Navitas Data Sciences will be at the PHUSE India Autumn Single Day Event

Navitas Data Sciences, a part of Navitas Life Sciences, is a media sponsor for the upcoming PHUSE India Autumn Single Day Event to be held on 17 September 2022. PHUSE is a Global Healthcare Data Science Community where ideas, tools, and standards around data, statistical, and reporting technologies are shared.

Navitas Data Sciences is a global Functional Service Provider (FSP) with solutions for all your statistical programming, biostatistics, and data management needs. Our Biometrics expertise supports all clinical trial phases throughout the drug development life cycle. Our blended team of highly skilled experts provides complete data support or augments your existing team.

Global Functional Service Provider for all Biometric Needs

Navitas Data Sciences offers a range of bespoke FSP models assembled to fit varying sponsor needs or budgets. Here are the advantages of an FSP model:

• Sponsors save on recruiting fees
• Lower human resources management fees
• Sponsors save on training cost
• Improved services provider relationships
• Increased resource flexibility
• Provides access to a specific skill/expertise

Shrishaila Patil, Senior Vice President, Navitas Data Sciences, has been nominated as PHUSE India's Single Day Event Lead. Shrishaila and our Associate Manager and Statistical Programmer, Ram Mohan Konda, will be at the event to share their unique insights. We caught up with them for a short interview to understand more about their roles and to shine a light on their experiences.

Navitas Data Sciences' Shrishaila Patil will be producing his third event in his role as India SDE Lead for 2022.

Tell us about your professional journey

I have a master’s degree in Biotechnology from Bangalore University and approximately 18 years of experience in Drug Development. I am the Senior Vice President at Navitas Data Sciences, heading the Statistical Programming department, India.

I am a "CDISC Volunteer" & "PHUSE India Events Officer." I have supported the "R Package Validation Framework" and "Open-Source Technologies for Regulatory Submissions" projects in the PHUSE working group "Data Visualization and Open-Source Technology in Clinical Research (DVOST)."

I have authored a book titled, "FDA Clinical Outcome Assessments and CDISC QRS supplements," under the "Clinical disciplines" category with the LAMBERT Academic Publishing Group.

Shrishaila Patil

Senior Vice President,

Navitas Data Sciences

What makes the PHUSE India Autumn Single Day Event special?

The PHUSE India Autumn Single Day Event (SDE) is on 17th September 2022 (Saturday). Post Corona, this is the first physical Single Day Event planned in India. Registration is free & open to all.

This will be a hybrid event and held at the GSK Office, Bangalore. Participants can choose to attend physically or virtually.

The Theme of the discussion is "Data Analysis and Reporting of New Age Clinical Trials (Automation in Clinical Programming, Standards, Latest Protocol Designs, RWD, RWE, etc.)." We have interesting presentations on topics like "Innovation & Patient Centricity," "Master Protocols," "RWD & RWE," "Cloud-based Analytics Solutions," "Automation," and "Developing Datasets for Synthetic Control Arms," etc.

How did you become the India SDE Lead for 2022? What are your responsibilities?

I have been associated with PHUSE since 2014. I have been a Volunteer, Presenter, Chair, Events Coordinator, and Producer for multiple Single Day Events (SDEs) in India for many years. I took the India PHUSE Membership Officer role in 2018 (Supporting the membership drive in India and building the PHUSE community).

The PHUSE Board nominated me as "PHUSE India Events Lead/Officer," effective from 2022 (for the next few years). In this role, I will be associated with

• Leading and 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, and Sponsors for each event.
• Working to build a Team of Volunteers from India
• Contributing globally to PHUSE Working Groups, Education, and other initiatives

PHUSE is very close to my heart, and it has given me the opportunity to

• Collaborate across Industry peers,
• Learn and share best practices,
• Contribute to the overall growth and development of the Statistical Programming community in India.

What are the new trends to look out for in Data Analysis and Reporting of New Age Clinical Trials?

Here are some of the latest trends to look out for:

• Technology enabled data, previously siloed, to be translated into insights that help to find the right solutions to treat diseases. It can empower patients, caregivers, and providers to get the correct information at the right time and improve decision-making, which leads to better outcomes. Digitization has helped immensely in reaching the required patient populations.
• Real World Data (RWD) has the potential to provide answers to essential questions. RWD may come from multiple sources, including electronic health records (EHRs), medical claims and billing activities, product and disease registries, patient-generated data (including in home-use settings), and data gathered from sources that can inform on health status, such as mobile devices. Real World Evidence (RWE) is the clinical evidence regarding the usage and potential benefits, or risks, of a medical product derived from the analysis of RWD. Technology can help streamline care and improve access to care.
• Innovation is needed to move away from traditional inefficient processes and tools towards efficient, simple, easy-to-implement, reliable, and cost-effective solutions.
• Collaboration across industry stakeholders is needed to develop better technology ecosystems and to agree on validation and regulatory benchmarks.

Tell us about your professional journey

I am Ram Mohan Konda, a SAS Professional with over 17 years of experience in the Pharmaceutical Industry. I hold a master's degree in Statistics from Osmania University, and I am an Associate Manager, SAS Programming at Navitas Data Sciences. My work experience includes Docs Global, Cytel, Iconplc, Accenture, I3 Statprobe, Genpact, and Sristek. I have experience in Phase I to IV trials and end-to-end programming tasks like SDTM Creation to TLF Generation.

How can expert data analysis support power-efficient clinical trials?

Big data, advanced analytics, AI, and machine learning can help tap into clinical trial data, transforming it into valuable insights—accelerating research and bringing medicine to patients faster. Data Analysis can help maintain site compliance when it comes to data entry or data collection.

Ram Mohan Konda

Associate Manager,
SAS Programming,

Navitas Data Sciences

What are the Clinical Data Services provided by Navitas Life Sciences?

Navitas Life Sciences is a company that delivers clinical, regulatory, and safety solutions and services. It has expertise in strategic clinical consulting, clinical trials, clinical data, strategic regulatory consulting, license maintenance, and IT services.

Please give us a brief insight into your session on Automation by Macro’s in SAS programming for the PHUSE India Autumn Single Day Event.

We have some unique tables and listings with respective ADAE, ADMH, and ADCM datasets, etc. Automating unique tables and listings creation using macros would help avoid repetitive tasks and generate results faster, while validation efforts can be reduced and cost-effective.

We have chosen a simple example of creating a table for easy demonstration in the PHUSE Single Day Event presentation. In SDTM or ADaM datasets, programmers must derive EPOCH, SEQ, and –DUR variables. Deriving these variables in each domain is a time-consuming, repetitive process that is a uniform task across all domains. This presentation covers objectives, number of studies used, exceptional handling, manual time for the programmer to develop macro, advantages of macro, and effort involved in the macro validation.

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