Our services cover a wide range of regulatory submissions, including those to the FDA, PMDA, and NMPA. Whether it's for new drug applications, investigational new drug submissions, or post-marketing activities, we ensure that your data aligns with CDISC standards for regulatory compliance.

The process typically involves CRF creation, data collection, SDTM/SEND data mapping and creation of databases and their metadata specification, ADaM dataset creation and their metadata specification, Define.XML generation, SDTM/SEND/ADaM/Define.XML validation, and the creation of study data and analysis data reviewer’s guides. Typically, most of these steps occur simultaneously, all thanks to our well connected team of experts – clinical data managers, biostatisticians, and medical writers. Our goal is to provide a comprehensive, well-organized CDISC submission package that ensures a smooth regulatory review process.

Our process includes thorough quality checks at each stage by multiple experts from different departments, making it transparent and easy to quickly identify discrepancies. We foster open communication both within our company and with the client in resolving any issues.

We stay up-to-date with the latest developments in CDISC standards and regulatory requirements. Our team is proactive in implementing updates and changes, ensuring that your data remains current and compliant. We work closely with clients to navigate any transitional phases, providing support and guidance throughout the process.

We prioritize data security and confidentiality throughout our processes. Our company adheres to industry best practices and internal standards of practice to safeguard your sensitive clinical trial data. We employ encryption, access controls, and secure data transfer protocols to protect information at every stage of the submission deliverables creation process, ensuring the integrity and confidentiality of your data.