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    During the design of a BI infrastructure, certain well known steps should be followed:
    • prioritization of business processes, to be monitored v
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    is-?-vis their performance
    • development of a roadmap for a phased implementation (e.g. using the bus architecture matrix in a dimensional infra
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    tructure)
    • business requirements analysis with the SME’s
    • data source & organizational readiness assessment
    • translation of busines
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    requirements into conceptual data modeling
    • definition of analytical applications to be implemented
    • decisions on the sourcing model (i
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    sourced / outsourced)

    Whether the whole endeavor or parts of it, is insourced or outsourced, directly influences the needed internal know-how and sk
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ills and affects the degree of control of the Business. Strategic know how and skills should not be outsourced, since they can evolve to an importan
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    competitive advantage for the Business.

    If all work is left to a consultant-integrator Consortium, the Business runs the risk of loosing control an
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    being led to suboptimal decisions, techniques or infrastructure architectures.

    How many design steps and which distinct design skills are needed be
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ore implementation starts, is not successfully determined by many Businesses. A Consultant who is specializing in datawarehouse design and/or dimensi
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    onal modeling is often not skilled enough to analyse business requirements and identify analytical applications to be implemented (e.g. a data modele
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    is often not knowledgeable on Customer segmentation and/or Customer retention techniques). Therefore he may not be able to identify the information
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    eeded, or the facts to be derived. On the other hand, a database marketing specialist is often unable to evaluate BI infrastructure architectures and
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    data models which are suitable for the analytical applications identified (e.g. how to model a data mart aiming to perform RFM analysis).

    It is clea
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    rly identified by many BI thought leaders that BI professionals need to have both business & IT know-how and skills.

    At the leadership level, the su
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    cess of a business intelligence endeavor often depends on the ability to ‘see the whole picture’. In case of a Customer Intelligence project, combine
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    skills of the project leader, on the identification of the appropriate marketing strategy and the implementation of the latter based on a successful
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    design & implementation, allow him to identify issues early-on and steer the project successfully.

    On the other hand, if we have to decide on the mo
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    st critical success factor, business requirements analysis comes first. A leader with a clear vision on the business goals and the strategy to achiev
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    them, can probably search and find the rest of the skills. Some may argue though, that it’s not possible to identify the full set of business requi
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ements in advance, in a dynamically changing environment. Therefore the design of a flexible & extensible data model, would allow future enhancements


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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