Clinical research, trial management and its implementation can be complex, time-consuming and costly. For many years clinical trials have been running in the same old way using handwritten forms, in person check-ups, and on premise solutions. Nowadays, clinical trials are often done on a global level, and may even be multi-site studies that last for years. When trials are large and complex, a huge amount of data is generated that needs to be collected, monitored, controlled, analyzed and shared among others in the healthcare industry. As providers of data entry services to the healthcare sector, we know that for clinical research to be streamlined, the data must be reliable, accurate and timely, and must be efficiently managed. This is where cloud-based solutions become highly relevant, ensuring improved efficiency and reduced costs. Cloud-based platforms are highly advanced, and have state-of-the-art data management tools that enable real-time visibility of data, and also process, analyze, evaluate and share reliable data with others that need it.
Cloud Storage vs. Cloud Computing
It is very important to know the difference between cloud storage and cloud computing. Cloud storage refers to a model of network of online data repositories where data can be stored and hosted by a third party server. Cloud computing incorporates software into the storage system and offers various mechanisms for managing data. According to the National Institute of Standards and Technology, there are four different types of cloud computing deployment models with many capabilities depending on the objectives of the user:
- Community cloud: This is exclusively used by a specific community of users in an organization who have mutual goals, situated on or off site and managed by one or more of the organizations, a third party or both.
- Hybrid cloud: It is an integration of two or more separate cloud infrastructures like private, community or public cloud which remain distinct entities. They are bound by standardized technology that allows data and application portability.
- Public cloud: This provides open use by the general public. It is located on the premises of the cloud providers and is managed by an academic or government organization or by a business.
- Private cloud: It is used exclusively by a single organization. It is situated on or off site and managed either by the organization, a third party or both.
When it comes to clinical trials management, the new innovative cloud systems are much better than traditional computing systems as the former have many other capabilities. Hybridized cloud infrastructure also includes merging of cloud systems with traditional IT that makes it a popular model in large enterprises. Such infrastructures are agile and scalable.
Cloud System in the Pharmaceutical Industry
How practical is “cloud” implementation in the pharmaceutical industry? The main concerns pointed out include the time to implement, lack of data security and privacy, difficulties maintaining validation and so on. If an organization ensures planning ahead of validation strategies, implementing compliant cloud platforms need not be a major concern. If cloud computing is to be widely embraced in the clinical trials arena, it is important to standardize regulatory compliance, approval from health services, and approval from insurance companies. As regards data security, compliance is mandatory with the Food and Drug Administration (FDA) Title 21 Code of Federal Regulation (CFR), especially part 11, the Electronic Records, Electronic Signature rule that requires computer systems and controls be available for FDA inspection. If investing in cloud technology, it is important to find the right cloud technology provider that can ensure absolute compliance, data security, privacy and integrity.
Advantages of Cloud-based Solutions
- Better study control: Enhanced clinical trials information is available such as user views and permissions, and trial location requirements. As a result, decisions can be made much more quickly by clinical trial managers. Each and every trial location can be monitored in real-time for data entry professionals and requirements. Collaboration can be improved across various sites as well.
- Cost-efficient: Cost related to IT can be reduced with cloud-based solutions as there is no longer the need to rent out space for servers. The time-saving attributed to cloud computing would translate into cost savings.
- Diversity of devices: It enables access to data from any device and the physical location of the study need not be considered.
- Real-time reporting: Cloud-enabled reports provide quality data for risk-based monitoring by making data available in real time with no data transfer lag time. Managers are immediately alerted to serious adverse events.
Future of the Cloud System
Providers of data entry services and data storage solutions including cloud storage have adopted ideal compliance and security measures to provide protection to the clinical research data they handle. This means that outsourcing data management is poised to be an increasing trend. More and more stakeholders in the industry are taking necessary steps to adopt cloud computing for their clinical trials management. Innovative platforms and cloud-enabled products available now can integrate with your existing IT solutions, and ensure a flawless and efficient implementation process.
