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Either solutions have their place in helping the clinical research data that is spread across various data marts like CTMS, IWRS, EDC, ePRO, Clabs,... etc. to be brought together through simple methods of extracting data from each of these marts to create a single source of truth dashboards. The dashboards can be tailored to the requirements of each of the levels of the organization so that the same data is used for all levels of dash-boarding but display of what is relevant to each level is available for them to make their decisions faster and uniformly.
PiCRC has certified Business Analytics experts that can help your organization to find quicker and simpler solutions to be able to use a Risk-based Methodology across all the functions of project management and across projects. This methodology is now a requirement from late Nov 2016 with the ICH E6 (R2) being adopted for implementation across the world. This will mean each of the organization needs to be able to demonstrate to the regulatory authorities the steps that they took to identify, mitigate and solve risks and how they were being tracked.
The older thought process of hiding findings within sponsors/CROs is a bygone era and the regulatory agencies are now looking to get more transparency into the data handling, processing and reporting at all levels and does not matter if it was one department or the other that exposed the project to risk. Hence, this is a collaborative approach which the regulatory agency is looking to see implemented by the sponsor/CRO to demonstrate that the project risks were managed in time and appropriately.
PiCRC has experience using specific adaptations of tools like the Tibco Spotfire (for dashboards), MCC tools for risk rating and Transcelerate risk tool for automation and also various other vendor tools that are ready-off-the-shelf kinds too. We can help navigate the implementation in both the scenarios and making the journey for your organizational change more pleasurable and eventually profitable for the organization in terms of project deliverables. Be it the Investigator site, Vendor, Sponsor or the CRO, the "Once source of truth" will be the prevailing principle behind all the dashboards.
With BIG DATA becoming important, unstructured, voluminous and variety of data can be now analyzed with adaptation of various tools available either as off-the-shelf tailored solutions or piecemeal, open-source tools that are easy to configure and simpler to manage.
Data Science and business analytics play an important role in today't technologically advanced ways of collection of data. Though the past decades saw a slew of platforms that did not communicate or merge with each other, today, it is important that all data on each project is available at the finger tips as much, to let the project managers and his teams on the ground see and hear the same story. This is known as the "One source of Truth", thus reducing the subjectivity as well as the interpretative gaps that are created at every level of the organizational hierarchy.
PiCRC has experience using specific adaptations of tools like the Tibco Spotfire (for dashboarding), MCC tools for risk rating and Transcelerate risk tool for automation and also various other vendor tools that are ready-off-the-shelf kinds too. We can help navigate the implementation in both the scenarios and making the journey for your organizational change more pleasurable and eventually profitable for the organization in terms of project deliverables.
Image acknowledgements : To the Originators , see Google Images
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