Reduction in Approval Time of Clinical Trial Labels Eliminates by sleepnow


									Reduction in Approval Time of Clinical Trial Labels Eliminates
Major Bottleneck in Drug Development Process
PROJECT BACKGROUND                       redesign its global processes
                                         for approving, storing, and
                                                                          •   Educating the packaging
                                                                              facilities on the process
An evaluation of clinical supply         archiving documentation of           required to perform process
packaging cycle time at a major          clinical trial label approval.       redesign and harmonization.
pharmaceutical company
identified the label development     •   A detailed functional            •   Documenting and sharing the
process, specifically the clinical       requirements document                existing label development
supply label approval                    needed to be developed from          processes used by each
component, as the major                  which an application could be        packaging facility.
contributor to overall cycle time        developed from the ground
                                                                          •   Facilitating team workshops
and variability. The company             up.
                                                                              and group exercises for
recognized that in order to                                                   developing a harmonized
meet increasing demands and          Additional challenges facing the         electronic document
aggressive packaging                 project were label development           management process that
deadlines, the label                 activities that occurred across          would meet Part II
development process would            multiple packaging facilities            requirements.
have to be reduced by nearly         around the world and included
80%, and variability in the          third parties and international      •   Determining the ability of the
process brought under control.       project team members that had            company’s current computer
                                     not worked together prior to this        and network infrastructure to
Through the utilization of the       initiative.                              support the proposed
latest computer and web                                                       application.
technology, the company
believed that the variability and
                                     IPM’S SOLUTION                       •   Developing a functional
                                                                              requirements document and
overall time required to approve     Integrated Project Management
                                                                              a request for proposal bid
clinical trial labels could be       Company, Inc. (IPM) developed
                                                                              package to solicit vendors to
significantly reduced. In order      and implemented a strategy to
                                                                              develop the application.
to develop an electronic vehicle     redesign and harmonize the
that would reliably reduce the       label development process.           •   Evaluating vendor bids and
approval process time, several       Subsequently, IPM developed              identifying the most viable
issues needed to be                  a functional requirements                proposals.
considered and addressed:            document from which an
                                                                          •   Developing a strategy to
                                     application could be developed
•   The approval of clinical trial                                            code the application and
                                     to fulfill the company’s ultimate
    labels was required to follow                                             globally implement the new
                                     goal of reducing the overall
    Good Manufacturing                                                        electronic process.
                                     cycle time of their packaging
    Practices; therefore, any        production. Key elements of          •   Ensuring completion of all
    electronic system developed      this solution included the               preparatory work and follow-
    must comply with                 following:                               up through each business
    government regulations,                                                   unit.
    specifically 21 CFR Part 11      •   Promoting a common vision
    (Part 11).                           for the new electronic
                                         approval vehicle and
•   Each clinical supply facility        document management
    needed to harmonize and              system.
PROJECT RESULTS                          vendors to provide not-to-
                                         exceed bids within 15%.
Immediate results recognized
by the company included the          •   Evaluation of vendor
following:                               proposals based on the
                                         company’s requirements of a
•   A high-level process flow            vendor resulted in the
    was developed outlining the          identification of the top three
    current (non-electronic) label       providers of viable solutions.
    development processes used
    by each packaging facility.      •   To provide continuous
    This provided a common               promotion of teamwork,
    baseline and clearly                 communication, and focus to
    identified specific obstacles        project objectives, IPM
    that would have to be                developed communication
    addressed for the electronic         tools to provide a mutual
    process to be successful and         understanding of activities
    minimized the potential of           within the team.
    overlooking an obstacle.
                                     To guide future portions of the
•   Through project review
                                     project, IPM provided the
    meetings, the project team
                                     company with conclusions,
    was able to develop a
                                     recommendations, and a high-
    harmonized electronic
                                     level coding and
    document management
                                     implementation strategy. This
    process that met the needs
                                     information summarized the
    of each packaging site and
                                     project and provided the
    the FDA. This ensured that
                                     company with objective
    the application would be
                                     information upon which to base
    flexible enough to meet
                                     decisions for subsequent
    future business needs and
                                     portions of the project.
    ensure the company would
    be able to maximize the use
    and life of the application.
•   An evaluation of the
    company’s network
    infrastructure coordinated by
    IPM revealed that
    communication lines
    between users could support
    the application and that only
    computer hardware and
    software would have to be
    purchased. This allowed the
    company to estimate the
    infrastructure cost of
    implementing the system and
    determine if adequate funds
    were available.
•   A functional requirements
    document was developed
    and used to solicit bids from
    potential software solution          200 South Frontage Road, Suite 220
    providers. This document             Burr Ridge, IL 60527
    ensured the company’s                T 630.789.8600
    requirements were clearly            F 630.789.7945
    identified and enabled the

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