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/closed area) › Upload data/information as defined in the charter › Management of board/committee meetings (facilitator role)
Presentations
› How to avoid GCP inspection findings? (e.g., during Investigator Meetings) › Investigator Initiated Trials.
Smart Training® ist kompetentes Training im kleinen Kreis (Small groups around the table). Die sehr begrenzte Teilnehmerzahl garantiert das Eingehen auf Ihre Fragen sowie ausreichend Zeit zur Diskussion der Seminarthemen. Die Seminare haben somit für Sie einen optimalen Nutzen.
Die Seminare werden ständig auf den neuesten Stand gebracht und spiegeln zu jeder Zeit die aktuelle Fachdiskussion zum jeweiligen Thema wider.
Bei Trainingsende erhalten Sie ein Teilnahmezertifikat.
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