Report points to time-saving and security benefits
ClinicalLeader.com reported in a November 2015 article that the transformation of clinical research from a paper-driven model into a digital one goes “well beyond the electronic transcribing of data.”
“Wearables [such as the popular FitBit] and smartphone technology now make it possible to electronically collect data directly from clinical research trial participants, skipping many manual and middle steps,” added the website.
Even with high speed computers and software applications that replace paper-based work, though, clinical trials remain costly and time-consuming.
According to ClinicalLeader.com, the cutting-edge trend for reducing these costs and time is a holistic clinical trial management system in the “cloud.” Broadly defined, cloud computing is the centralized management of data and applications on virtual or Internet-based servers. When offered by a third party vendor, they are referred to as cloud managed services.
Some of the benefits of cloud managed services in clinical trials include:
- A centralized “console” for the initial concept evaluation phase, where researchers rely on expert and peer feedback
- Centralized collaboration during protocol development. Keeping the latest document with all the most recent amendments in one central location can circumvent confusion in keeping track of the latest version
- Using a managed services provider to aggregate this data into a central repository can shave months off a clinical trial’s duration
- Top-tier cloud data vendors offer “analytics-as-a-service” This can include data standardization, presentation and visualization services that help pharma companies, clinical research organizations and other partner organizations integrate, share, and analyze data from clinical trials
- Centralizing data in the cloud facilitates nimble and quick action with robust auditing
- A centralized cloud, located in a secure data center, can apply multiple layers of security to sensitive patient data
ClinicalLeader.com describes rising security concerns: “Data theft is on the rise at hospitals, commercial insurers and other healthcare organizations. Pharma companies and clinical research organizations will increasingly find a similar target on their backs as they take on responsibility for more patient data. A top tier provider offers a comprehensive portfolio of managed security services, along with access to experienced IT security experts, including a Chief Privacy Officer who is deeply familiar with the HIPAA Security and Privacy Rule, FDA requirements and other mandates.”
Pharma companies must have backup and disaster recovery to protect clinical trial data that would be difficult—more likely, impossible—to acquire again in the event of data sabotage or a natural disaster. If quick and responsive are the characteristics of tomorrow’s winning pharma company, a similar data management strategy must be deployed. Real-time replication services should be on the “must” list when choosing services from a cloud data vendor’s portfolio
“Nearly every benefit the cloud brings to pre-market trials can also be applied to post-approval studies. Here, the scalability of cloud data management can quickly accommodate drug testing on new groups and larger populations. With the right cloud managed services partner, pharmaceutical companies and the businesses that serve them will be among the first to enter—and succeed—in this promising new landscape for clinical trials,” according to the article.