Better Health Care Through Big Data by Glen de Vries

“Big Data” is often used to describe new ways to look at information to create better outcomes. For example, using “Big Data” to better understand how patients are responding to new therapies, or to detect safety signals in large post-approval patient populations. However using large scale data inputs and analyses can also lead to better day-to-day processes. That may initially sound a lot less sexy, but actually, when you think about how basic processes and procedures in healthcare and life sciences affect real world outcomes at tremendous scales, thinking about using Big Data as a process improvement tool becomes incredibly exciting. This is exactly how we look at some of Medidata’s Insights offerings, and Dr. Harlan Krumholz gave an amazing example about how this approach affected hospital operations during a Big Data panel at last year’s Forbes Healthcare Conference.

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From WordPerfect and Lotus 1-2-3 to the Clinical Cloud Tipping Point by David McNierney

Do you remember WordPerfect and Lotus 1-2-3? If so, you’ll understand the Clinical Cloud tipping point.

Professionals of a certain age will fondly remember using desktop applications like WordPerfect word processing, Lotus 1-2-3 spreadsheets, Harvard Graphics presentations and Ashton Tate’s dBase III database. Each was a best-in-class tool that delivered fantastic productivity improvements.

Yet, in what seemed like overnight, we were all using Microsoft Office for the same business needs. Word, Excel, PowerPoint and Access each eclipsed their counterparts leaving those vendors precariously close to extinction. But why? (more…)

To Risk-Based Monitor or Not to Risk-Based Monitor by Jeffrey Handen

Clinical site monitoring accounts for up to 30 percent of the total cost of a trial. Ensuring data integrity and patient safety and privacy has traditionally been interpreted by the industry as requiring 100 percent source document verification (SDV) and on-site-monitoring every four to six weeks. However, the FDA’s recent 2011 guidance suggesting alternate approaches to monitoring, combined with increasing evidence of the inefficiency and less than optimal accuracy of 100 percent SDV—not to mention the extremely low rates of data correction due to monitoring—has led to renewed interest in so-called risk-based approaches to clinical monitoring.

The vast majority of commercial trials also rely on 100 percent or near 100 percent SDV. Yet 100 percent SDV has been shown to be only 85 percent accurate and the cost of a 100 percent SDV approach for a typical Phase III program accounts for approximately 25 percent of the total cost of that program (or about $90 million per Phase III program). (more…)

Through the Eyes of Clinical Supplies by David McNierney

In clinical trials, is there any task more important than ensuring the right treatment gets to the right subject at the right time? Achieving this weighty objective is typically a massive undertaking requiring dedicated professionals who understand the myriad roadblocks that can prevent that desired outcome. Challenges have compounded as studies have simultaneously increased their geographical coverage, grown in complexity and taken budget cuts. Regulatory change, disasters (natural and man-made), labor unrest and so forth all stand in the way of timely treatments.

The Global Clinical Supplies Group (GCSG) is a non-profit association that ensures clinical supplies professionals are equipped with the knowledge they need to succeed with this daunting task. (more…)

“When in Rome…” eRA2013: Conferenza di Regolatore Affare e Farmacovigilanza by Sean Neal

The eRA (electronic Regulatory Affairs) 2013 conference was presented by Medidata Technology Partner EXTEDO in Rome, Italy and turned out to be a very exciting event. Not only was it amazing to see the “Eternal City” and walk through locations like the Colosseum, the Roman Forum and other areas that are thousands of years old, it was also amazing to be exposed to an area of life sciences that isn’t always highlighted in the clinical trials world.

Regulatory affairs professionals are the ones that ensure companies comply with the regulations and laws pertaining to the clinical trial process, as well as the final agency approvals to market a drug or device. (more…)

Has Regulatory Guidance on Risk-Based Monitoring Driven Adoption Yet? by Stephen Young

Over the past year and a half we’ve been monitoring the trend towards adoption of risk-based monitoring across the industry, with particular interest in evidence of broader adoption following the FDA draft guidance and EMA reflection paper, both issued in 2011. Given the clear endorsements for this paradigm reflected in these documents, we are anticipating an inflection point towards broader adoption.

So recently we decided to take a look at source document verification (SDV) coverage across the industry from 2008 through 2012. SDV coverage specifically measures the percentage of site-entered eCRF data that is targeted for SDV, which includes both the data already SDV’ed and any additional data requiring SDV. (more…)

Medidata in the Clouds: Using AWS for High Availability by Isaac Wong

Protecting our clients and their patients is the number one priority at Medidata. In the case of randomization and unblinding, this is a matter of life and death. On Thursday, April 18, I will be giving a talk at the AWS Summit 2013 in New York City. This year’s theme is “Navigating the Cloud” and my presentation, Understanding Database Options, will cover how AWS (Amazon Web Services) and RDS (Relational Database Service)—in combination with our private data center—help Medidata protect our customers and their patients. One key to designing a highly available service is redundancy. A service, or database, is redundant if we have multiple copies of it spread around so that when one fails we can use a spare copy in its place. (more…)

“This Is How We’ve Always Done It” – A Phrase of the Past in Pharma? by Ricky Lakhani

We were at the Intrepid Sea, Air and Space Museum last month for the Americas Medidata User Group (A-MUG) conference cocktail and dinner reception. As I ambled along the flight deck of the USS Intrepid, amazed by the variety of aircraft all lined up against the backdrop of Manhattan, it made me think about how each has played a significant role in shaping its industry to what we see in the modern day. (more…)

Predicting the Future of Clinical Site Monitoring: Will We Move Towards a Risk-Based Approach? by Geeks Talk Clinical

Medidata and INC Research co-hosted two seminars in California last week, featuring speakers from both companies as well as Halloran Consulting Group president Laurie Halloran. Following the seminars, Medidata’s John Vlachos spoke with colleagues Fran Nolan, vice president of quality and regulatory affairs, and Stephen Young, senior product director, about the future of clinical site monitoring and how the industry is rapidly moving towards implementing a risk-based approach. (more…)

What a Year Brings: Revisiting the Industry with ICON at AMUG by Geeks Talk Clinical

The eighth annual Americas Medidata User Group (A-MUG) conference took place this March in NYC and welcomed 325 attendees from 103 organizations. At last year’s conference in Philadelphia we had the opportunity to speak with first-time A-MUG attendee Christopher Tyers, clinical data coordinator at ICON Clinical Research. Medidata’s Claribel Pichardo caught up with Christopher again this year to see what he’s been up to since Philly and get his top highlights from this year’s event. Christopher came back to A-MUG as a presenter, sharing how to adopt a real-time paperless approach to study development and roll that out from a contract research organization (CRO) perspective.

Are More Complex Protocols Hurting Enrollment? by Stephen Young

Protocol complexity is a measure of the relative effort needed to conduct a study—specifically, the number and complexity of procedures that investigative sites are required to administer to study subjects. As you might expect, a more complex protocol requires bigger budgets to support the protocol procedures from a regulatory, scientific and operational standpoint. We have also anticipated that since increased complexity puts greater burden on both site personnel and patients, it likely has a negative impact on subject recruitment efforts. (more…)

FiercePharma Webinar Recap: The Future of Mobile in Clinical Trials by Glen de Vries

Hundreds of life science professionals dialed in to hear yesterday’s FiercePharma webinar session, “Drugmakers go mobile,” moderated by executive editor Ryan McBride. Medidata Solutions president Glen de Vries presented—along with industry experts from Genentech, Dotmatics and Kony Solutions—on how pharma companies are embracing digital health and the use of mobile to reach people in a whole new way. Glen spoke about the opportunities for clinical trial development and innovation in mobile and how it can impact those involved, including life scientists, healthcare professionals, subjects and patients. (more…)