The need to make late-stage clinical trials more manageable and less costly, coupled with data security needs have driven about 28 percent of the life science industry to adopt cloud-based solutions, according to an upcoming report from NextDocs. It’s based on a survey of C-level executives at 150 life science industry companies.
The technology company develops SaaS tools for pharma and life science companies.
Nearly half of respondents (46 percent) said they had switched over to electronic Trial Master File management tools, according to the report. Although the shift has occurred in the past three years, adoption accelerated this year.
“When CROs and life sciences companies operate on the same platform, it greatly enhances collaboration and eases the management and compliance burden,” said Matt Walz, chief strategy officer and co-founder of NextDocs. CROs used to be “technology laggards,” but as their collaboration with pharma has increased, they are leading technology adoption and innovation in the life science industry, according to the report.
Half of the life science industry is still largely managing essential documents manually, according to the report. About one-third of respondents continue to rely on paper-based, manual systems. Another 20 percent use a hybrid system.
In an interview earlier this year, NextDocs CEO and co-founder Zikria Syed said closer collaboration between pharmaceutical companies and contract research organizations as a way to reduce research and development costs has created its own set of needs. A late-stage clinical trial may generate hundreds of documents from multiple sites around the world. Standardized documentation is critical to ensure that the correct data is included. But using the cloud to distribute those documents makes them easier to find. It also raises awareness of the status of clinical trial documents, improves the process for global teams to contribute trial documents and makes it easier to confirm the data is valid.
Another factor driving the push to the cloud is regulatory compliance. The U.S. Food and Drug Administration requires investigators to keep records for at least six years, in case it does an audit.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The need for leaner, more efficient systems is driven by the need to rein in expenses. Industry growth has slackened in 2013 to 4 percent from 7 percent eight years ago. Among the causes are patient population changes, increasing regulation and patent expirations, the report noted.
Although its primary focus has been with large pharmaceutical companies, NextDocs began rolling out cloud-based tools to biotechnology companies earlier this year to help them automate on a smaller scale and become leaner.
