DZS Software Solutions, a Bound Brook, N.J.-based specialty provider of clinical data and trial management software services and solutions, has developed the ClinPlus Clinical Platform, a cohesive product that includes both EDC and CTMS features.

The ClinPlus Clinical Platform features include role-based security, role-based system/project views, 21 CFR Part 11 compliant audit trails and electronic signatures, customizable dashboard with an extensive library of metrics, auto emailing, alerts, standard and ad-hoc reporting.

Bob Borysko, vice president of business development of DZS Software Services, said, "The goal of the EDC initiative was to provide a complete set of features to facilitate the efficient definition of the clinical databases, eCRFs, and query logic by your in-house teams with an intuitive end-user interface for site-based data entry, query resolution and monitoring."

Some of the advantages of the new ClinPlus Clinical Platform include:

• Integration issues and risks between CTMS and EDC functions are eliminated as patient enrollment and visit tracking, site payment triggers and alerts relied on by the clinical project managers are supported via central databases utilized by the entire clinical platform.

• EDC features immediately can be enabled for sites based on green lighting through the CTMS features.

• Common, structured communication logs (study and site blogs), as well as documents are made available to all authorized team members.

• Limitations in data sharing inherent in integrated solutions are eliminated in a cohesive solution resulting in a broader array of available metrics to provide improved insight and early detection of issues.

• Project managers, directors, CTAs, CRAs, investigators, coordinators and data managers, etc. use a single, unified clinical platform for both CTMS and EDC significantly reducing system administration, support requirements and licensing costs.

• DZS Software Solutions can license only the EDC or CTMS component needed, along with the web services APIs, to integrate with existing EDC, CTMS and IVRS products.