Biography: Sarvesh has been associated with PHUSE since 2014. He started as Co-Chair for a Single Day Event (SDE) in 2014 and became Asia Events Director, managing events in India, China and Japan. The Board was later updated and Sarvesh was nominated as APAC Director, overseeing all PHUSE activities in the Asia Pacific region.

Biography: Hanumanta Karedla has over 18 years of experience in the Biostatistics and Statistical Programming area and is currently Head, Oncology Data Analytics at Bayer Pharmaceuticals. Before joining Bayer, he worked as Deputy General Manager for the Biostatistics and Statistical Programming team at Cognizant Technology Solutions. Hanumanta started his career in a statistics teaching faculty at the Osmania University campus, later moving to the International Crops Research Institute for the Semi-Arid Tropics (ICRISAT).From there, he joined Novartis in Clinical Trial Reporting as a biostatistician.He has worked as a lead statistician, been part of key submissions to regulatory agencies, managed large end-to-end engagements with sponsors as well as hiring, mentoring and supervising teams. Hanumanta has a master’s degree in statistics from Osmania University.

Biography:Raghuram Thata has over 22 years in the functional process outsourcing space, specialising in data acquisition, analytics and insights. He has worked across IT, BPO, pharma and CRO organisations. He is passionate about process re-engineering, innovation, and LEAN 6 Sigma, and brings cross-functional teams together to provide solutions and possibilities. Raghuram has worked closely with EDC product companies, third-party laboratories, standards and process owners on various initiatives which have helped reduce cycle time, bring new data elements/evaluations to light, challenge old processes, embrace technology to improve quality of clinical trials and reduce burden on patients.

Raghuram is Senior Director and Global Head of Data Management Programming Shared Services at IQVIA. He has a bachelor’s in statistics and a master’s in computer applications.

Abstract:The concept of meeting patients where they are for carrying out clinical trials significantly predates the COVID-19 pandemic. Its aim is to improve patient convenience and experience. Decentralisation also reduces workload for trial investigators, since traditional site activities (such as drug administration, assessments and data verification) can be performed remotely by other trained personnel or by trial participants themselves. This shift has been enabled by evolving technologies and services. Tools such as electronic consent, telehealthcare, remote patient monitoring and electronic clinical outcome assessments (eCOAs) allow investigators to maintain links to trial participants without in-person visits. Mobile and home healthcare, as well as alternative care locations, enable more procedures to occur away from research sites. The presentation will delve into diverse options and current experience in implementing a broad spectrum of decentralised and hybrid clinical trial designs.

Biography:Kishore Kumar is a senior clinical research professional with extensive experience in drug development and a postdoctorate in statistics. He has been instrumental in developing the analysis and reporting service capabilities in biotech, pharma, CROs and leading academic and research institutions. In his last role as a practice leader at Cognizant, Kishore developed the analysis and reporting team to be one of the largest teams in biostatistics and programming globally. Currently, Kishore works at Consilx, a life science focused organisation, as a Co-Founder and Chief Data Scientist. Consilx is developing solutions to optimise and transform clinical trial processes. This includes a patient-centric decentralised clinical trial platform.

Abstract:In light of the COVID-19 pandemic, which hopefully is nearing its end, clinical trials were cancelled or put on hold. In-person doctor visits became virtual and that’s where the virtual conduct of clinical trials gained momentum, specifically for pragmatic clinical trials, which are conducted during primary care. A good example would be the obesity study, which was conducted via telephone calls, video calls, online orders of planned meals and fitness trackers. As with other methodologies, this had its pros and cons. The biggest and best advantage was the continuity of the clinical trials. This was the best way to discover how various branches of science could co-ordinate and work well so that society in large could benefit from that.

Biography: Prathibha Hanagodu is a global head of the biostatistical programming group at Premier Research. She has 17 years of industry experience, working on various therapeutic areas, multiple phases of clinical trials and submissions both in the CRO world and the biotech industry. Prathibha has more than a decade of people management experience and enjoys mentoring, training and working with people across the globe.

Abstract:With the emergence of COVID-19, a need to change how clinical trials are executed has driven an industry-wide push towards a different approach to traditional trials. To facilitate the adoption and appropriate use of mobile technology in clinical trials, the Clinical Trials Transformation Initiative (CTTI) initiated the Mobile Clinical Trials (MCT) Program, which includes four projects focused on the following topics: Decentralized Clinical Trials (DCTs), Novel Endpoints, Stakeholder Perceptions and Mobile Technologies. The MCT DCT project concentrates on the actual and perceived legal, regulatory and practical challenges with DCT design. DCTs are defined as those executed through telemedicine and mobile/local healthcare providers (HCPs), using procedures that vary from the traditional clinical trial model (e.g. investigational medical products [IMPs] being shipped directly to the trial participant).

Biography:Prasanna Parthasarathy has over 13 years of experience in the clinical industry and has worked in pharma since graduating from university. Currently, Prasanna is working as a Principal Stat Programmer at Syneos Health and, in his current role, works on end-to-end SPA programming activities. His core area, however, is SDTM programming and he is one of the SDTM SMEs for his group. He has vast experience across the industries and has a strong knowledge of CDISC concepts. Prior to Syneos Health, Prasanna worked at ICON, PRA Health Sciences, Accenture and Thomson Scientific. He presented papers at the PHUSE Delhi event in 2017 and the Virtual SDE in December 2021.

Abstract:eConsent, ePRO and eCOA have been around for a while, so then why are we discussing it again? According to Business Wire, around a billion wearables are in use today and the adaptations are growing exponentially. These wearables are now technologically advanced and affordable enough to be used for ePRO and eCOA in decentralised clinical trials widely. When used effectively, ePRO and eCOA with wearables can save money, and increase the patient experience and compliance with the regulators. Patients will have the flexibility to provide data from anywhere and be more willing to share sensitive data, which they might not be comfortable to do in person. Wearable data will also capture audit trail, event location, user, timestamp and an electronic signature complying with 21 CFR Part 11. The data can be transmitted and analysed in real time for AE, SAE and/or RWE. Some of the Phase IV clinical trials can be done fully using these wearables with eConsent, ePRO and eCOA.

Biography: Kumaresh Jha has 15+ years of experience in life sciences as a statistical programmer, with significant experience in multiple projects for Business Process as a Service (BPaaS). Kumaresh is proficient in statistical programming activities for Phase I to III clinical trials including CDISC, submission packages, ADaM and TFLs. He is part of the standards team to set up global standards for CDISC and TFLs. Kumaresh is currently Product Manager for Saama’s smart series, SAM (Smart Auto Mapper).

Abstract:The pandemic’s effect on clinical testing is a tale of two outcomes. On one hand, it has been devastatingly disruptive. About 80% of non-COVID-19 trials were either stopped or interrupted. On the other hand, it made it a necessity. The brick-and-mortar approach of having patients travel to set clinical sites has been replaced by an all-round adoption of tools such as virtual/decentralised clinical trials (DCTs), telehealth visits, remote patient monitoring (RPM)and use of real-world data (RWD). The advent of these new practices has taken root and will have a lasting impact on how clinical trials are designed and conducted.

This presentation will discuss challenges, the edge given by AI and other emerging technologies, and the future of virtual trials.

Biography:Dimpy Modak is a Sr. Manager, Statistical Programming at ICON Clinical Research. With over 13+ years of experience, she has held various roles in clinical programming with a focus on emerging technologies. She fosters the thought that workplace is a community where people bond around shared values, feel valued and have a voice in decisions that impact them. Dimpy’s educational foundation in science drives her passion to collaborate between operations and data science to strategise optimal ways of programming.

Abstract:The pandemic’s effect on clinical testing is a tale of two outcomes. On one hand, it has been devastatingly disruptive. About 80% of non-COVID-19 trials were either stopped or interrupted. On the other hand, it made it a necessity. The brick-and-mortar approach of having patients travel to set clinical sites has been replaced by an all-round adoption of tools such as virtual/decentralised clinical trials (DCTs), telehealth visits, remote patient monitoring (RPM)and use of real-world data (RWD). The advent of these new practices has taken root and will have a lasting impact on how clinical trials are designed and conducted.

This presentation will discuss challenges, the edge given by AI and other emerging technologies, and the future of virtual trials.

Biography:Shivaram Nagabhushana Sharma is a Sr. Manager in Statistical Programming at ICON Clinical Research, with 14+ years of experience. His stakes span managing the programming team, sharing best practices in programming and providing technical, operational and managerial guidance in carrying out work assignments. Shivaram is passionate in building dynamic teams, identifying individual and team strengths, and developing SMEs. He identifies opportunities to implement SMART solutions to enhance processes in statistical programming and operations.

Astract:Decentralised clinical trials emerged as an opportunity during COVID-19 to reimagine the traditional clinical trial model and transform how research studies are conducted, keeping the patient at the centre. Projections indicate a steep rise of 28% of clinical trials with the decentralised component, which also represents a significant boost of 93% since 2020. Embracing decentralised trials is not a ‘plug and play’ solution. Industry benchmarks, technologies, ecosystems to run the trials, expectations of authorities, etc. are being explored and debated around the theme. Decentralised trials may have solved problems but they have created new ones as well. Enhanced patient experience with reduced travel burden and disruption of daily life may be challenged by the reliance on digital literacy levels and facilities conducive for patients. The right technology, the learning curve for research staff, digital literacy of patients and caregivers, data privacy and regulatory acceptance of virtual data collection are some of the challenges discussed pertaining to DCT, along with key benefits of better inclusion and diversity in patient recruitment, better retention, enhanced data quality, improved long-term follow-up and the opportunity to run trials faster in readiness for emergencies such as pandemic and war. This session will explore DCT with multifaceted dimensions to evaluate its fate: “DCT – boom or bust?”

Biography:Sujith Kurup serves as Director for Software Development at IQVIA. He has over 18 years’ experience in the health and life sciences industry and has previously worked at companies like Accenture, UnitedHealth Group, ICON Clinical Research and Bioclinica. A seasoned professional, Sujith has worked in all facets of data management with a particular interest in programming and analytics. He is a Medidata-certified train the trainer and a certified study administrator and programmer on RAVE. He is also a certified project management professional from PMI. Sujith has also served on the global committee on SCDM membership and is a former member of the India SCDM steering committee.