BioStata invests in KIKA's Veracity advanced EDC platform

KIKA™ Clinical Solutions, the leader in advanced EDC solutions for Clinical Asset Management™, announced that Denmark-based CRO BioStata ApS has made a seven-figure investment in KIKA technology to provide its Veracity™ advanced EDC platform to biopharmaceutical clients in Europe.

“Veracity addresses DMC and adjudication issues, which is of critical importance when dealing with life threatening circumstances”

BioStata specializes in statistics and worldwide EAC and DMC/DSMB services for pharmaceutical companies. It offers a complete SOP system and a large network of clinicians and statisticians to ensure a high level of service for companies under EMEA and FDA domain. BioStata signed a technology service agreement with KIKA last spring.

Bjarne Bodin, CEO of BioStata, said, "In our experience no other EDC platform offers Veracity™'s flexibility, capability and security, and KIKA improves the technology continually. We made this significant investment in the Veracity™ platform because it offers unique capabilities such as online event adjudication and because its team truly understands how to help pharmaceutical sponsors use eClinical technologies and strategies to conduct faster, safer, less expensive clinical trials. Together we are uniquely positioned to build a strong market."

Mr. Bodin added that BioStata ApS will move its headquarters to a larger office space near Copenhagen center, to accommodate the company's growth as more sponsors adopt eClinical technologies such as Veracity™.

KIKA's CEO Linda Beneze said, "Large pharmaceutical companies adopting DMC/DSMB need fail-safe, validated systems. BioStata's excellent CRO expertise combined with KIKA's advanced EDC platform will deliver a fail-safe solution that enables sponsors to make the best use of their clinical trial data."

Large pharmaceutical sponsors are adopting Veracity™ because it fits a critical need. They all struggle with the same problems. They need a reliable, automated data collection system to use across their major studies to free them from having to deal with time-consuming, expensive manual work such as adjudication, binding, and ensuring that documentation is complete and accurate.

BioStata has a strong expertise in DMC and adjudication committee workflows. BioStata is working with large as well as smaller pharmaceutical companies in this field and has just finalized a deal making them the preferred DMC provider for a global pharmaceutical company. "Veracity addresses DMC and adjudication issues, which is of critical importance when dealing with life threatening circumstances," Mr. Bodin explained. "It is a proven, unique system unlike any other I have seen, and we are complementary in terms of technology and staff expertise."

Zaher El-Assi, KIKA Vice President, Global Sales and Strategic Partnerships, along with Erik Falvey, KIKA's Business Director for Northern Europe, are the architects of the KIKA-BioStata agreement. Mr. El-Assi explained, "For sponsors that already have an eCRF capability in place, BioStata will offer Veracity™ as an add-on to handle DMC/EAC workflows. There are major advantages to Veracity™ that will ease handling of the DMC/EAC and allow sponsors to incorporate eCRFs. It is a tremendous advantage to have a hosted EDC solution offered by such an experienced CRO."