What a great time DIA Boston was!
As Director of Clinical Solutions, one of my responsibilities is giving product demonstrations in BioClinica’s exhibit booth. Much of my time during conference hours was spent with my eyes and ears focused on growing my understanding of your needs to run clinical trials more efficiently and cost-effectively.
Below is a recap of hot topics from my vantage in the exhibit hall point where thousands of industry professionals converged to learn new ways to overcome current and future challenges:
Having recently grown to 16 member companies, TransCelerate is rapidly gaining momentum as the consortium drives toward clinical research change. Two best practice recommendations widely discussed were the use of CDISC SHARE and Risk Based Monitoring. Check out an earlier blog I wrote about semantic standards including SHARE. To see how TranCelerate plans to assess risk in clinical trials, read the position paper here .
Risk, Managing Risk, Risk-Based Monitoring
Risk was a major theme in multiple areas throughout the conference. Two recent FDA draft guidance documents give pharmaceutical companies the go-ahead for managing risk while making the process of collecting and reviewing study data easier and less costly. Several DIA sessions explored compliance with these documents: Electronic Source Data in Clinical Investigations, Nov. 2012 and Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring, Aug. 2011
My colleagues and I demonstrated how BioClinica’s innovative risk management software can provide significant cost-savings. Missed it? Contact us for a private demo.
Here’s a photo of me drilling down into the data using the big touch screen in the Microsoft exhibit.
The Sunshine Act
Many people stopped by and expressed concern about Sunshine Act compliance. Fast-approaching, the Act requires pharmaceutical, medical device, biological, and medical supply manufacturers to report "payment or other transfer of value" to physicians and teaching hospitals. BioClinica’s OnPoint CTMS has a payment module that supports Sunshine Act reporting requirements.
Linda Sullivan of the Metrics Champion Consortium (MCC) popped in to thank BioClinica for its support in developing standardized metrics. She also requested assistance with completing MCC’s own Risk-Based Monitoring Industry Survey. This all-volunteer group has assembled recommended standard metrics for multiple areas including Clinical Trials, Central Labs, Imaging, and Cardiopulmonary. Learn about recent milestones.
Many DIA event-goers used myDIAfun.com to find parties, restaurants, and prize opportunities. Based on considerable positive feedback, BioClinica is pleased to offer MyDiaFun for next year’s convention in San Diego.