“In the midst of every crisis, lies great opportunity” – Albert Einstein

To flourish during the new normal, large and small pharmaceutical companies need to streamline their processes and partner with AI-powered companies to boost successful outcomes, reduce costs, and support growth.

Leveraging the potential of artificial intelligence provides valuable insights that can power successful clinical trials. Navitas Life Sciences has always strived to stay ahead of the curve, with an overarching onus on building the right tools and systems. The deployment of machine learning, as well as other cognitive tools across the organization, even prior to the pandemic, supported data-driven decision making.

Here are six examples of how digital solutions, across the various stages in the drug development life cycle, power successful outcomes during the new normal when partnering with Navitas Life Sciences

1.Study oversight:

Clinical trials have multiple data points that are present in silos, and which result in redundancy and reduced efficiency. Artificial intelligence and machine learning can now be harnessed to better manage clinical trials, and improve clinical trial outcomes.

Our AI platform, OneClinical^®, provides study oversight with near real-time data insight. This helps in proactively identifying risks and in effective utilization of resources. Sponsors have access to dashboards and can analyze study timelines and track progress.

Navitas Life Sciences powers its clinical trials with machine-based solutions that limit subjectivity and bias while driving successful outcomes.

2.Remote Site Monitoring:

Riding on the efficiency of digital solutions, the functioning of clinical trials across various sites have moved from working as isolated sites and integrated into the broader framework of collaboration, allowing remote access. This has played a pivotal role in ensuring continuity of clinical trials during the pandemic.

Regulators and sponsors understood that “one size fits all” is not the way forward, with the European Medicines Agency (EMA) and Food and Drug Administration (FDA) promoting effective and risk based monitoring of clinical trials, in line with changes in ICH GCP E6 R2 Addendum (November, 2016)

Effective Clinical Trials Remote Monitoring Services: We ensured in-depth training in protocol, recruitment, sample, PD/issue handling, data entry and cleaning requirements, good source documentation, and in regulations, and more. We developed a robust plan to track clinical trials and update key stakeholders using CTMS and our OneClinical^® Analytics.

Digital solutions and steps taken for effective Remote monitoring

• e-Source, EDC
• OneClinical^®
• Remote IMP accountability
• Periodic medical data review and pharmacodynamics review
• Synchronization of e-source with EDC

In order to effectively use remote monitoring, risk-based monitoring approach should be utilized to ensure

• Safety, welfare and rights of the study participants
• Quality of the data obtained

Effective Project management strategy for stellar remote monitoring

There are many different aspects to planning an effective clinical trial, from project planning, to effectively communicating with sponsors and stakeholders, to assessing risk, and more. Leveraging the right resources and expertise, we forged ahead to drive successful outcomes for clinical trials, even during COVID-19.

3.Document Management and Regulatory compliance:

Regulatory compliance requires expertise as it is a target that can be affected by human interpretation and bias. Differing views on regulations can make interesting conversations, but algorithms and systemized solutions will help in approvals. This is because digital solutions do not have a fluid process. They are executed based on information provided, helping adhere to regulations, to the T.

Since 2007, Navitas Life Sciences’ pharmaREADY^® has supported regulatory submissions. pharmaREADY^® is a fully integrated, regulatory compliant document management, labeling, and eSubmission publishing solution suite. Submissions management is a complicated processes. Our clients harness pharmaREADY^® to drive organizational efficiency. Currently, there are over 180 satisfied clients who use this digital solution.

4.Organizing data:

A clinical trial results in extensive data, efficient management of such data involving navigation through substantial quantities of code. This critical aspect plays a vital role in your ability to reach the market efficiently.

Our CR Toolkit™ has been developed with an onus on data accuracy and consistency, and a needle eye view on FDA approvals to market life-saving drugs. You can now work efficiently with study reports, organizing, and structuring accurate clinical data, which will enable your life-saving products to get regulatory approval and reach patients faster. CR Toolkit™ helps produce consistent reports, letting you work with any data structure and supporting CDISC standards (ADaM and SDTM).

5.Next Generation Mobility:

Navitas’ traceREADY^® platform provides next generation mobility that allows you to leverage technology to automate manufacturing and warehousing operations. Such innovations help in mitigating errors like product mismatch and aid in collecting data for serialization for an EPCIS repository.

Data insights from assets in the company, like inventory and delivery, are critical for systems' smooth functioning. When such data are fed into digital solutions in near real-time, it will help provide insights that can be leveraged to reconfigure inventory, pricing, recalculate warehouse requirements, and optimize supply chains.

6.Enhanced Digital Communication with Virtual Training Modules:

Multiple communication channels are being leveraged to ensure succinct communication to sponsors or to site personnel. It helps in building a conducive ecosystem that ensures seamless continuity of trials and a digital platform for collaboration.

Navitas Life Sciences provides virtual training modules to help use various digital solutions. Such digital training support will help learn new processes efficiently or refresh an earlier understanding. Optimal use of Office 365, and enhanced data security, ensured completely virtual business as usual

While many companies have begun foraying into artificial intelligence during the pandemic, Navitas Life Sciences understood its value in enhancing its business model. We have been implementing many solutions for several years now and are adept at identifying critical areas in the clinical trial life cycle that require intelligent solutions.

Learn more about how Navitas Life Sciences taps into its resource of digital solutions for productive monitoring of clinical trials, seamless flow of information and insights to propel beneficial collaborations.