How Small to Medium-Size Business Use EDC

October 16, 2015
Lisa Henderson

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials and Pharm Exec. She can be reached at lhenderson@mmhgroup.com.

Applied Clinical Trials

In our latest webcast that aired live October 14, Oracle Health Sciences brought together three presenters from smaller or medium-size organizations in an effort to educate similar-sized companies on the benefits of EDC.

In our webcast that aired live October 14, Oracle Health Sciences brought together three presenters from smaller or medium-size organizations in an effort to educate similar-sized companies on the benefits of EDC.

Oracle presented that it increasingly hears similar comments from the “SMBs” or small to medium sized businesses it speaks with:

“How can we conduct high-quality and efficient trials without exceeding our budget?”

“How can we increase data quality and integrate and clean data from more sources, without compromising speed or efficiency?”

“How can we ensure trial and data integrity in light of increasing data complexity and volume as well as growing security risks?”

Sounds familiar to the needs of the larger organizations? It does, but we aren’t as familiar to hearing it from the smaller-sized brethren that comprise our clinical trials ecosystem. And the views from those SMBs using Inform EDC were refreshing. (yes, it’s an Oracle product, but it was an Oracle webcast and it wasn’t presented as a sales pitch, really, it was informational). These organizations understand the importance of EDC. Below outlines their specific needs based on their operations.

Marina H. Nillni, PMP, EDC Program Manager, Dana-Farber Cancer Institute, Dana-Farber/Harvard Cancer Center, described its use of InForm since 2005. In 2014, the entire Dana-Farber/Harvard Cancer Center consortium had 923 active trials. However, the segment of Principal Investigator-Initiated studies featured 61 new studies, with 8,843 subjects. Nillni said for those PII studies, that is where InForm is used. She noted the primary drivers for going away from paper were: timely data not available for Data Safety Monitoring; a higher risk of these types of trials due to their complexity and use of innovative therapies; typically high turnover rates among research coordinators; paper process for data cleaning is manual and extremely time consuming; investigators don’t have access to their data for publication in a timely manner, which in turn negatively impacts grant funding.

Jeffrey Nau is Vice President, Clinical and Medical Affairs at Ophthotech Corporation, a biotech focusing on developing novel therapeutics to treat eye diseases. Nau noted that biotech companies may be small, but the decisions to implement technology are based on the return-on-investment and timelines as they relate to investors. For these small biotechs, the decisions rely on what to outsource and what to insource. Also, CTMS is usually not considered an ideal solution for them as the lifespan of the data collected in a CTMS is usually much shorter than what the small biotech deals with.

And Richard Harris, BSE, MSME, IT Manager at Seaview Research presented how its Phase I and early Phase II studies use InForm EDC. Each of its two sites have 160 beds, and based on the features specific to these early studies, Harris said it’s too complex to manage on paper, and to not have the source documents available electronically would be difficult for quality control. Those features are as follows:

  • For each protocol, Seaview makes a schedule of events to follow for each study visit

  • Each study visit typically has 5 or more events

  • Events are usually time sensitive

  • Intensive PK/PD days can have well over 25 events

  • Each event has a source document

  • At Seaview, medical staff make sure events assigned to them are completed and documented in a timely manner

  • Time between one subject’s event and the next is usually between 2 and 5 minutes

The presentations delve into the details of how they use InForm and the benefits that their organizations have received. If you want to learn more, you can watch on-demand for free.

 

 

 

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