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E-Mail in Clinical Trial
Management Survey Reports that 70% of a Clinical
Research Analysts Working Week is Consumed by E-Mail
ePeople Selected by Six Life Sciences Companies to More Effectively Manage
and Process E-Mail Information
Mountain View, Calif., December 7, 2004 - A staggering 70% of a clinical research
analysts working week is spent dealing with e-mails, according to an E-Mail in
Clinical Trial Management survey conducted by The Wren Group, a biotech consulting
firm and ePeople, a leading provider of e-mail management solutions for high value
customer relationships in life sciences, high technology and engineer-to-order
industries.
With e-mail dominating communications, life sciences companies are recognizing the
need to more efficiently manage and process e-mail information. ePeople today
announced six new customers in clinical trials including McKesson BioServices,
BridgeSite Clinical Research and ClinDatrix.
"E-mail is the most prevalent
form of communication used today, however, it must be managed effectively to be an
asset rather than a liability," said Anita M. Dopkosky, RPh, Vice President, Sales
and Marketing, McKesson BioServices. "ePeople's e-mail management solution will be
key to tracking this informal communication, as well as improving responsiveness and
the overall business process."
The four-month industry-wide E-Mail in Clinical Trial Management survey, which included
116 respondents from all levels of participants within the clinical testing field,
examined how e-mail is used in the monitoring and supervision of clinical trials.
The survey reported that clinical research analysts manage a time-consuming 1,000 e-mails
every week. It revealed that these e-mails are managed locally in personal files and
folders. In addition, there is no access to data for site auditing and monitoring is
ad-hoc. Therefore, all of the critical information from patient recruitment and
drop out to adverse event reporting and payment requests, is contained within the
uncontrolled e-mail environment, subject to each individual's personal filing and folder
system. This type of system doesn't allow managers to access the data held on their
clinical research analysts computers, forcing them to rely upon weekly reports which
may or may not be completely reliable.
The survey also reports that a clinical research analyst may monitor up to 20 trials
and/or 20 clinical sites and spend countless hours cutting and pasting information to
site and trial-specific data stores.
"E-mail communication plays a key role within clinical trials, however, it's apparent from
the survey that the flow of this time-sensitive and confidential data needs to be better
managed and controlled," said Anthony Lye, CEO, ePeople. "The pharmaceutical industry
would benefit tremendously from an e-mail management solution that streamlines communications,
centralizes information, manages expertise and provides a collaborative workspace for
efficiently resolving clinical study issues."
Survey respondents provided valuable insight by identifying the leading issues associated
with e-mail. The top five primary problems are summarized below:
- Inadequate management and processing of e-mail information from the sites, clinical
research analysts, monitors and investigators to the sponsors, clinical research organizations,
etc. Knowledge locked in personal files and folders, requiring endless cutting and pasting is
cited as the root cause of this problem.
- Lack of management access to essential and often critical study and site information.
For example, the mention of a possible unexpected adverse event within the body of an e-mail
might not be noticed by monitors or copied to other interested parties in real time.
- E-mail communication inefficiencies lead to delayed decision-making by senior management.
It has been estimated that every day in a 1,000 patient pivotal Phase III study may cost the
sponsor more than $100,000. Decision makers have no way to measure the responsiveness of
various groups nor the progress being made on critical issues.
- Inability to merge information contained in e-mail with the clinical trial management
system and electronic data capture software. Managers were frustrated with the ad hoc and
inefficient processes adopted by each monitor.
- Potential for serious noncompliance with regulatory requirements because there are
currently no guidelines available and little standardization of process among employees,
contractors and outside vendors. Only two percent of respondents had formal email compliance
policies.
About ePeople
ePeople is a leading provider of business email
management solutions for high-value customer
relationships in Life Sciences, High Technology,
Financial Services and Engineer-to-order industries.
ePeople's solutions for account management, site
management, customer support and team selling, provide
visibility and accountability to content, people and
processes. ePeople solutions are designed for rapid
adoption delivered on-demand or on-site and integrate
with Microsoft Outlook, CRM, email, IM and the web.
ePeople customers, including companies such as Cisco
Systems, Cognos, McKesson BioServices, Network
Appliance, InstallShield, and Openwave Systems, enjoy
significant gains in compliance, productivity,
responsiveness and quality.
NOTE: ePeople and the ePeople logo are trademarks of ePeople, Inc. All other trademarks are the property of their respective owners.
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