InnovoCommerce LLC and FormsVision BV Partner to Provide Robust IRT Solutions for Global Pharmaceutical Industry

IRVINE, Calif.--(BUSINESS WIRE)--InnovoCommerce, LLC, developers of innovoPOINT®, the leading clinical and investigator portal solution, has formed a strategic alliance with FormsVision BV, based in the Netherlands. The partnership addresses the growing industry need for robust, flexible and economical integrated response technology (IRT) solutions to optimize clinical trial patient randomization, drug supply management and real-time clinical trial status monitoring and reporting.

“Cutting the cost of IRT solutions is key to academic research”

FormsVision BV, based in Amsterdam, the Netherlands, was formed to commercialize ALEA™, a Microsoft platform-based IRT software solution. Over the past two decades the Netherlands Cancer Institute as well as the European Commission funded and developed ALEA to facilitate clinical research. Originally a randomization program used by only four major clinical trial coordination centers in Europe in 1992, ALEA has grown to become a full-fledged IRT system currently used by over 40 academic clinical trial centers worldwide, running in excess of 400 trials, 4000 centers and over 200,000 trial patients, in almost all medical therapeutic disciplines.

“Cutting the cost of IRT solutions is key to academic research,” says Martin Ryan, responsible for business development at FormsVision. “The research budgets are under pressure, while the regulatory authorities expect the academics to conform to the same regulations as the pharmaceutical industry. This forces academic research groups to adopt process control systems that were exclusively used by the industry.”

Emile van der Donk, spearheading ALEA development, states, “A shared implementation effort by seven major academic research centers supported by the European Union has resulted in an industry-grade, validated and compliant IRT system with focus on cost-effectiveness and interoperability. Because it was developed in the clinical setting, our users were literally in the office next to us and feedback channels were very short, with clinicians coming into our office whenever there was a requirement or issue.”

The FormsVision and InnovoCommerce alliance provides a full-service model enabling a sponsor study team to quickly and cost-effectively set up and support a study in the ALEA system. To further reduce costs, customers running multiple trials can adopt ALEA in a SaaS model through flexible in-sourcing. Using this approach, the customer is able to take control over the whole process – from study setup to operational support – under the supervision of the alliance’s consultants. In either model, the ALEA solution can be seamlessly accessed via the innovoPOINT clinical and investigator portal for maximum sponsor productivity.

Pharmaceutical companies sponsoring clinical research can spend an estimated $50 million or more per year on IRT solution offerings, as the market for IRT solutions has been, until now, dominated by a small group of vendors. InnovoCommerce has identified a growing need for more flexible, cost-effective and agile solutions that boost quality, user experience and data integrity. This new partnership will provide highly robust, configurable IRT solutions available to the industry.

“We are very excited about the partnership,” states Daniel O’Connor, Chief Executive Officer of InnovoCommerce. “The industry needs this type of solution: one that can be set up, deployed and leveraged for multiple studies in an efficient and cost-effective manner. Moreover, as ALEA is developed in the flexible .NET framework architecture and was designed to integrate seamlessly with Microsoft SharePoint®, we will provide even greater value to our life science customers by providing a powerful eClinical solution, bundling advanced IRT with our leading innovoPOINT® clinical and investigator portal product.”

InnovoCommerce’s IRT program consultant Dave Holly has developed IRT solutions currently in use in the market. Holly notes, “Rapid IRT setup using standardized project templates is a core ALEA feature. But templates alone won’t save money if your IRT service group is still doing business ‘the old way.’ The ALEA platform has allowed us to change the way we run IRT projects to further reduce costs. This is the value-added service and experience InnovoCommerce brings to the table.”

The ALEA Solution includes the following capabilities:

True IRT platform with web and phone interfaces, utilizing the latest voice technologies
100% configurable, eliminating the need for custom scripting
SQL Server Database storing CDISC ODM XML
Extensive support for email, fax, SMS and XML web service confirmations
Comprehensive list of standard and custom reports
Secure system access predicated by user registration profiles and permissions
Over 20 years of continuous software development and validation, with three major upgrades
Seamless integration with the industry-leading innovoPOINT clinical and investigator portal solution

The ALEA solution is now available for pilot evaluation and commercial licensing. It can be deployed on premises or at InnovoCommerce’s partner network of SAS 70 type II, US-EU Global Safe Harbor self-certified, GXP-compliant national data centers.

About InnovoCommerce LLC

InnovoCommerce is focused exclusively on delivering new, innovative eClinical solutions for the global life science industry. The company’s innovoPOINT® product has been selected by nearly 50 percent of the world’s largest pharmaceutical companies for their enterprise-wide clinical and investigator portal initiatives. innovoPOINT helps pharmaceutical companies undertake and manage increasingly complex, globally distributed clinical trials in a cost-effective and efficient manner. InnovoCommerce also provides fully compliant managed hosting services to enable rapid deployment and utilization of the solution in addition to clinical system integration and validation services.