Mastering mid-study changes: ICON clinical research draws on Medidata Rave® for smooth data migrations

By Medidata

The Challenge

Most major clinical trials today utilize electronic data capture (EDC) systems, which are configured to handle the specific requirements of a trial’s protocol and provide clinical sites with a computerized system for data entry. However, many clinical studies today are changed mid-stream – during the time when patient data is being captured and entered – because of modifications in research design, regulatory questions or other developments. Such modifications can require data entry to be halted while the trial administrator rewrites the computerized case report forms and moves data previously collected.

As a global contract research organization (CRO) with over 15 years of experience in a range of therapeutic categories, ICON Clinical Research has long recognized that many clinical trials undergo mid-study changes. Those that result in new electronic case report forms (eCRFs) require a data migration – the transfer of already-entered trial data to the proper fields in the revised eCRFs. Trial managers often find they need to conduct not just one, but a series of migrations before all data is transferred successfully. Data transfers must be carefully planned and executed to ensure that all data is properly mapped while also avoiding trial disruption.

To manage migration risks, ICON Clinical Research has mobilized its clinical team around a comprehensive migration process that leverages the capabilities of the Medidata Rave EDC system. ICON Clinical Research had encountered the typical obstacles using a variety of EDC platforms, which brought risks of downtime, data transfer errors and the need for manual reconciliation. But while mid-study changes can disrupt studies in other systems, Medidata Rave provides built-in tools to handle changes with minimal effort and no system downtime.

“With a typical trial lasting anywhere from 12 to 48 months, protocol amendments and other trial changes can be inevitable,” said Debby Holmes, Vice President of Clinical Operations and previously Global EDC Champion for ICON Clinical Research. “Therefore, implementing an EDC tool that facilitates smooth and easy migrations is critical.”

A long-time user of Medidata Rave, ICON Clinical Research made use of Rave’s robust migration capabilities while conducting a Phase III clinical trial for an endocrinology treatment developed by a global pharmaceutical company. The trial involved nine sites, 571 subjects and 87 eCRFs, and underwent mid-study changes that required a migration. Gleaning insights from its new migration review process and leveraging Rave’s enhanced migration tools, ICON Clinical Research successfully completed the data transfer with just one efficient migration.

The Medidata Difference

As a member of the Medidata ASPire to Win® program, which trains and accredits CROs and other service providers on the Medidata Rave platform, ICON Clinical Research has undergone in-depth training and managed numerous Rave studies to become expert in delivering Rave-related services. Having attained the Rave Accredited Plus level, ICON Clinical Research can serve as a sponsor's one-stop shop for Medidata Rave services.

As a seasoned Rave user, ICON Clinical Research was looking forward to leveraging Medidata Rave’s updated migration capabilities. Because Medidata’s Amendment Manager enables users to automatically generate a detailed planning and execution process, ICON Clinical Research could efficiently manage mid-study changes with analysis tools and configured edit checks and quickly determine differences between study versions. Because Amendment Manager runs without taking the EDC system offline, study managers can efficiently deploy selected changes without the downtime that other systems might incur. ICON Clinical Research was able to edit, move and store study designs offline, providing an automatically-generated study specification. Moreover, Rave uses XML files to download fields and forms, reducing manual activity and lowering risk of human error. With Rave’s version management capabilities, study changes are immediately available upon publication.

ICON Clinical Research also took the initiative to become familiar with migration resource materials available in MyMedidata, an online community that keeps Medidata customers and ASPire to Win partners informed with product news and technical documentation. Key resources included Medidata’s migration plan document and checklist, which ICON Clinical Research customized based on its organizational structure.

“The additional specification documents that Medidata provided really helped us understand the migration process and plan for a hassle-free execution,” said Evan Hughes, Data Management Project Manager at ICON. “The introduction of Amendment Manager and Rave’s study import and export capabilities decreased time requirements and frustration during pre-migration testing and post-migration activities.”

The Results

ICON’s migration was on time, on budget and the sites were impressed – a success by all measures that demonstrated best practices in partnering with Medidata. Results included:

• Speedy Migration – The migration was completed in one week, including one day laying out the specifications, one day programming, one day of testing, one day of UAT and one day of running the data transfer.

• Seamless Site Experience – Thanks to ICON’s thorough preparation, all data was migrated with one efficient migration, avoiding trial disruption and ensuring a seamless experience at the sites.

• Independent Execution – Complementing ICON’s deep industry experience, Medidata’s partner enablement program provided ICON Clinical Research with in-depth training and resources that positioned ICON Clinical Research to independently conduct the migration without requiring support from Medidata.

• Sponsor Satisfaction – Marking an improvement over previous migrations, some of which took up to three months and required subsequent migrations, the client was very satisfied with the migration results.

The Road Ahead

“When ICON Clinical Research and Medidata first sat down, ICON Clinical Research had little experience and exposure to EDC. Now with four years of EDC experience under our belt, the relationship has matured from ‘let’s implement EDC’ to ‘let’s improve everything about EDC together,’” said Holmes. “Based on our positive experiences with these migrations, we have developed a comprehensive working procedure with the Medidata team.”

ICON Clinical Research and Medidata initiated bi-weekly reviews of all trials to identify trends and share best practices. ICON Clinical Research reorganized some of its team to optimize roles to the EDC trial and created a new role focused on identifying process improvements and communicating EDC best practices across the organization. ICON Clinical Research also created its own online community for sharing Rave-related materials to unite its global teams around EDC.

ICON Clinical Research believes that Medidata Rave is central to its clinical trial toolbox and plans to deepen the partnership with Medidata. “ICON Clinical Research has enjoyed more than four years as a partner with Medidata,” said Holmes. “We intend to continue to leverage Rave technology where it best benefits the clinical trial.”

About ICON Clinical Research

ICON Clinical Research specialises in the planning management, execution and analysis of Phase IIb-IV clinical trials, ranging from small studies to complex, multinational projects. It is a division of ICON plc, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. ICON provides strategic development, management and analysis of programs that support clinical development – from compound selection to Phase I-IV clinical studies. ICON teams have successfully conducted over 1,900 development projects and over 2,300 consultancy engagements across all major therapeutic areas. ICON currently has approximately 6,500 employees, operating from 71 locations in 38 countries.

About Medidata Solutions Worldwide

Medidata Solutions (www.mdsol.com) is a leading provider of clinical trial solutions that enable the world’s most advanced life science organizations to maximize the value of their clinical research investments by putting powerful tools into researchers’ hands. A pioneer since 1999 in innovative technologies for planning and managing clinical studies – including protocol design; clinical data capture, management and reporting; and trial contracting and negotiation – Medidata Solutions and its global network of business partners address the unique needs of sponsors and sites of all sizes. With deep expertise in conducting studies across all phases and therapeutic areas, on six continents and in more than 80 countries, Medidata Solutions helps clinical researchers safely accelerate the process of bringing life-enhancing treatments to market.