DRUG DEVELOPMENT:  Last Frontier of Automation
Millions have been spent by the pharmaceutical industry automating discovery. As commonly used by most people, the term "bio-informatics" now means computer assistance to discovery. Individual pharmaceutical companies have spent $10-20 million to automate and empower in vitro work with supporting technologies. This is where Electronic Laboratory Notebooks (ELNs) have gained the most market share and have the highest adoption rates. Scientists credit the ability to view, use and analyze their colleagues' work as a launch pad for new innovation. This is a primary plus for ELNs and ultimately pushes more work into the development phase.

Likewise, electronic data capture for clinical trials has received the attention of small software development companies and giants, such as Oracle. Numerous products are available for electronic data capture for clinical trials. Though adoption of this technology for clinical trials is slow, large pharmaceutical companies and contract research organizations (CROs) are embracing these technologies in clinical trials. Therefore, automation or computerization of clinical trials is dependent upon adoption of existing technology.

However, automation of the space between discovery and clinical trials, often referred to as development and / or pre-clinical, has been largely ignored by software developers and pharmaceutical companies. Most biological scientists in this space continue to use paper, spreadsheets, or small databases. Often, the choices of what to use are left to the individual scientist. Individuals in the same laboratory choose to use a mixture of these for different study types or different parts of studies. Historically, many of the laboratories conducting these biological studies (in-vivo studies) have used Laboratory Information Management Systems (LIMS). These LIMS are designed to, and do a good job of, capturing information from laboratory instruments. However, LIMS usually provide little or no help with study design and reporting.

Due to the automation and computerization of discovery and the adoption of electronic data capture for clinical trials, the bottle-neck for commercialization of pharmaceutical products is now in the development / pre-clinical space. The tools now used do not allow scientists to quickly test all of the potential drug candidates coming out of discovery, nor to accurately and quickly provide the best candidates for clinical trials.

The lack of automation of development / pre-clinical studies creates two other major, expensive problems:  1) Go-or-no-go decisions are often delayed or made on incomplete information because the data is not readily available.  2) When compounds fail in the clinical phase (or, worse yet, fail commercially), much of the data on which success in the clinical phase was predicted is not readily available for review and analysis to determine why pre-clinical results were misleading. Therefore, millions are totally wasted without improving the prediction model.

This surprising lag in implementing technology is due in part to the lack of technology to support the nuances of development and pre-clinical and the inability to link with data from the discovery and clinical phases. Electronic study management software, like eStudy™ from iAdvantage, fills this void.

Companies are now beginning to seek technologies that bridge the gap between discovery and clinical. Inertia of scientists, regulatory and security pressures, and finding the right tool to empower automation of study management and data collection are issues affecting the successful adoption and implementation. Before these companies can envision a return on their technology investments, questions surrounding study design, data capture, data storage, sharing data, and reporting have to be addressed.

Study Design and Management

  In designing and managing studies, study directors and project managers go through a similar process for each new study. Electronic tools do not take the place of the individual - people still have to set the requirements for organizing trials. However, electronic tools can support these functions, especially when the tools support the logical workflow they use.

Study directors and project managers routinely use templates and schedules to build studies. When these detailed forms are stored in a database and can be quickly pulled together, study start-up time is reduced. Likewise, easy-to-use wizards facilitate production of treatment lists, sample ID lists and labels, subject ID randomization, experiment-specific ELNs, etc.

Data Capture

  In many development laboratories, paper is still king. Scientists use pen and paper to capture measurements, observations, and instrument data. This is the way experiments have been done for decades. The adoption of electronic tools is slow in in-vivo studies.

"Currently, the vast majority of in vivo animal studies undertaken by life science research organizations are managed using paper-based notebooks, loose-leaf binders or Excel® spreadsheets," said Mike Elliott of Atrium Research and Consulting. "With the goal of streamlining biopharmaceutical R and D, we find this practice to be highly inefficient. Additionally, data from a range of highly automated analysis and collection systems must be transcribed by hand, leading to issues of data quality and throughput. We estimate that these outdated processes increase the costs of pre-clinical research from 15 to 25 percent."

In an online / telephone survey of 150 North Carolina pharma / biotech firms conducted by Wake Forest University, Babcock Graduate School of Management, 63 percent currently use Microsoft Excel® spreadsheets for their data management. These users were the least satisfied in terms of performance, efficiency and facilitation of the research process.

New software products called "Electronic Study Management Systems" are coming to market to help companies, specifically those in the development and pre-clinical space, automate the processes of study design, management and data collection. "These products will have a significant impact on streamlining throughput and enhancing the quality of data for pre-clinical research," said Elliott.

Data Storage

  Currently, most development / pre-clinical data is stored in paper notebooks in boxes in cabinets somewhere or in Excel® in someone's computer somewhere. Usually, no one can be exactly sure of the location of a given piece of data. Therefore, manual searches are routine, frustrating and costly.

CENSA asked 59 scientists to respond to the question, "How often do you need to locate data in an old notebook?" More than 35 percent said they need their old notebooks more than once a month after conducting the initial research. Just think of the inefficiencies from not being able to use, share and analyze this information. By continuing to use a paper-based system, scientists are losing intellectual property and a significant knowledge repository.

With modern tools designed specifically for the development / pre-clinical space, data saved immediately into and stored in large relational databases, such as Oracle, is secure, queryable and available.

Data Sharing and Reporting

  With scientists using paper notebooks, data sharing is an issue. When data is put on paper, it is essentially lost. According to Rich Lysakowski, Ph.D., Executive Director of the Collaborative Electronic Notebooks Consortium (CENSA), "Unless data stored on paper is carefully indexed, it is lost to everyone but the original author(s). Over time, the authors eventually forget the details of their work." Some companies admit to repeating studies because they cannot find the data from previously-completed studies.

Lysakowski added that paper data capture is archaic. "The manual cutting and pasting of data and instrumental printouts into notebooks using scissors and cellophane tape is still a very common practice in modern laboratories."

Transcription Time and Errors Eliminated
Ensuring data accuracy and ease of reporting are additional benefits of electronic tools. CENSA's Lysakowski pointed to a survey by the "R&D Team Computing Study" where scientists were asked, "How many minutes per week do you spend transcribing data from all sources into paper notebooks?" Responses showed that 25 percent of the scientists surveyed spent more than five hours per week doing data transcription, constituting a full one-eighth of a 40-hour work week.

Even the most staunch paper users can see the benefits of moving to electronic study management. Paper data capture creates "islands of information" that limit interaction, collaboration, study speed and, eventually, speed to market. These data silos create storage rooms of notebooks that scientists may or may not review in future studies.

By using an ELN that is an integral part of an Electronic Study Manager, a company can eliminate transcription time. Instruments and data sources can be directly linked to the experiment-specific ELN software so that ELN forms are electronically populated. This, in turn, eliminates transcription errors.

Communication Via the Web
Communication is further improved with the use of a web-based Electronic Study Manager. Via the web, scientists and business managers can quickly and easily share information in the central database in real time that would normally require digging through someone else's paper notebook.

Saving Time and Money

  Inefficiencies Eliminated
With study managers relying on paper and limited electronic tools, such as Excel®, it is not surprising that there are numerous inefficiencies. Having coordinated technology tools can dramatically improve data collection, sharing and communication, especially when multiple scientists, sites and treatments are involved. Products that serve as Electronic Study Managers are helping to shape the way study directors and project managers approach study design and management. These tools have built-in technologies that allow for on-demand information exchange, data sharing and reporting, thus saving time and money.

Time-to-Market Reduced
Time-to-market is dramatically lengthened by inefficiencies and errors in paper systems. Using an Electronic Study Manager helps ensure that a study is set up correctly, all scientists have access to study information, and that treatments, observations and sample collections are carefully and quickly conducted. The ability to access all study data immediately and to prepare interim reports can help flag problems. Having an early assessment of the feasibility of a drug moving successfully through development and pre-clinical into clinical trials can save a company time, market share and money. Lastly, having final reports available within hours of study completion, rather than days, weeks or even months later, accelerates candidates into clinical trials.

eStudy™ - A Complete Solution

  iAdvantage's eStudy™ follows the same logical study flow that scientists employ and helps speed development and reduce inefficiencies by automating study management.

iAdvantage's flagship product is eStudy™. From 20 years of hands-on, practical experience in the development space, its scientists and developers created eStudy™ to help bridge the gap between the discovery and clinical phases by automating existing workflows. eStudy™ allows scientists to quickly design studies, dynamically design electronic notebooks for data capture and to share, analyze and react to information throughout the data collection and study management process by:
  • Eliminating paper systems and "islands of automation"
  • Automating study design and data collection
  • Integrating with databases, instruments and statistical packages
  • Generating reports on demand
This type of solution also provides real-time insight into study activity and, through faster reporting tools, helps drugs move through development to regulatory submission more quickly.

iAdvantage has been working with scientists for more than a decade during which its software has been deployed within leading life science companies in Europe and North America. eStudy™ allows study directors to set up, track and report studies in exactly the same fashion - from a process perspective - as their traditional work flow. It provides the ability to gather and share information in real time, eliminating transcription from paper and eliminating transcription errors. eStudy Publisher™, iAdvantage's comprehensive reporting feature, helps companies shift resources away from full-time reporting responsibilities.

"By eliminating paper systems and 'islands of automation', we help scientists improve communication, increase productivity and reduce time to market," said Dr. Fate Thompson, President and CEO of iAdvantage. "The software's unique, patent-pending reporting tool allows critical business decisions, such as product go/no go, to be made at any point in the study life cycle, preventing the waste of critical resources."

iAdvantage tools are user-friendly and follow an information hierarchy that makes it easy to access and interact with data. eStudy™ integrates with other databases for on-demand information and document generation. With iAdvantage's software, data are centralized, auditable and secure from collection through reporting. eStudy™ is also validated to GLP and 21CFR Part11 specifications.

eStudy™ helps organizations move products faster through the development process, increasing the return on their technology and resource investments.

"What I love about iAdvantage eStudy™ is the ability to instantly see, hear and view what is happening with data capture," said Peggy Bruton, Residue Specialist II in the Dietary Safety Division at Syngenta's North American headquarters. "We have the ability to easily run reports to see what the data looks like. Another bonus is the back-and-forth communication - we learn things as we go, react to items that are out of line or interesting, and change course based on the information that is gathered."

eStudy's reporting feature also delivers time and cost savings. "Given the ease and flexibility of report template creation and electronic access to all data, study reports that used to take us days or weeks to prepare can now be ready in minutes," said Bruton.

For years, iAdvantage has worked to help scientists in the development and pre-clinical space manage studies. These iAdvantage technologies meet regulatory demands and accommodate changing needs in support of best practices. For companies seeking an electronic study manager, iAdvantage's eStudy™ solution offers easy study design, experiment-specific electronic notebooks, streamlined and integrated data collection and unmatched reporting.

Sources

  About iAdvantage Software, Inc.
iAdvantage creates value for its clients by improving data communication, productivity, real-time business intelligence and time to market. This is achieved through the use of the company's electronic study management software for development and pre-clinical life science studies (pharmaceutical and biotechnology). With eStudy™, scientists increase their productivity in study design, eNotebook design, data collection and data reporting, while saving time and money and maintaining data integrity (complying with GLP and 21 CFR Part 11 regulations). iAdvantage is headquartered in Cary, North Carolina, near the life science and biotech hub of Research Triangle Park. More than 140 life science companies in North America and Europe use the company's products in research and development. For more information, please visit www.iadvantagesoftware.com or call 919-469-3888.

"Comparing Paper and Electronic Laboratory Notebooks - Part 1 and Part 2" by Rich Lysakowski, Ph.D.