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announces the debut of DocManager v2SM–a technological initiative developed in direct response to industry demand for secure, web-based systems solely devoted to managing timely and cost-efficient translation, regulatory approvals, and distribution of patient recruitment and retention materials around the world.
The task of managing translations and securing regulatory approvals in every study country is often fraught with miscommunications and errors that lead to production delays and cost overruns. Aiding and abetting this problem is the fact that existing entities charged with managing ethics committee (EC) submissions relegate patient recruitment materials to the bottom of the queue, given their first priority of managing protocol approvals within a given country.
“The inability to predict, or govern, how long global ethics committees will take in the review process means that if you make one mistake along any step of the way, you can end up doubling or tripling the development time of materials for a given country, hindering patient recruitment efforts and delaying time-to-market,” said Matt Kibby, global operations leader for BBK Worldwide. “BBK is now in a position to not only develop, but also to take full accountability for EC submissions and tracking of patient recruitment materials, elevating its importance by eliminating the competitive forces that prevent the study community from attending to this critical task,” he added.
Through its patented methodology, DocManager v2 facilitates optimal workflow within a closed and secure web-based environment and ensures that documents are organized for various levels of review to avoid the common, time-consuming pitfalls that delay project implementations. Documents and materials are locked by DocManager v2 and cannot be distributed until final approvals are received through an inherent system of checks and balances. A document “check-out” feature keeps users aware if other colleagues are working on a given document. Meanwhile, date and time stamps facilitate accurate predictions of development timeframes to help to quickly address workflow problems. The intuitive interface of DocManager v2 also follows a “tree structure” familiar to users of the ubiquitous MS Windows® system of primary and subordinate virtual folders.
“It does all this using an intuitive drag-and-drop interface that facilitates user understanding of the flow of thousands of documents–so it actively teaches best operating procedures to everyone involved,” Kibby said.