Companies submitting for the Data Driven Award were asked to supply answers to the following four questions:

1. Please provide an overview of the project including the initial sponsor challenge and vendor/partner solution.

Challenge:

Biogen Idec had several very large global studies running across 300 sites, 30 countries, with more than 5,000 patients, utilizing multiple data acquisition technologies and vendors.  Millions of records of data were processed and stored within CDMS, EDC, CTMS, IVR, and Central Laboratory systems.

Biogen was faced with the challenge of evaluating the status of the data for their trials across disparate systems, using multiple service providers.  The magnitude of the challenge was  heightened  by the global nature of the trials.  Missing data was uncertain and accurate projections of time lines and data was  very difficult to evaluate across the global vendor teams.

Solution:

Biogen selected PharmaPros DFM Enterpriseâ≥¢, a cloud computing solution that enables in-house systems to share data over the web. With this, Biogen Idec was able to create an eClinical cloud connecting their clinical systems that relate to data status.

The solution includes PharmaPros' Enterprise Adapter™ serving as an engine for Dataflow Manager, an integrated workflow and reporting technology. With this combination, DFM Enterprise was able to tap into to the operational intelligence stored within Biogen Idec's clinical systems, providing a holistic view of trial progress without the need for custom development or system integration.  With accurate, in-stream access to study progress, metrics, and most importantly, missing data, Biogen was able to manage their global vendors to meet timelines with confidence.

2. Please describe how this project&rsquo's solution adds significant impact on quality and/or efficiency to the clinical data manager's work.

The DFM Enterprise solution enabled Biogen Idec to efficiently manage multiple outsourced service providers in global site monitoring and data management, centered in the US, Central America, Europe and India though automation of detailed work lists and performance metrics that incorporate specific protocol and global complexities surrounding missing, discrepant, and late data for orchestrating teams of hundreds to manage studies all within a few months.

The sharing of these operational data from the various vendor systems and internal Biogen Idec data sources was delivered through one central interface, Dataflow Manager, with one holistic view of the trial data status.  This solution automated the collation of millions of records, thousands of subjects, and hundreds of sites into an interactive, operational dashboard allowing Biogen Idec DMPMs to review and discuss current, in-stream work items to make quick decisions and proactively manage vendors by mitigating potential issues before they occurred.

A specific Biogen Idec example: Biogen Idec saved valuable resource time of their vendors and themselves, through the new ability to accurately evaluate aging and missing data. They used this to help schedule site monitoring and data retrieval by focusing on sites with the largest page flow or greatest latency.  This in turn provided the ability to project resource needs across vendors and in-house teams with the understanding of accurate and expected dataflow. As a result Biogen Idec's DMPMs had the confidence to predict and hit their time lines for database lock across the many vendors and source systems.

3. Please describe how this project represents an innovative application of process and/or technology.

With the implementation of PharmaPros. Enterprise Adapter as part of the DFM Enterprise solution, PharmaPros was able to create a new eClinical technology landscape, or cloud, for Biogen Idec.  They can continue to use their current in-house systems, and also choose new technology or even connect to their vendor’s in-house systems to ensure they have a continuous view of study progress regardless of the technology and where it resides. PharmaPros˙ Enterprise Adapter can connect any existing technology to deliver in-stream operational intelligence across their cloud within weeks.

Without the innovation of the Enterprise Adapter most eClinical systems would remain separate with operational data residing in silos, requiring many man-hours of work to determine the status of a trial.  This is the first technology of it˙s kind in the industry with a focus on enabling a sponsor to create a eClinical cloud of internal and external source data for sharing study metadata, status of clinical data, subject visit schedules and dates, monitoring visits, clinical events, and subject disposition.  Once enabled, Dataflow Manager provides analytics against the actual data and study protocol requirements to drive vendor management, complete data accountability, and open visibility into the complete study status and all this without the need to enter any information.  Everything is driven from the source data/systems.

4. Please describe how the project demonstrates an active collaboration between a service or technology provider and a study sponsor.

PharmaPros worked closely with Biogen Idec to understand their vendor landscape, overall flow of data from various sources and vendors, and study specific data expectations to deliver a scalable, automated solution configured to meet their specific needs.  Business process terminologies, data processing workflow, enterprise-wide study performance metrics, and vendor specific work lists were tailored to meet Biogen Idec˙s specific clinical landscape and trial management best practices.

Delivered as Software as a Service, the DFM Enterprise solution is able to evolve with Biogen Idec as they define and adopt new systems, processes, vendors, and workflows.  The Biogen Idec teams are able to collaborate with PharmaPros' support team on new configurations and process improvements.  Biogen Idec is excited at the prospect that this solution will not become static and out of date as with many installed applications using the traditional software model.  Instead, PharmaPros' DFM Enterprise solution is delivered and supported as an agile, dynamic workflow application that is intended to grow and evolve with the user.

Technical Support is monitored proactively through the software to enable PharmaPros support team to respond to problems in a timely manner.  DFM Enterprise is monitored continuously for performance and errors are sent automatically to the support team.  Biogen Idec and PharmaPros collaborate daily through the software itself: a very new idea in eClinical technology