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The research and development process continues to be long, complex and costly. Sponsors are challenged with filling pipelines, conducting complex global clinical trials and complying with requirements for additional safety and efficacy data.

The Omnibus Final Rule (Final Rule) entitled "Modifications of the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the HITECH Act" became effective on March 26, 2013.

The process of bringing a new molecular entity or device to market has historically been long, costly and both paper and people intensive.

Clinical research is complicated, and it?s not just the science. Take CDASH, CDISC and E2B for example. Aren?t acronyms awesome?

The excessive cost of clinical trials mixed with the inefficiency of clinical trial management is a widespread problem among research institutions.

Although both the US Food and Drug Administration and the European Medicines Agency provided guidance on predictive analytics techniques in the development of a risk-based approach to the monitoring of clinical trials as far back as 2011, pharmaceutical and life science companies have been slow to fully adopt this approach across their study portfolios.

This study is grounded on the idea that in order to improve study startup performance, you must first be able to identify those key drivers of performance.

The clinical trial industry often believes that the costs of supplying drugs to clinical trials are a less significant contributor to the overall costs of running clinical trials.

On January 23, 2013, the Department of Health and Humans Services (HHS) published the Omnibus Final Rule (Final Rule) as a modification to the "HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the HITECH Act and the Genetic Information Nondiscrimination Act of 2008."

With all of the talk and emphasis on data and using technology and tools to determine better monitoring strategies, the other component becomes operational. What will companies do internally to manage a monitoring shift?

Courtney McBean, president and co-founder of Blueprint Clinical, explained in Part 1 about what made her decide to start up a technology company that specifically addresses risk-based monitoring (RBM).

There are significant challenges facing the pharmaceutical and contract research organization (CRO) industries in relation to patient recruitment of clinical trials and the need to implement new strategies to finally overcome what has been called ‘the most difficult and challenging aspect of clinical trials.’

Pharmaceutical companies are paying more attention to value than ever before.

As the attention on risk-based monitoring continues, more companies and sponsors are revealing their past and present strategies to address or improve this area of clinical trials.

Source data verification (SDV) remains a concept that many sponsors, CROs and sites take to heart.

Gamification is the application of game elements and game design techniques to non-game problems.

When the EMA and the FDA both released their views on risk-based approaches to clinical trials in August 2011, a light appeared for sponsors looking for relief in the way they manage resources in clinical trials.

Sponsors, CROs, regulators, sites and opinion leaders have discussed the pros and cons of a risk-based approach to field monitoring for years. The pharmaceutical industry always sought guidance from the FDA, and different approaches for reviewing data collected by sites.