We are a next-generation Clinical Research Training Institute delivering industry-aligned, practical, and regulatory-compliant education for careers in pharmaceuticals, biotechnology, medical devices, and CROs. Programs are designed in line with ICH-GCP, EU CTR 536/2014, FDA, and global best practices.
A dedicated clinical research education and professional development institute committed to nurturing the next generation of clinical research professionals.
Focus areas: Practical understanding of trials • Regulatory & ethical compliance • Skill-based learning.
Led by a senior clinical research industry expert with 15+ years of global experience across clinical research, clinical data management, and regulatory-compliant trial operations.
Mission: Equip learners with practical skills, regulatory knowledge, and ethical foundations.
Foundations, regulations, stakeholders, planning, documentation, start-up, monitoring, compliance and quality.
Data integrity, DMP, CRF, EDC, edit checks, discrepancies, coding, reports, audit trail and database lock.
PV principles, regulations, case processing, safety reporting, signal detection, risk management and inspections.
SAS fundamentals, reading data, imports/exports, procedures, SQL, macros and ODS.
CDISC overview, SDTM/ADaM, dataset specs, XPT, TFLs, validation and define.xml basics.
Interactive instructor-led classes with Q&A.
Case discussions and real-world workflows.
Reinforcement modules, recordings, study material and references.
Yes, all programs are aligned with ICH-GCP and major global regulatory frameworks.
Yes, certificates are awarded upon successful completion of the program.
All trainings are delivered through 100% online, instructor-led sessions. Learners can attend live classes from anywhere using a laptop or mobile device.
📍 Heerstrasse 396, 13593, Berlin, Germany
