Controlling Clinical Data from Collection to Submission

Date: Wednesday, June 3, 2026

Time: 12–1PM ET

Products: Pinnacle 21, CoAuthor, GlobalSubmit

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Summary

Data is the foundation of every successful regulatory submission. In this session, we’ll demonstrate how standardizing data at the point of collection leads to efficiency gains in validation, study report authoring, and regulatory submission. You’ll learn how the right software solutions for standards governance, dataset validation, GenAI powered writing, and eCTD assembly can work in concert to ensure the integrity and flow of your data from “first patient first visit” to regulatory transfer. Your operations can’t afford disjointed workflows. Neither can patients in need. Join the Certara and DIA to explore a practical path from data capture to submission readiness.

This webinar is ideal for:

This webinar is intended for clinical, data, medical writing, regulatory, and technology teams looking to improve how data moves from collection through reporting and submission. It is especially relevant for professionals focused on data quality, submission readiness, CSR development, and regulatory delivery.

Speakers:

Erin Erginer

Senior Director of Product, Certara’s Pinnacle 21

Innovative leader with 20 years of clinical research and healthcare experience, specializing in acquisition, management, and transformation of clinical biospecimen and digital health assessment data. Collaborative creator of tech-enabled solutions for the pharmaceutical industry. Accomplished, analytical director possessing strong interpersonal and communication skills with experience in managing multi-functional teams at both a strategic and tactical level. Key strengths include driving transformational change, strategic planning and execution, spearheading business process improvement initiatives, and building high-performing organizations. Built and introduced countless strategies within R&D to achieve efficiencies and resolve process and application gaps. Experienced in operations oversight and guidance, including resource and financial projections and prioritization.

Nick Brown

Director, Global Portfolio Leader for Certara.AI

Nick Brown is Director, Global Portfolio Leader for Certara.AI; the life sciences-specialized GPT platform. Nick has over 10 years of experience driving AI adoption and customer success across life sciences, federal government and other industries. Prior to Certara, Nick led marketing at Vyasa (now Certara.AI) assisting in the launch and go-to-market strategy for the Layar data platform. He is a graduate of the University of New Hampshire and resides in Andover, MA.

Somya Agarwal

Product Owner

Somya Agarwal is a Product Owner who has spent the last 15 years working on life sciences software development with a focus on eCTD technology. She is a customer-focused professional with expertise in the areas of Quality and Validation Management, SDLC Management, requirement gathering, and UI/UX design. In addition to Somya’s extensive software experience, she has worked with numerous health authorities to help define, build, and implement solutions that assist in the overall submission process.

Somya has held positions at Certara, Synchrogenix, and HCL Technologies where she has demonstrated strong leadership skills and taken various technology initiatives to completion.

Controlling Clinical Data from Collection to Submission

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Summary

Featured topics

This webinar is ideal for: