Cloud based Clinical Trial strategy development and implementation

Clinical trial sponsors are facing intense pressures to change the way clinical research is conducted in order to decrease costs and speed up the R&D process. This will bring new treatments to market sooner and address unmet patient needs more quickly. A new paradigm is emerging that moves the conduct and management of clinical trials to cloud-based applications. With cloud-based technologies, sponsors can implement an end-to-end data management strategy to transform their clinical development life cycle processes, including data acquisition, storage, aggregation, and analysis. Different applications such as electronic data capture (EDC), clinical trial management systems (CTMS), safety systems, and data repositories can be seamlessly integrated. Cloud-based applications provide sponsors with access to data in real time, as large amounts of data are stored in a central location. Additionally, cloud-based clinical trial platforms enhance collaboration between sponsors and investigators, and allow information to be shared and managed quickly and securely, which leads to increased productivity.

There are now cost-effective and robust cloud-based platforms available to provide insights into your data quickly, easily, and in a format that enhances decision-making. A secure cloud-based platform that standardizes, aggregates, and analyzes clinical data from multiple systems and sources such as EDC, CTMS, legacy studies, clinical research organizations, and partners is becoming essential to achieve these efficiencies.

Additionally, a best-in-class platform will enable consumers across the organization to interact with data, run ad hoc queries, and access data visualizations to proactively analyze clinical and operational data across multiple trials. A key feature of a best-in-class platform is the use of advanced Extraction, Transformation, and Load (ETL) technologies to enable data mapping and standardization based on CDISC standards. Additionally, platforms that offer scalable warehousing, efficient data computing capabilities, a document management system for clinical teams to easily access and use in their trial activities, and a communication portal that streamlines communication between sites and sponsors are able to leverage technology in an integrated manner to meet complex regulatory requirements efficiently.

The benefits of using cloud-based technologies are:
  • Increased transparency and real-time visibility into clinical trial operations and data.
  • Enhanced collaboration between investigators, sponsors, and partners.
  • Increased efficiency and speed to conduct trials.
  • Decreased frustration and costs in completing trials.

An important consideration that should not be overlooked is 21 CFR Part 11 compliance requirements for any clinical system, whether it is cloud-based, hosted by a service provider, or installed on local on-site servers and computers.

There are many tools and platforms available to use in conducting cloud-based clinical trials. As companies evaluate partners to work with through this process, they need to look for service providers that have experience in developing and implementing cloud-based clinical data platforms. Companies should evaluate three key areas for each service provider.

  1. Service Provider Capabilities
    • Existing clients are using their platforms in conducting and managing clinical trials.
    • Staff members have experience and qualifications in managing clinical trials and data management.
    • Proof that the platform and data centers meet regulatory and industry expectations.
    • 24/7 support for any issues that arise with the platform.

  1. Data Security
    • Understand where the data will be stored and processed.
    • Sufficient physical and electronic security measures are in place.
    • Data encryption for applicable data.
    • Robust back up and disaster recovery procedures and plans are in place.
    • Confirm the data are isolated from other data sources and other clients’ platforms.
    • Understand who owns and has access to your data.

  1. On-Site Audit
    • Conduct an on-site audit to evaluate the areas outlined above. Qualified service providers are expecting to address these criteria, and they will willingly share information with you on their cloud-based clinical trial capabilities and data security standard operating procedures.

qointa is here to help! We can work with you to move your clinical trials to the cloud in order to speed up the clinical trial process and reduce costs.

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