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November 17, 2017

A Recap of the New York Medidata NEXT Event: Where Science Meets Technology Meets the Future

 

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Kathleen Boruchowski, Associate Director of Data Management, attended the Medidata NEXTconference in New York City on November 8-10. The conference, which has many global locations throughout the year, offered Medidata’s customers a front row seat to learn how data, insights, and technology are transforming the clinical trials industry and ultimately accelerating the hope for patients desperately seeking new treatment options.

Set at the historic Spring Studios in lower Manhattan, the conference highlighted the impressive capabilities of each of Medidata’s clinical trial technology solutions– most notably RaveX, their newest Electronic Data Capture (EDC) offering which Veristat will be rolling out  in early 2018. Lively discussions and panels surrounding “patient-centricity” demonstrated the efficiencies gained when using clinical systems that are integrated, therefore supporting smarter and faster clinical trials.

 

Medidata NEXT-  Day 1 Highlights:

Day 1 kicked off with sessions focusing on improving existing or new products, including Medidata Safety Gateway and Medical Coder tools. Hearing current customers share thier successes and areas for development of these tools allowed me the unique ability to assess the value in bringing these modules to Veristat customers someday as part of a larger, multi-product, fully-integrated platform.  Among these highlighted integrations was the power of Medidata CTMS, an existing Veristat offering, and RaveX, a new EDC offering for our Data Management team.

It was also quite interesting to hear another Clinical Research Organization’s (CRO) experience in building global libraries of case report forms (CRFs) and programs to support SDTM compliance, as well as a different CRO’s experiences in managing rare-disease programs.  Both topics resonated for me, knowing that Veristat currently works heavily in rare-disease clinical trials and regulatory submissions.    Comparing our strategies to our peers reaffirmed that we (Veristat) have been thoughtful and successful in our approach to both of these challenges as well.

The first day concluded with a keynote speech by a patient advocate, TJ Sharpe. TJ spoke about his own experiences battling melanoma, and the struggles he faced finding and enrolling in a clinical trial.  There wasn’t a dry eye in the building, and everyone in attendance left the day fully committed to improving access and efficiencies of future clinical trials.

 

Medidata NEXT - Day 2 Highlights:

Glen de Vries, President of Medidata opened the day with a comprehensive presentation detailing the roadmap of Medidata’s products.  Most striking were the new tools for Synthetic Control Arms, eliminating the need for traditional control arms by accessing Medidata’s expansive database of patient data in lieu of collecting new control data, and the Centralized Statistical Analysis tool, an analytics tool which would significantly reduce the need for source document verification by identifying data outliers through machine-learning technology. Other notable roll outs included their Clinical Trial Genomics tool and their Operational Performance Analytics tool (OPAL).

Dr. Raymond Schinazi gave a moving talk, detailing his success in curing Hepatitis C – the first time in human history we have the power to eradicate a viral disease by combating it directly, rather than just preventing transmission. The day concluded with a party at TAO Downtown and a chance to connect with peers and Veristat customers to share our experiences and plans moving forward with Medidata.

The Future?

It was an exhausting couple of days that reinvigorated and renewed my excitement and commitment around delivering data management operational excellence to the clinical trials that my team supports.  I am looking forward to rolling out Medidata’s RaveX so that Veristat can continue to deliver smarter, faster and more patient-centric clinical trials and regulatory submission support to our clients.

 

Boruchowski-123.pngAbout the Author:   

Kathleen Boruchowski
Associate Director of Data Management, Veristat

 Kathleen has been with Veristat for over 3 years and currently leads the day to day operations of the data management team.   She works closely with clients and our technology vendors to determine the most effective and efficient technologies to implement for each unique clinical trial. 

 


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