Working Group Scope 

The Real World Evidence Working Group aims to support, address and answer pertinent questions around real-world evidence. The Working Group is dedicated to sharing across the PHUSE Community (through Community Forums) and aligning on the best industry practices. Some of the questions we intend to address are:

  • What are the requirements, technologies and processes needed to use real-world evidence as a source for data analysis?
  • What are the requirements, technologies and processes needed to incorporate real-world evidence into clinical trials?
  • What are the requirements, technologies and best practices needed to support the use of real-world evidence as part of regulatory submissions?

Berber Snoeijer: Working Group Lead

Berber Snoeijer started in clinical research in 1997 as a biometrician and has since then worked with clinical data in different functions. In 2001 she started a CRO – Biometric Support – aimed at the data management, data analysis and reporting of clinical trials. In 2011 she started as an R&D manager dedicated to investigating and utilising the potential of real-world data from electronic health records. This resulted in many different solutions including a full reporting system to give feedback information to clinical research professionals. Berber is experienced with software and database engineering, process engineering and improving efficient utilisation and interaction of people based on management drivers. Nowadays, she uses these skills and knowledge to help life science companies assess, design and improve business solutions and processes at smaller and larger scales.

Parag Shiralkar: Working Group Lead

Parag Shiralkar has over 19 years of experience in the pharmaceutical and biotech industry. He has taken operational, managerial and executive leadership roles in the functions of data operations, biostatistics and statistical programming. In his tenure, Parag has worked on almost all aspects of data operations and analysis involved in clinical trial data used in the context of the drug development process. He has led the execution of statistical programming activities for various regulatory submissions in the Immunology, Rare Disease, Infectious Disease and Oncology therapeutic areas. Parag’s current career interests include frameworks for appropriate use of real-world data (RWD) for clinical as well as medical research, risk-managed use of open-source technologies, and application of AI/ML in the statistical reporting environment. He has completed master’s degrees in biostatistics and in business administration. Parag is President of Sumptuous Data Sciences and is based out of New Jersey, USA.

Rabia Ahmad: Working Group Lead

Rabia Ahmad is a Programming Director within the GSK Oncology therapeutic area. She is the project programmer for two oncology assets and closely collaborates with the Value Evidence and Outcomes team on the RWD/RWE component for these assets. In addition, Rabia is the project lead for the Oncology Standards Group, representing oncology programming in various internal working groups and closely collaborating with stakeholders to develop robust end-to-end oncology-specific programming standards and guidance at the core level.

Rabia is a frequent presenter at the PHUSE US Connect, she has co-authored the “Oncology Overview” for the “Therapeutic Areas” and authored the “ADRG Overview” for the “Clinical Documents” education clusters, respectively. She is also the Co-Chair for the Real World Evidence Working Group.

Rabia has an MS in Biostatistics from Rutgers University, New Brunswick and is based in the United States.

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