Clinrex Munich

Clinrex was founded in 2004 by Dagmar Chase to offer Quality Management consulting services, training and audits in the area of clinical research/ GCP. Before Clinrex, Dagmar Chase accrued more than two decades of knowledge in the respective fields through starting-up and growing a full service CRO. Dagmar Chase builds on over 30 years of experience when offering her services. Now, as a consultant and trainer, passing on knowledge and experience, is her mission.

GCP/Quality Management Consulting

› Assessment of systems or studies regarding GCP compliance › Inspection preparedness/mock inspections/audits › SOP development/SOP streamlining › GCP gap analyses › Interface sponsor/CRO (CRO selection, interaction and oversight) › Investigator Initiated Trials (IITs)

Training

› Customized in-house training for sponsor companies and CROs › Training for investigators and site personnel › Training Focus: ICH-GCP (R2), EU Clinical Trials Reg. 536/2014, AMG, Non-interventional Studies (NIS), IITs, Project Management/ Working with CROs

DSMB/DMC/Steering Committee

› Member identification/setting up the board/committee › Writing the charter › Setting up an internet platform (open/closedarea)› Uploaddata/information as defined in the charter › Management of board/committee meetings (facilitator role)

Presentat ions

› How to avoid GCP inspection findings? (e.g., during Investigator Meetings) › Investigator Initiated Trials.