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By Salvatore Salamone

February 18, 2004 | Scientists at specialty pharmaceutical developer Berlex Laboratories spent too much time cutting and pasting. Old-style. They would print out pages of computer-generated data, reduce the pages on a photocopier, apply scissors, then paste the trimmed pages into a traditional lab notebook – and then have to track down that notebook three months later when the information was urgently needed. An internal study indicated that company scientists spent about 14 percent of their time putting data into a paper lab notebook.

The company knew it needed a new system to collect data electronically but wanted an approach that would let researchers continue using their existing Word and Excel files for recording experiment results. That’s one of the reasons Berlex chose to build its global R&D information management system on the Documentum Enterprise Content Management (ECM) platform. (Documentum recently became a division of storage giant EMC.)

Support for the existing data collection routines (entering data into Word or Excel files) was very important in getting researchers to use the system. “We let the users design the system,” says Charlie Sodano, Berlex’s manager of information services. When introducing the system to a department, “we would hook up the users with a [Documentum] developer,” Sodano says, so staffers had lots of say about what data are collected and how.

One group knew exactly what it wanted. “They wanted the searching to be more comprehensive, and they wanted more fields that would track information and relate [it] to other work in the company,” Sodano explains.

Berlex decided to use keyword searches rather than full-text searches, an approach that requires much more disk space. “If you index everything [for a full-text search], you need roughly double the disk space,” Sodano says.  “As long as you design your metadata well, people don’t have to do full-text searches.”

Documentum ECM typically runs on an application server, and requires plenty of storage space for documents, but does not usually require major hardware upgrades.

Berlex could quickly customize the application because Documentum ECM works closely with Microsoft Office. Using Visual Basic, the company can design Office forms and templates for collecting data. Such support proved valuable because Berlex’s researchers routinely use Word and Excel to capture information about their experiments. Chemists, for example, record experiment parameters in Word documents. Biologists doing high-capacity screening prefer Excel spreadsheets. “They might have thousands of chemical compounds and thousands of results,” Sodano says.

Faster Filing of Patents and Drugs
Patent application preparation is one of the processes that have been accelerated at Berlex. The system helps by collecting and time-stamping all information, but more importantly, researchers can do a keyword search and quickly find all the documents needed to support an application.

At Berlex, FDA submissions begin with copying all documents associated with a new drug into a Documentum repository, where they can easily be found at filing time. Documentum does not shun paper, which is required by the Berlex legal department. Paper versions of documents are bar-coded and stored offsite; the corresponding bar codes are included in the electronic (PDF) versions stored in the Documentum repository.

Researchers also go into the system when they start a new project. Using keyword searches, a scientist can find all the previous work done in a specific area. When paper notebooks were widely used, the scientists had to track down specific lab books filed away for safekeeping.

“There are big gains for departments that do repetitive work,” Sodano says. For example, a researcher starting a new experiment can use a form that already contains information, such as equipment configurations, that would otherwise have to be duplicated.

“If [scientists] need information for a report or presentation, they can cut and paste, reducing the time it would have taken to copy the information from a paper lab notebook,” Sodano says.

Berlex’s Documentum system currently holds more than 40,000 documents, and supports researchers in the U.S., Japan, and Germany.

Addressing user concerns up-front made the rollout of the information management system much easier. “It started as a voluntary project,” Sodano says. “But by word of mouth, and with a little training, we quickly had about 80 percent of the researchers using the document management system as an alternative to paper lab notebooks.”


For reprints and/or copyright permission, please contact  Terry Manning, 781.972.1349 , tmanning@healthtech.com.