Driving Productivity through eClinical Management Systems

Pharma Tech Outlook: Pharma Tech Magazine

Driving Productivity through eClinical Management Systems

By Ramkumar Rayapureddy, Global CIO, Mylan

Ramkumar Rayapureddy, Global CIO, Mylan

The surge in clinical trials across the world has led to an increase in the volume of data pertaining to new drugs, ailments and their outcomes being recorded. The increased inflow of data coupled has enabled organizations to manage clinical trial data electronically. This has placed a new responsibility of deploying eClinical Trial Management Systems on the CIOs of pharma companies, for reaping greater benefits.

Factors that Necessitate eClinical Trial Management Systems

The challenges presented by the data proliferation are aplenty. In a typical scenario, no pharmaceutical company works with a single clinical trial provider, but a plethora of them. With clinical trials being conducted at multiple places and each company sharing the information, a cloud environment storing the data for the highly mobile workforce in clinical trial management domain to access becomes necessary.

"Automation lies at the crux of addressing the challenges prevalent in enabling eClinical Trial Management"

Also, the sharing of clinical trial data between multiple players could potentially render the data vulnerable to hacking. This calls for the development of an exclusive data communication protocol that transmits or receives data packets in specified formats. The formats are designed to address all the security concerns so that data is accessed only by the intended users.

Addressing these challenges requires the CIOs of pharmaceutical companies to collaborate with multiple teams to understand the needs of their employees and convince the executive boards to invest on the Information Technology (IT) solutions to facilitate eClinical Trial Management.

Disruptive Technologies to Combat the Challenges

Automation lies at the crux of addressing the challenges prevalent in enabling eClinical Trial Management. The Internet of Things (IoT) is also gearing up to disrupt clinical trials, by eliminating the scope for all errors due to manual intervention. For example, attaching a barcode to a blood sample and scanning it to update a repository offers greater accuracy than populating and updating the same repository manually. Needless to say, the data repository has to be a cloud environment accessible from a mobile device. Artificial Intelligence (AI) has also begun to make inroads into the pharmaceutical sector, to hasten data capture, impacting eClinical trials positively. With a huge data inflow, Predictive Analytics would provide more insights into the eClinical trial data.

Choosing the Right Vendor

Technology can empower eClinical trials but finding the right vendor or solution providers, capable of supporting advanced technologies to meet the user requirements, is critical for companies. While cost is important, eClinical Trial Management System applications ought to comply with the requirements for simplifying the workflow, as opposed to solving only a particular part of the problem with high efficiency. The application has to be compatible with the existing data infrastructure including the server and the cloud, plus the security challenges to it after deploying the application need to be thoroughly perused. With the compatibility and security in place, the next important parameter to monitor would be the ease and intuitiveness of using the application. An easily configurable application with minimum need for customization is always desirable as opposed to one that requires the organizations to invest resources on configuration.

Examining the solution providers’ track record to understand their technical skills and the ability to keep in pace with the ever-changing changing regulatory requirements, is also vital. Global support for applications, assures greater levels of scalability to the companies, which is crucial during expansion plans.

Preserving the Data Integrity

Maintaining the data integrity is of utmost priority to all verticals and eClinical trials is no exception. Hence, following the deployment of each application whether in the cloud or in-house, a comprehensive risk assessment program is necessary for understanding new vulnerabilities, if any and the possible remedies for it. This combined with procedures like access control and periodic check of how they function, fortifies the data environment.

Preserving the enterprise data integrity also requires CIOs and CISOs to strike a balance between their defined roles. With clinical systems that are governed by different privacy regulations differing with each country, meeting the regulatory requirements is always prioritized; hence CISOs always have the final say.

Safeguarding enterprise data must also be a key priority for a CIO. Companies often focus on external threats, overlooking the loopholes internally. In a significant number of cases, cyber security breaches have happened due to disgruntled employees. Therefore, identifying and grooming the right talent and keeping track of their activities, is extremely important and helps in business.

CIOs today have an advisory role in almost all areas of business within a company, which requires them to possess good technical skills and strong business acumen. Therefore, understanding the company’s line of business and keeping abreast of the rapid changes occurring in the technology landscape, to design robust internal processes to fortify the enterprise is a skill that companies typically look for, in a CIO.

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