Navitas Data Sciences and PHUSE: Collaborating for Innovative Solutions in Data Science in Clinical Trials

In the ever-evolving life sciences and data science industry, collaboration and knowledge sharing are vital for advancing research, and development. Navitas Data Sciences, the Functional Service Provider (FSP) for Navitas Life Sciences, providing bespoke global solutions to support Statistical Programming (SAS and R), Biostatistics, and Data Management needs, has established a strong association with PHUSE (Pharmaceutical Users Software Exchange). PHUSE is a Global Healthcare Data Science Community that provides a platform for sharing ideas, tools and standards around data, statistical and reporting technologies.

As data science continues to gain prominence, it is important to understand essentially what is data science, its role and impact in the industry. Data science jobs and internships are in high demand as organizations seek skilled professionals who can analyze data, build models, and communicate insights effectively. For example, Python for data science has emerged as a popular programming language due to its versatility, robust libraries, and ease of use. By supporting various activities promoted by PHUSE, there is combined access to expertise, networks, and resources to drive innovation, streamline operations, and shape the future of the life sciences industry.

Navitas Data Sciences has participated in multiple events organised by PHUSE. We showcased as a Platinum Sponsor at the PHUSE US Connect 2023, and have a long-standing association with PHUSE US Connect, showcasing as a Platinum Sponsor/Exhibitor since 2020 and as an Exhibitor since 2018. Prior to that, our experts attended Single Day Events (SDE) from 2012. Read more here.

In our latest blog, we met with Senior Vice President, Navitas Data Sciences (a part of Navitas Life Sciences), Shrishaila Patil who continues as PHUSE India's Single Day Event Lead, to find out more about the activities he has been involved with as a part of PHUSE and the events lined up for the coming year.

What are some of the key challenges that you have encountered in applying data sciences to clinical trials, and how have you overcome them?

Data science plays a crucial role in driving informed decision-making. Data scientists are not only skilled analysts but also skilled storytellers, as they delve into data, clean and transform it, build and validate models, uncover patterns, generate insights, and effectively communicate the results. To meet industry challenges, there is a growing demand for sustainable technologies and tools that can provide optimal solutions in data analysis.

At Navitas Data Sciences, we recognize that a one-size-fits-all approach is inadequate. Therefore, we are committed to embracing efficient data science technologies and tools such as R, SAS, or Python. These help manage large datasets, including big data and real-world data, while ensuring improved accuracy and faster processing using data science in clinical trials data.

By leveraging these advanced technologies, Navitas Data Sciences enhances its capabilities to navigate the complexities of data analysis in drug development. The efficient processing of data empowers us to gain deeper insights, which in turn enables improved decision-making across various stages of the drug development lifecycle. We are dedicated to staying at the forefront of data science advancements and employing the most suitable tools and technologies to provide optimal solutions for our clients in the life sciences industry.

How has the use of data sciences in clinical trials evolved over the years, and what new opportunities or advancements do you foresee in the near future?

To effectively manage the challenges posed by vast clinical data, continuous innovation is required in various technological aspects. These include the adoption of Artificial Intelligence (AI) and Machine Learning (ML) technologies, Robotic Process Automation (RPA), and Blockchain. Additionally, novel data collection instruments such as wearables, sensors, and eSource solutions are being utilized, while maximizing the value of Electronic Data Capture (EDC) and developing Intelligent Clinical Data Management Systems (CDMS) for real-time, data-driven decision-making.

The volume of data has significantly increased, transitioning from a few data points per Case Report Form (CRF) to thousands or even millions of data points per patient per week. Apart from EDC, data is now sourced from various other channels, including Real World Data (RWD), biomarkers, genomics, imaging, video, sensors, and wearables. This introduces structured and unstructured data, and the speed at which data is generated is nearly real-time, unlike the traditional eCRF data entered over days, weeks, or months. Ensuring data credibility and reliability is crucial, with a focus on what matters (critical to quality factor), risk-based data strategies, AI-driven automation for issue detection and resolution, and the implementation of fit-for-purpose solutions that are scientifically plausible and strong enough to support the reliability of trial results. Standards like RESTful Application Programming Interfaces (APIs) facilitate interoperability between computer systems.

Navitas Data Sciences is dedicated to staying at the forefront of these technological advancements, leveraging their potential to tackle the complexities of managing clinical data in the modern age.

As the PHUSE India Lead, could you share your experience and the role PHUSE plays in promoting collaboration and innovation in the field of data sciences for clinical trials?

PHUSE is an independent, not-for-profit organisation run by a worldwide team of volunteers. We are a global community and platform for the discussion of topics encompassing the work of data managers, biostatisticians, statistical programmers, data scientists and eClinical IT professionals. PHUSE has become the industry voice to regulatory agencies and standards organisations such as the FDA, EMA & CDISC.

PHUSE is very close to my heart, and I have been associated with PHUSE since 2015 in various capacities like Volunteer, Presenter, Chair, Events co-ordinator, Membership Officer, Producer for multiple Single Day Event (SDEs).

The PHUSE Board nominated me as "PHUSE India Events Lead/Officer," effective from Jan2022 (for the next few years). In this role, I will be associated with

• leading & conducting all the PHUSE SDE events in India. In general, we have four events per year.
• Actively involved in identifying Chairs, Presenters, Keynote speakers, Panel members & Sponsors for each event.
• Working to build a Team of Volunteers from India
• Contributing globally to PHUSE Working groups, Education & other initiatives

I am extremely grateful to PHUSE for the invaluable opportunities it has provided me. Through PHUSE, I have had the chance to collaborate with industry peers, learn and exchange best practices, share knowledge, foster innovation, and contribute to the overall growth and development of the statistical programming community in India. PHUSE has been instrumental in facilitating a platform for collaboration, learning, and professional advancement, enabling me to broaden my horizons and make meaningful contributions to the field. I am truly appreciative of the support and resources PHUSE has provided, which have been essential to my professional growth and success.

How does PHUSE view Navitas Data Sciences in terms of its contributions to the field of data sciences and clinical trials?

Navitas Data Sciences have sponsored many key PHUSE events across the world consistently and supported PHUSE activities.

PHUSE community platform promises connection and knowledge sharing, which, ultimately, drives development in life sciences. With this, PHUSE is committed to providing open access to knowledge resources for industry professionals. Navitas supports this and shares passion for collaborative work and collective purpose as an industry.

What have been the key milestones in your two year journey as the PHUSE India Lead

Since January 2022, as the India PHUSE Lead, I have achieved successful delivery of five events as outlined below. Throughout these events, I played an active role in identifying and engaging chairs, presenters, keynote speakers, panel members, and sponsors to ensure their valuable contributions

In 2022, I worked to bring in sponsors, and have currently facilitated the support from over 20 sponsors for PHUSE India SDEs, further enhancing the quality and impact of these events. Building on this success, in 2023, as of May, I have already identified over 15 sponsors, indicating significant growth and industry recognition for PHUSE India SDEs.

These achievements highlight my dedication to fostering strong partnerships, promoting industry collaboration, and providing exceptional opportunities for knowledge sharing and professional development within the Indian statistical programming community. I am committed to continuing this positive momentum, facilitating further growth, and ensuring the success of future PHUSE events in India.

PHUSE is a well-respected organization in the pharmaceutical industry that focuses on promoting the use of data sciences in clinical trials. They bring together industry experts, regulators, and academia to exchange knowledge, share best practices, and collaborate on initiatives related to data management, analysis, and reporting.

Given focus on data science, Navitas Data Sciences has actively engaged with PHUSE and contributed to the field of data sciences in clinical trials through collaborative efforts, and thought leadership.

Please tell us more about your industry-academic collaborations

PHUSE India team conducted a series of visits to universities in India as part of an industry-academia collaboration to spread awareness about our activities, data science jobs, data science internships and the opportunities available.

PHUSE works with professors to understand the challenges faced by the industry and mentorship of students. Recently the team visited colleges in Bengaluru, Hyderabad and Delhi

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