By Jeff Rogers  

January 5, 2012 | Guest Commentary | In 2011, biopharma sponsors continued to rely on an increasing number of contract research organizations (CROs) and eClinical technology solutions to support the research of drugs and related devices. Biopharma sponsors’ most precious asset: controlled access to clinical data throughout the course of trials, became more crucial and challenging than ever.   

Due to innovative advances in cloud security and data warehousing standardization, the industry saw sponsors—even smaller, mid-market players—moving toward storing, sharing, and accessing data in repositories. The increased pressure from the Food and Drug Administration (FDA) to standardize data collection and submission proved to be in-line with the “self-service” adaptability sponsors prefer for their data. While many technology solutions aimed to serve as a “hub” of clinical data for organized access, other technologies showed a more user friendly, less complex outlook for sponsors. Setting the stage for 2012, CROs are now not only responsible for executing studies and helping analyze and evaluate clinical data, but also offering access to data from all trials in one location.    

Expectations in 2012  

In 2011, the industry recognized the importance of the diverse skills required for clinical development staff to be more technology savvy and adaptable to other functions within the clinical trial process. As a result, in 2012, data managers progressively will develop a broader range of skills requiring highly effective people that are trained to stay on the edge of innovation, while becoming more analytical in their approach to clinical research.   

Experience in the therapeutic category will continue to become more important, especially for CROs serving the smaller and mid-market players. As a result, there will be more specialization in the CRO market and sponsors will become comfortable leveraging a range of CROs to support their pipelines—the one-size-fits-all approach when it comes to clinical development will no longer exist.   

There will be a greater increase in technologies that look to streamline processes to cut down on costs and increase collaboration with strategic partners, academia, community influencers and the individuals directly involved in the trials. New solutions will become more widely accepted such as cloud computing and CDR technology. The estimated cost savings and efficiency gains of trials—due to standardization, higher business intelligence, increased benefits of aggregating data and usability of cloud computing—will majorly impact the industry as a whole.  EDC and CDR technologies are expected to become more “self-service” for the end user, which is more efficient, affordable, and gives the sponsor the ability to leverage their data near real time, all the time.  

Experience with CDISC standards will continue to grow. From 2003 to 2011, global companies took action to become charter sponsors of CDISC, growing their numbers from 32 to nearly 300. The result is a progressive organization that supports the electronic acquisition, exchange, submission and archive of clinical and pre-clinical study data. By creating a working link between EHRs and clinical research systems, called Retrieve Form for Data Capture Profile (RFD), they will continue to enable development of worldwide implementations and overcome the pessimistic view that the EHR and clinical research systems integration is a futuristic thought.   

In 2012, the increased ability and effective demonstrations of the integration between EMRs and EDC will increase, as EMRs mature and are well-utilized enough to analyze patient populations for clinical trial recruitment. EMR-EDC integrations moving from pilot to real world deployment will continue to emerge regionally in the U.S. and especially in Europe, where electronic patient records are already in place due to their national health care programs. Pulling from the enlarged data pool, these programs will enhance the clinical trial process and FDA processes.  

Pharma collaboration with academia also will expand, as they look to build new incubators for early phase development, cultivating closer connections with the best and brightest think tanks and facilities that foster innovation, perform studies, and share intelligence. Bi-directional relationships with academia will leverage knowledge, facilities, students and personnel. In turn, these relationships will stimulate business connections with academia to positively impact college and university costs for future students looking to enter the pharmaceutical space. Via these relationships and through greater connections with social media communities, an increased need for highly effective and qualified people will result in the potential to create more jobs and continued expansion of community influence. For example, Pfizer (creating 450 jobs) and Sanofi are building research centers in Cambridge, Mass.  

With increased partnerships, sharing and co-development will be commonplace and no longer a concern or threat to the clinical trial process. In addition, funding for new start-ups to enter the market will fuel the economy in new ways. In 2010, venture capital-founded and -developed life sciences companies employed more than 1.7 million people in the United States. This only will continue to increase in 2012 as more specialized companies enter the clinical trial market from all angles.   

As the industry continues to see these patterns unfold, there will be a massive impact on not only the way they do business, but on the way their clients do business as well. Technology is playing a larger role in the value of how a company aggregates data to be put in front of the FDA. The return on investment from these patterns will serve to better the clinical trial and FDA processes in 2012 and beyond.  

Jeff Rogers is executive vice president, Business Development & Strategy at eClinical Solutions. He can be reached at jrogers@eclinicalsol.com.