Controlling Clinical Data from Collection to Submission

日期： 2026 年 6 月 3 日, 星期三

时间： 12–1PM ET

产品： Pinnacle 21, CoAuthor, GlobalSubmit

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概述

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.

演讲嘉宾：

Erin Erginer

Senior Director of Product, Certara’s Pinnacle 21

具有 20 年临床研究和医疗保健经验的创新领导者，专注于临床生物样本和数字化健康评估数据的获取、管理和转换。为制药行业提供技术化解决方案的协作创造者。多才多艺的分析总监，具有良好的人际交往和沟通能力，并具有在战略和战术层面上管理多职能团队的经验。主要优势包括推动转型变革、战略规划和执行、带头进行业务流程改进计划，以及组建高绩效的组织。在研发部门中制定和引入了无数的策略，以实现效率并解决业务流程和应用软件之间的差距。在业务运营监督和指导方面经验丰富，包括资源和财务预测及优先排序。

Nick Brown

Director, Global Portfolio Leader for Certara.AI

Nick Brown 是生命科学专业 GPT 平台 Certara.AI 的全球投资组合总监。Nick 在推动生命科学、联邦政府和其他行业的人工智能应用和客户成功方面拥有超过 10 年的经验。在加入 Certara 之前，Nick 在 Vyasa（现为 Certara.AI）领导营销工作，协助 Layar 数据平台的发布和市场推广战略。他毕业于新罕布什尔大学，现居住在马萨诸塞州安多弗市。

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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概述

Featured topics

This webinar is ideal for: