04 June 2012

CSC: Too Late, He Cried: EVMPD Tools Now Need to Look to the Future - By Written by John Farrell, Principal Consultant, CSC Life Sciences

With just weeks to go before the EVMPD becomes mandatory, there is much talk about newly emerging software tools to support the XEVMPD messaging format.

The reality is any solution appearing now is too late. The point at which software tools to support the initial data take-on of the XEVMPD messaging would have really needed to be available to industry was early April. Realistically, most pharma companies require a minimum of three months to fully deploy and qualify a novel computer system. Somewhat unhelpfully, EMA were continuing to publish documents that altered the perceived requirements even after that date but "such is life".

In considering these new XML generation/upload and/or Gateway tools, many of which are designed to simply address the maintenance needs of the current XEVMPD requirements, it is questionable whether, on balance, it is good advice to industry to deploy such tools.

For small to medium pharma companies, which may have hundreds or even low thousands of XEVMPD records, the need for a specific software tool to address XEVMPD communications has always been questionable, especially once the initial bow wave of activity has been addressed, since the level of maintenance activity for these companies is likely to only be in the tens/low hundreds per annum.

To find more information please use the below mentioned weblink 

http://www.csc.com/health_services/blog/74101/84578-too_late_he_cried_evmpd_tools_now_need_to_look_to_the_future

6 comments:

  1. I share John’s view but I also believe that currently emerging tools, which provide support only for XEVMPD submissions, are not just too late but also not enough. Any company that recognized this as a key point in choosing their path to July 2nd deadline and beyond made a huge step forward.

    But how many companies were actually aware of this? Unfortunately, our experience has shown not many companies had time to take that into consideration. What were the main reasons?
    They tackled (with hesitation) only this one challenge because of rapidly approaching deadline, constant changes of requirements and lack of resources. There was also noticeable lack of guidance, not only from EMA but especially from vendors that offered XEVMPD submissions tools that are not looking into the future and are not ready to support upcoming ISO IDMP standards.

    As a consequence, a market for XEVMPD services was created. However, considering the impact of the upcoming ISO IDMP standards, we at INFOTEHNA believe that XEVMPD outsourcing is just a temporary solution during the transition process toward the IDMP standards.
    At least for larger organizations.

    ReplyDelete
  2. I share John’s view but I also believe that currently emerging tools, which provide support only for XEVMPD submissions, are not just too late but also not enough. Any company that recognized this as a key point in choosing their path to July 2nd deadline and beyond made a huge step forward.

    But how many companies were actually aware of this? Unfortunately, our experience has shown not many companies had time to take that into consideration. What were the main reasons?
    They tackled (with hesitation) only this one challenge because of rapidly approaching deadline, constant changes of requirements and lack of resources. There was also noticeable lack of guidance, not only from EMA but especially from vendors that offered XEVMPD submissions tools that are not looking into the future and are not ready to support upcoming ISO IDMP standards.

    As a consequence, a market for XEVMPD services was created.
    However, considering the impact of the upcoming ISO IDMP standards, we at INFOTEHNA believe that XEVMPD outsourcing is just a temporary solution during the transition process toward the IDMP standards.
    At least for larger organizations.

    Sinisa Belina,
    Head Consultant - INFOTEHNA Life Science

    ReplyDelete
  3. I share John’s view but I also believe that currently emerging tools, which provide support only for XEVMPD submissions, are not just too late but also not enough. Any company that recognized this as a key point in choosing their path to July 2nd deadline and beyond made a huge step forward.

    But how many companies were actually aware of this? Unfortunately, our experience has shown not many companies had time to take that into consideration. What were the main reasons?
    They tackled (with hesitation) only this one challenge because of rapidly approaching deadline, constant changes of requirements and lack of resources. There was also noticeable lack of guidance, not only from EMA but especially from vendors that offered XEVMPD submissions tools that are not looking into the future and are not ready to support upcoming ISO IDMP standards.

    As a consequence, a market for XEVMPD services was created. However, considering the impact of the upcoming ISO IDMP standards, we at INFOTEHNA believe that XEVMPD outsourcing is just a temporary solution during the transition process toward the IDMP standards.
    At least for larger organizations.

    Sinisa Belina,
    Head Consultant - INFOTEHNA Life Science

    ReplyDelete
  4. I share John’s view but I also believe that currently emerging tools, which provide support only for XEVMPD submissions, are not just too late but also not enough.
    Any company that recognized this as a key point in choosing their path to July 2nd deadline and beyond made a huge step forward.

    But how many companies were actually aware of this? Unfortunately, our experience has shown not many companies had time to take that into consideration. What were the main reasons?
    They tackled (with hesitation) only this one challenge because of rapidly approaching deadline, constant changes of requirements and lack of resources. There was also noticeable lack of guidance, not only from EMA but especially from vendors that offered XEVMPD submissions tools that are not looking into the future and are not ready to support upcoming ISO IDMP standards.

    As a consequence, a market for XEVMPD services was created.
    However, considering the impact of the upcoming ISO IDMP standards, we at INFOTEHNA believe that XEVMPD outsourcing is just a temporary solution during the transition process toward the IDMP standards.
    At least for larger organizations.

    ReplyDelete
  5. I share John’s view but I also believe that currently emerging tools, which provide support only for XEVMPD submissions, are not just too late but also not enough.
    Any company that recognized this as a key point in choosing their path to July 2nd deadline and beyond made a huge step forward.

    Sinisa Belina, Head Consultant - INFOTEHNA Life Science

    But how many companies were actually aware of this? Unfortunately, our experience has shown not many companies had time to take that into consideration. What were the main reasons?
    They tackled (with hesitation) only this one challenge because of rapidly approaching deadline, constant changes of requirements and lack of resources. There was also noticeable lack of guidance, not only from EMA but especially from vendors that offered XEVMPD submissions tools that are not looking into the future and are not ready to support upcoming ISO IDMP standards.

    As a consequence, a market for XEVMPD services was created.
    However, considering the impact of the upcoming ISO IDMP standards, we at INFOTEHNA believe that XEVMPD outsourcing is just a temporary solution during the transition process toward the IDMP standards.
    At least for larger organizations.

    ReplyDelete
  6. I share John’s view but I also believe that currently emerging tools, which provide support only for XEVMPD submissions, are not just too late but also not enough.
    Any company that recognized this as a key point in choosing their path to July 2nd deadline and beyond made a huge step forward.

    But how many companies were actually aware of this? Unfortunately, our experience has shown not many companies had time to take that into consideration. What were the main reasons?
    They tackled (with hesitation) only this one challenge because of rapidly approaching deadline, constant changes of requirements and lack of resources. There was also noticeable lack of guidance, not only from EMA but especially from vendors that offered XEVMPD submissions tools that are not looking into the future and are not ready to support upcoming ISO IDMP standards.

    As a consequence, a market for XEVMPD services was created.
    However, considering the impact of the upcoming ISO IDMP standards, we at INFOTEHNA believe that XEVMPD outsourcing is just a temporary solution during the transition process toward the IDMP standards.
    At least for larger organizations.


    Sinisa Belina,
    Head Consultant, INFOTEHNA Life Science

    ReplyDelete