High-Demand Roles
Clinical Data Manager, Clinical Data Coordinator, Data Validator, CDM Specialist.
CDM is the foundational process in clinical research, ensuring data integrity from case report forms (CRFs) to final statistical analysis. Mastery of CDM is crucial for documentation & compliance with global regulatory bodies (like FDA).
Our training focuses on the practical application of industry tools, bridging the gap between theoretical knowledge and real-world experience.
Phases of CDM, Data Flow, essential roles, and the principles of regulatory compliance and data standards.
Designing Case Report Forms (CRFs), database creation, Data Validation Plan (DVP) development, and annotation of CRFs.
Data entry, query generation and resolution, discrepancy management, medical dictionary coding, and external data reconciliation.
Hands-on practice and application of leading Clinical Trial Data systems, including Oracle Clinical, Medidata Rave, and Inform.
Understanding ICH-GCP guidelines, audit trails, database lock procedures, and final archival for submission.
The main objective is to train students to efficiently and accurately handle clinical trial data, ensuring its quality and integrity for final analysis and regulatory submission.
A technical background is not mandatory. While the role uses software, it is primarily focused on process, data quality, and domain knowledge. Our course covers the required system navigation (Oracle Clinical, Rave).
Yes, our training includes hands-on exposure and application practice using leading platforms for handling clinical trial data such as Oracle Clinical, Rave, and Inform.
Stansys is a globally recognized Company (Training Division) since 2008. Your certification, coupled with our 100% Job Assistance, significantly increases your employability in high-compliance roles.
We offer both. You can choose from our traditional Classroom Training or flexible On-line Training solutions to suit your flexible schedule.
Yes, they are complementary. CDM ensures the data is clean and ready, and Clinical SAS takes that clean data for statistical analysis. Mastery of both makes you a highly valuable asset in the Clinical/Pharma domain.