Phase Forward, a clinical trial suite, recently announced a new submission checking service offering based on its web submission data manager (WebSDM) application. Developed under a cooperative research and development agreement between the FDA and Phase Forward’s Lincoln Technologies safety division, WebSDM gives organizations a means for testing FDA submissions for compliance with the Clinical Data Interchange Standards Consortium’s (CDISC) Study Data Tabulation Model (SDTM) standard.

NextDocs, a provider of regulatory document and quality management software recently announced a strategic partnership with Extedo, an electronic submission management solutions provider. This partnership allows the companies to offer a combined solution for document management and regulatory submissions. “Extedo’s eCTDmanager Compliance Suite is a comprehensive and easy-to-use regulatory submission management system for the assembly of ICH eCTD compliant electronic dossiers.” said Zikria Syed, CEO, NextDocs. “Integrating it with NextDocs adds significant value to our offerings.” “NextDocs document management is a leading edge, web-based document management solution. It extends the capabilities of Microsoft Office SharePoint Server to meet the regulatory and compliance requirements for 21 CFR Part 11,” said Lee Knoch, president and CEO, Extedo. “Customers are demanding open, extranet capable and easy-to-use solutions like NextDocs document management.”

Medidata Solutions, a provider of electronic clinical data capture (EDC), management and reporting solutions, has announced that Chiltern, a full service contract research organization (CRO), has signed as a partner through Medidata’s ASPire to Win Program. With this partnership, Medidata will provide the tools and training that will enable Chiltern to implement Medidata Rave to manage the company’s global Phase I-IV clinical development and late phase programs. Chiltern provides necessary technical project management, team training and site level training in support of EDC implementation and adoption. Chiltern’s dedicated EDC services to sponsors range from pilot programs to support of enterprise-level implementation. The company is looking to expand its service offerings, and after a review of the leading EDC vendors, Chiltern selected Medidata Rave.

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