Silicon Valley BioTalks

Paper Trials vs. EDC Solutions

Benefits, Challenges, and Best Practices

 

February 25th, 2015 - 5:30-7:30pm (PST)

Hewlett Packard (HP), Palo Alto

 

Sponsored by:

 

 

 

What to consider when deciding to use paper or an Electronic Data Capture (EDC) solution to run a clinical trial? 

How do you choose the EDC system best suited to you? What are the industry trends changing the landscape?

What are the best practices to implement a successful transition from paper to EDC or a full EDC implementation? 

Abstract


Since its beginnings in the 1990’s, Electronic Data Capture (EDC) solutions have been well adopted and the advantages of EDC are recognized throughout the industry. However, according to Applied Clinical Trials, the leading clinical trials online source, only half of all new FDA-regulated clinical trials are captured using EDC, leaving 50% of the market relying on paper. Non-FDA trials increase the percentage of using paper-based clinical trials to nearly 80%.

In paper-based clinical trials, data entry is a time consuming and error-prone process, clinical data can be manipulated or altered, and monitoring remains a cumbersome process. The printing and logistics of paper forms also present hidden time and cost burdens that increase with study size. As an example, Novartis reported a cost of $17 million by needing to print CRFs on NCR paper for 400 clinical trials. Other challenges include data quality, data readability for analysis, and regulatory compliance.

On the other hand, the benefits of EDC solutions are well known across the board, including improved data quality, faster data entry, and an overall 30% reduction in clinical development duration. In a case study led by Applied Clinical Trials comparing a paper query management system with an EDC solution using edit checks, a 65% reduction in the number of queries was detected. Single data entry, remote monitoring, and reduction in the number of queries each save a considerable amount of time. In addition, with EDC software, forms are safely stored and backed-up in a cloud-hosted system allowing users to remotely access a fully searchable central location from anywhere. EDC adoption also leads to fewer site visits, shorter patient recruitment time, reduction or elimination of printing cost and faster data entry resulting in significant reduction in cost.

Despite the tangible benefits of Electronic Data Capture, the adoption of EDC has remained to a surprising 50% due to the complexity and time of EDC implementation. The upfront cost of EDC is also a major deterrent to its adoption, especially for preclinical, non-drug or Phase I trials with lower budgets. Switching from paper to EDC also implies structural changes – It alters the way study and forms used to be designed, changes the skillset needed to run clinical trials, and requires a learning curve to the new technology. In recent years several technologies have been developed that address these challenges. Latest solutions empower users by offering a combination of low cost, ease of use and fast adoption. Our panelists will share their experience with both paper-based and electronics clinical trials, they will discuss benefits and challenges of each, and share best practices for a successful implementation. 

 

Panelists 


 

 

 

Esmeralda Sanjust

Sr. Director of Clinical Affairs at Elixir Medical 
 
Ms. Sanjust serves as the Sr. Director of Clinical Affairs at Elixir Medical, a leading provider of innovative drug-device treatment solutions to patients worldwide. A medical device industry veteran with experience in product development, clinical strategies implementations, regulatory approvals, clinical marketing and market development, Ms. Sansjust has a proven background in analyzing problems and proposing optimal solutions, fulfilling customer needs and meeting corporate goals. 
 
 
 

 

 

Ana Pulido Ferrer

CEO at Digitaliza TXT
 
Ana Pulido Ferrer serves as a Founder and CEO of Digitaliza TXT, a leading technology provider for CROs in Latin America. With over 20 years of experience in IT solutions for clinical research companies, Ms. Ferrer specializes in networking, consulting, training, development and business analysis and strategies. She founded enLinea.la and NaatSolutions, and also co-founded iLibris.
 
 

 

 


 

 

 

Victor Chen

Director Clinical Affairs at Align Technology
 
With over 20 years of experience, Mr. Chen is an innovative clinical and regulatory affairs executive providing expertise in revamping and revitalizing clinical programs. He has a proven success in design and execution of investigational Device Exemptions (IDEs) used for 510(k) and Pre-market Application (PMA) approvals, as well as post-market clinical studies. Mr. Chen has an extensive experience in developing and executing studies in radiation oncology, neurosurgery, electrophysiology, cardiology, pulmonology, general surgery, urology, and gynecology.
 
 
 

 

 

 


 

 

Marc Desgrousilliers (Moderator)

Chief Technology Officer at Clinovo
 
Marc Desgrousilliers joined Clinovo in 2010, bringing with him over 20 years experience in software and engineering, and a passion for developing the right system for each customer. His technical IT expertise includes developing patented technologies in storage and network management.

Marc has worked with both startups and large international companies throughout the Silicon Valley, including VERITAS where Marc ran a large worldwide engineering organization, and Microsoft where he led the development of most of the network management services on Windows. At Clinovo, Marc is responsible for evaluating emerging technologies suitable for the biotech industry, developing the corporate information technology, ensuring industry regulatory compliance and developing clinical systems and infrastructure for sponsors.
 

Silicon Valley BioTalks

 

Silicon Valley BioTalks is the premier event for pharmaceutical and medical device professionals to build their knowledge and expertise. Since its launch, the Silicon Valley BioTalks has gathered over 700 clinical trials professionals from the Bay Area and beyond. The panel has featured over 30 clinical trials industry experts from leading life science companies including Roche, Abbott, Onyx Pharmaceuticals, and Johnson & Johnson.

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"A truly informative panel discussion" "A great forum to hear some
very experienced clinical trial professionals"
"It attracted participants from
all over the Bay Area, and beyond"