Clinical Quality Management for your clinical trial

Welcome to GWT, your expert in Clinical Quality Management!

Based on the experience of the last 25 years, GWT has established a successful and comprehensive quality management system in the field of clinical research. The primary goal of this QM-system is to ensure patient safety and data integrity in the conducted clinical trials. For this purpose, we regularly conduct audits, re-evaluate all necessary processes for the conduct and monitoring of clinical trials and, if necessary, adapt QM-documents such as the quality management and monitoring plan.

Your benefits at a glance

Specialized in IITs, AMG and MPG studies in diverse therapeutic indications.
Extensive experience in multinational, multi-site studies.
European trial site network for comprehensive research support.
Expert team for Quality Management ensures highest quality standards in study monitoring.
Process and workflow optimization in accordance with applicable regulations and guidelines.

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Clinical Quality Management - specialization, proficiency, optimization: Our services for improving clinical quality.

⌈ Supervision of the clinical study and its QM and RM processes
⌈ Performance of internal audits
⌈ Supervision of external audits
⌈ Administration and updating of study-relevant QM and RM documents
⌈ Qualification of study relevant vendors
⌈ Implementation of the DIN ISO 9100 and ISO 31000 standards
⌈ Implementation of clinical regulations (ICH-GCP, ISO DIN, AMG)

GWT - your expert for successful Clinical Quality Management!

⌈ Therapeutic Specialization: Specialized in IITs, ICH-GCP, EU 536/2014, MDR studies across various therapeutic indications
⌈ Multinational Proficiency: Extensive experience in clinical quality management of multinational, multicenter studies
⌈ Optimized Processes: Process optimization conducted per stringent regulations (ICH-GCP, ISO DIN, AMG)

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Effective clinical quality management with GWT experts

Martin Puttrich

Teamleitung Clinical Quality Management und Prozessdigitalisierung

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Phone:
+49 351 25933 193

Email:
martin.puttrich@g-wt.de

GWT: GCP Guideline Compliant Clinical Quality Management - QM Documents, Audit & Inspection Support for First Class Study Quality

GWT: Your expert for Clinical Quality Management - Ensuring patient safety and data integrity through GCP-compliant QM documents, audits and inspections. Trust in over 25 years of experience in clinical research!

Clinical Study Promotion

GWT offers a holistic approach to increase the visibility of your studies, effectively identify and recruit study sites and participants. To this end, GWT offers evaluation of suitable study sites, implementation of effective patient recruitment strategies, and provision of a multinational personal contact for smooth operations and optimal results in clinical trials.

Clinical Project Administration

Our team of experts and European network ensures excellent administration, structured organization & continuous communication. Successful research goals & improved patient care with GWT as a reliable partner.

Real World Data Sets

Targeted insights for indications such as pulmonary disease, diabetes, cardiovascular disease, and hematologic disease improve clinical trials through real patient data, in-depth analysis of big data, and better understanding of therapeutic approaches.

Preclinical Study Advice

GWT supports you in experiment design, statistical analysis, pharmacology, toxicology, GMP manufacturing, analytics, scientific advice (PEI, BfArM) and scientific writing. Benefit from our expertise in preclinical advice, regulatory requirements (EMA, FDA). We support you in experiment design, statistical analysis, pharmacology, toxicology, GMP manufacturing, analytics, scientific advice (PEI, BfArM) and scientific writing.

Thank you for your interest in our services. We gladly answer your enquiries!

Martin Puttrich

Teamleitung Clinical Quality Management und Prozessdigitalisierung

view profile

Phone:
+49 351 25933 193

Email:
martin.puttrich@g-wt.de

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