Clinical research is evolving rapidly, requiring trial protocols to be scientifically robust, digital, interoperable, and globally standardized. Traditional protocols often lack clarity and reusability, leading to inefficiencies in design, implementation, and regulatory review.
The Clinical Electronic Structured Harmonised Protocol (CeSHarP) addresses these issues by providing a structured, digital, and standardized framework for protocol development across the clinical research lifecycle.
This webinar, “CeSHarP: Shaping the Future of Clinical Protocols,” will explore how CeSHarP improves protocol design, review, and implementation by enabling machine-readable content, standardized data elements, and integration with downstream systems like electronic data capture and regulatory platforms.
Key Takeaways:
Attendees will learn how CeSHarP enhances protocol quality, reduces amendments, accelerates study start-up, and aligns with global data standards, supporting the digital transformation of clinical trials. Designed for clinical researchers, medical writers, and regulatory stakeholders, the session highlights how CeSHarP is driving efficiency, consistency, and digital readiness in clinical research.
- Learn how CeSHarP enables structured and standardized protocol development.
- Discover how machine-readable protocols improve consistency, efficiency, and reusability.
- Understand how CeSHarP drives digital transformation in clinical research.
About the Speaker:
Ram Sunil Veerubhotla is an accomplished medical writing professional with15 years of experience in scientific and regulatory writing, clinical research, medical devices, and audit compliance.
He holds a Master’s degree in Pharmaceutical Sciences from the Idaho State University (ISU). Ram is a strong advocate for innovation in medical writing and driving the adoption of automation and agile methodologies in regulatory medical writing and has led cross-functional initiatives that leverage AI and automation tools to enhance efficiency and quality. His expertise includes preparing clinical and medical device documents for numerous regulatory submissions, including CSRs, protocols and amendments, informed consent forms, RWE reports, CERs, technical documents, and PMS documentation in alignment with EU MDR, US FDA, NMPA, and PMDA requirements.