Simplify Clinical Trial Processes with Automation, AI and Cloud Enablement

In the previous two blogs, blog 1 & blog 2, we have built the premise that technology can bring efficiency in clinical trials through cost optimization, and effectiveness through data insights. Now let us understand the challenges of the clinical process and how technology plays a key role in simplifying the processes for best outcomes and compliance adherence.

Clinical Process – Expectations & Challenges

Let us start by looking into the critical capabilities that processes in a clinical trial industry need to have in order to support the business transformation needs of the future:

Currently, in the Covid period, there is enormous pressure on the clinical industry to be able to innovate in the most cost-efficient way. The ask is tough – considering the complex procedures / therapies that are often needed for specialty diseases and stringent global regulations. Due to the importance of trials to human health and regulatory risks, many reviews / supervisions are conducted, and they require large amounts of manual effort of a very specialized workforce. This effort needs to be coordinated across the globe (with global sites and multiple regulatory bodies).

Towards a more Digital and Efficient Enterprise

Paper-based rigid legacy processes are things of the past for clinical trials. Flexible, digitalized processes with increased automation and smart capabilities such as AI/ML and deep learning will be the future of clinical trials. Cloudification is another very important aspect of this journey – leveraging the scale and reach of cloud, its native services around areas like AI/ML, chatbots, APIs, etc.

Automation can be applied across all layers such as customer experience, business process, application layer and underlying infrastructure. There needs to be an enterprise-wide holistic approach to automation leading to orchestrated intelligent services.

• Transform experiences of stakeholders like patients, trial investigators, sponsors, etc. by using digital channels, self-service, intelligent chatbots and IoT-enabled smart devices.
• Automate and optimize business processes of investigator payment, contract creation, case intake using BPM / RPA, etc.
• Provide relevant data, application functionality and intelligence through APIs to support the business processes and engagement
• Automation-led maintenance of secure, scalable, compliant (e.g. GxP, HIPAA) and optimized infrastructure with high availability

Compliance with Digitization

In order to adapt to the changing needs of the market, various systems and processes of the clinical trial system should be integrated. The synergies created by the inter-connectedness will help the clinical products to reach the market faster. This is becoming more achievable as the industry embraces cloud as the new operating model. This also means regulatory concerns and challenges increase along with the need to maintain privacy, security of patients and stakeholder’s data. With an increased movement towards global trials, clinical applications also need to adhere to regulatory requirements based on geography.

CROs and pharma organizations are already taking some initiatives – like focus on specific therapeutic areas, site clustering, better planning of global supply-chain to better focus on certain areas and execute them efficiently. This needs to be augmented by efficient digital processes and reliable and complete datasets. This will help the clinical industry to operate efficiently and get the desired outcome as it encounters new diseases and discovers solutions for treating those along with existing diseases.

If you are in the clinical research business and would like to know more about how the latest technologies can be leveraged for cost efficiency, data optimization and streamlined clinical processes, get in touch at marketing@hexaware.com