In an effort to improve patient care, increase research efficiency, and ensure regulatory compliance, Atlantic Health is transforming its paper-based clinical and drug trial process into a digital one. A process that used to constitute reams of paper forms scattered about administrative, physician, and finance offices will soon be facilitated by a fully integrated, Web-based solution developed on Microsoft® Office SharePoint® Server 2007. The solution features electronic forms, custom workflow processes, and a centralized data repository. Atlantic Health will use the solution to streamline, standardize, and expedite its clinical and drug trial management process. As a result, the productivity of those conducting and administering trials is projected to improve, sensitive research-related data will be more manageable and secure, and the company expects to conduct more trials each year.
New Jersey–based Atlantic Health operates two acute-care hospitals with specialties in pediatrics, oncology, orthopedics, rehabilitation medicine, women’s health, cardiovascular care, and neuroscience. The healthcare trendsetter boasts nationally recognized physicians, world-class facilities, state-of-the-art equipment, and innovative medical treatments. In their efforts to continually improve patient care, operating efficiency, and information management, Atlantic Health leaders recently recognized an opportunity to streamline the company’s clinical and drug trial procedures.
“When it comes to clinical and drug trials, there are numerous procedures, stakeholders, and data,” explains Jacque Brodt-Suggs, Director of Application Support at Atlantic Health. “If we can streamline the process and better manage the information stemming from these trials, we can ensure regulatory compliance and ultimately improve our research capacity and patient care.”
||The SharePoint Server–based portal and data repository will dramatically improve our clinical and drug trials. Our teams will be more efficient, [and] we will have full visibility and control of our data.
Director of Application Support, Atlantic Health
Clinical and drug trials are arduous, multi-faceted efforts that involve a variety of supervisors, administrators, physicians, and participants. In facilitating these trials, Atlantic Health brings together sponsors (pharmaceutical and research companies), primary investigators (the physicians who conduct the research), and subjects (those who participate in the trials), as well as finance, compliance, and internal review entities. Supporting the trials is a bevy of forms—more than 40 in all—used to capture and chart information related to the research, the finances associated with the trials, process administration, and reporting. Historically, the process at Atlantic Health has been manual and the forms supporting it have been entirely paper based.
“Currently, a significant amount of time is spent creating new paperwork, or on the phone trying to track down existing paperwork,” Brodt-Suggs laments. “Trial-related forms are filled out manually and routed to different departments for processing and storage. Each department handles the forms differently, so our data has been lacking continuity and is scattered throughout the organization. We have had very little control over or visibility of our trial information.”
As a result, Atlantic Health’s clinical and drug trial process has been slow and inefficient, and stakeholders spend an inordinate amount of time managing the paperwork that accompanies each trial. It has been difficult to track and report the trial information needed to demonstrate regulatory compliance. And analyzing data and trends across multiple trials to maximize research findings and patient care has been unfeasible.
To streamline research efforts, improve health information management, and ensure compliance, Atlantic Health is digitizing its formerly paper-based clinical and drug trial procedures. With the assistance of Quilogy, a systems integrator and Microsoft® Gold Certified Partner, the healthcare provider established a Web-based portal and centralized data repository that are expected to go live in August 2008. The portal, based on Microsoft Office SharePoint® Server 2007, and repository, based on Microsoft SQL Server® 2005 data management software, provide a common foundation for all of Atlantic Health’s clinical and drug trial procedures and information.
Central to the solution are electronic forms based on the Microsoft Office InfoPath® 2007 information-gathering program. More than 40 paper forms have been converted to electronic format and will be accessed through the portal and stored in the data repository. Eight customized workflow procedures, developed by Quilogy, will guide users through routine processes associated with clinical and drug trials, such as alerts, approval requests, subject enrollment and reimbursement, and the like.
“Once a user has logged on to the portal, a master InfoPath 2007 form guides them to the list of required forms for the currently selected workflow,” says Pawan Jindal, Healthcare Managing Consultant at Quilogy. “The master form is dynamic and leads users through the process. Depending on the user’s access rights, the current workflow, and the fields the user selects, the built-in intelligence automatically shows or hides other fields and information.”
Approved administrators, principal investigators, finance personnel, internal review board members, and compliance specialists all will have access to the portal and be able to fill out, distribute, and store trial-related forms as needed to fulfill their responsibilities. They will, however, be limited to the trials and data with which they are associated, which helps ensure that sensitive health and research information is accessed only by the appropriate people.
|Overview of Atlantic Health Clinical and Drug Trial Process|
With a shared, electronic system that streamlines and facilitates the multifaceted clinical and drug trial process, Atlantic Health is anticipating a 35 percent reduction in time spent on administrative tasks, which will improve research efficiency and capacity. The new solution will also help the healthcare conglomerate ensure regulatory compliance through advanced data management.
Increased Research Efficiency
The new solution is expected to improve the speed and efficiency with which Atlantic Health proposes, prepares, and conducts clinical and drug trials. All authorized stakeholders—from physicians and administrators to finance and compliance personnel—will have easy yet appropriate access to the forms and customized workflows that guide and expedite the trial process.
“Atlantic Health personnel have had difficulty finding forms and were often unwittingly using outdated ones,” says Jindal. “The forms will soon be managed from a central repository, making them easy to access. And users will automatically get the latest version as part of the workflow process.”
The solution not only will improve the productivity of trial administrators, physicians, and other stakeholders, but also is expected to boost Atlantic Health’s research capacity.
“Because we will spend less time creating, handling, and searching for paperwork, our clinical and drug trials will be much more efficient and expeditious,” says Brodt-Suggs. “We anticipate that we will be able to conduct additional trials each year, which will lead to greater research and more sponsorship proceeds.”
Improved Data Management and Compliance
The solution will also help ensure that Atlantic Health’s clinical and drug trials are fully compliant with regulations related to trial documentation. Traditionally, the company’s document creation, transfer, and storage procedures differed not only for each trial, but also for each department involved with the trials. The central data repository of integrated, standardized trial information will increase the company’s ability to meet regulatory requirements.
“We will soon have a single source for creating, sharing, and storing trial-related information, which will improve our data-tracking, management, storage, and reporting capabilities,” Brodt-Suggs says. “And although a wide range of stakeholders will use the solution, they will have access only to the trials and data to which they are authorized.”
With a central repository of research-related data, users involved in Atlantic Health trials will be able to track and monitor program budgets in real time, easily access trial results, and search for trial information using keywords. Also, the company plans to explore the possibility of adding business intelligence capabilities to the solution, which would enable historical trending and data mining across its diverse clinical and drug trials. Analyzing research data more holistically, company leaders believe, will help them to identify unforeseen health trends and improve patient care.
“The SharePoint Server–based portal and data repository will dramatically improve our clinical and drug trials,” Brodt-Suggs concludes. “Our teams will be more efficient, we will have full visibility and control of our data, and we will be able enhance the solution over time to continually improve our research efforts.”
Microsoft Solutions for the Healthcare Industry
Healthcare and life sciences organizations are under tremendous pressure to meet regulatory requirements, improve patient care, and reduce the time it takes to develop drugs and take them to market. To meet this challenge, Microsoft and its partners have developed cost-effective solutions that enable healthcare organizations to streamline and automate daily processes that improve productivity and deliver information whenever and wherever it is needed. The result is enhanced productivity, safety, and quality.
For more information about Microsoft solutions for the healthcare industry, go to:
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