Software developer ePeople Inc. will announce a new version of CTMail, its e-mail management system for clinical trials this week.
According to a recent survey commissioned by ePeople, the highly-trained professionals who are managing clinical trials spend 70 percent of their time searching e-mail, cutting and pasting relevant information from old e-mails into new e-mails, and worrying constantly about who must receive or respond to e-mail.
The new release of CTMail can manage e-mail from multiple trials and sites from a single user interface. It also captures some of Outlooks task management features. Since announcing its first CTMail application in July, ePeople says six customers have signed on, including McKesson BioServices, BridgeSite Clinical Research and ClinDatrix.
Studying the effects of drugs on people is by far the most expensive part of bringing a drug to market: It accounts for an estimated $470 million of $800 million, according to the Tufts Center for the Study of Drug Development, not including post-marketing research. Inefficient decision making, lack of information sharing, and time-intensive archiving all contribute to this cost. Using e-mail could decrease it, said ePeople CEO Anthony Lye.
Federal regulations require that communications, including e-mail, between a drug sponsor and clinical trial site be copiously documented. But much of this correspondence resides in files of individual workers, who are usually required to print out copies of e-mails each week and physically place them in various study binders. Since clinical research associates typically receive 1,000 e-mails every week, the task takes hours, Lye said.
CTMail promises to automate this process, which is one of the reasons why Sarah Morrone, associate director of clinical operations at CV Therapeutics, signed up for it. People qualified to monitor clinical trials are in high demand, she said, and turnover is high. When people leave, companies can lose access to e-mailed correspondence. She expects to begin using CTMail in one or two trials next quarter.
CTMail stores information in a central, searchable database using XML tags that are applied both automatically and manually. "Weve built a server that interprets all the Outlook functions in a business context. So when youre sending and receiving e-mail, it stores e-mail by trial and by site," Lye said.
According to users access, people can track, report, and search their own and other peoples communications across the database. CTMail can be integrated into any business e-mail application, Lye said.
"E-mail represents a terrible problem for most clinical trial sponsors because people are too casual with it," said Sandor Schoichet, a consultant with S. Ross and Company specializing in clinical data management. Typical problems with e-mail involve uncertainty about which version of a document to use, lack of encryption, and sending documents to unauthorized recipients. Schoichet said he has not yet seen CTMail, but he said that the idea sounded useful.
However, he recommended against using e-mail at all for many management tasks. Tracking protocol updates, document versions and certain adverse events require a more controlled environment, such as a portal, he said.
Morrone said other non-e-mail tools are essential, but so is a tool to track correspondence. "You need to show that youve made appropriate decisions, that you know whats happening in the field."
She particularly likes a CTMail feature that prevents an e-mail string from being tampered with. "Its more than an archive, it has a built-in audit trail, so that if someone attempted to change an e-mail chain, its very obvious." CTMail can also track attachments sent via e-mail.
Lye, ePeoples CEO, said most of CTMails competition came from in-house IT efforts. Morrone said she had had been looking unsuccessfully for an outside service when ePeople contacted her. "Its the first time in months that Ive returned an unsolicited phone call," she said.