Hello SCDM friends,
This is my last letter from the Secretary of the SCDM Board of Trustees as I step aside to welcome Dr. Deepak Kallubundi into the SCDM Secretary role. My three years on the board have flown by, yet when I look back, I am proud to see how much we have grown as an organization.
We have embraced the data sciences, as it makes sense for us to have science backed research backing up our role. Our role is becoming much more than clinical data review, as we are now required to have highly technical skills to blend data sources such as data from a variety of labs, vendors, medical records and imaging centers. We now work with larger amounts of data such as data from sensors and devices. I believe our updated GCDMP chapters using the science-based methodology and our new SCDM Scientific Journal will change our industry by naming, defining and giving detail to the new processes we are using today.
We have seen the future of Artificial Intelligence (AI) and Machine Learning (ML) and it is exciting! We see these case studies presented more frequently and we are hearing if not experiencing real-life uses for these technologies. Using AI and ML is not just a what-if anymore, it is here and it is powerful.
We have seen the regulatory agencies around the world that embrace and support the work that SCDM is doing. SCDM has more participation in Europe, India, China, Japan, South America, Africa, Australia and North America than ever before. We are seeing conferences or workshops in many of these locations; we are planning webinars to meet the variety of time zones that we support. we are a worldwide community that includes many aspects within the umbrella of Data Management.
Mostly we have seen a change in the roles of the study team. Site Monitors have more technology at their disposal to be able to review information remotely which should cut down on site visits. Data Managers have more analytic tools to aid with data review. We use a risk-based quality approach to help us focus on the data that really matters. Statisticians are getting standardized datasets that allow them to have repeatable quality and analysis tools all of which results in higher quality output to the FDA.
One thing that has not changed is the dedication and drive of the data management community. This community is passionate about the safety and efficacy of treatments available for our loved ones. I am proud to be part of this community and will continue to support SCDM.
SCDM Secretary of the Board