. "Working closely with Medidata, we have made significant strides in streamlining our clinical operations and expect to see further returns on our investment when we complete the knowledge transfer and bring Medidata Rave implementations fully in-house."

In 2007, to achieve greater efficiencies and reduce the time involved in both study build and data cleaning, Axcan looked to begin using EDC for the first time. After evaluating three EDC solution providers, Axcan management selected Rave as its enterprise-wide system based on its robust and easy-to-learn functionality and its implementation team experienced in helping first-time EDC users. Axcan was also impressed with Medidata's collaborative approach, deep technical expertise and comprehensive support.

Axcan improved efficiency under the Medidata Study-by-Study model, where trials are implemented by Medidata. The combination of training, which included eLearning and consultative mentorship, enabled the Axcan team to quickly build its first study in EDC and meet the aggressive deadline for launching their first Rave study. The benefits gained inspired Axcan's clinical team to bring Medidata Rave implementation in-house through knowledge transfer. Bringing Rave skills in-house will give Axcan the opportunity to control, build, manage and administer studies internally, giving the pharmaceutical greater control of their vital clinical research programs.

Axcan has found that Rave's robust technology provides additional efficiencies beyond automation of existing processes. It has allowed the company to revamp its trial processes, with guidance from Medidata's best practices, to reduce required resources and speed the ability to complete clinical work on drugs in development. With Global Library, a tool for storage and retrieval of previously created electronic case report forms, Axcan is able to streamline the process of building multiple studies and extend the benefits of electronic trials by turning studies into reusable assets. Moreover, Rave easily integrated with Axcan's existing interactive voice response system (IVRS) and central lab systems, making the transition seamless. The integration of EDC with clinical trial management software (CTMS) is now under development.

"Through the expanded use of Medidata Rave, Axcan continues to demonstrate its commitment to strengthening its research process while reducing costs and protecting its clinical assets," said Tarek Sherif, chairman and CEO, Medidata Solutions. "We look forward to working closely with Axcan through the next stage of its strategy to streamline its clinical development processes."