Clinical Safety

Extensive know-how in safety monitoring of multinational, multicenter studies

GWT - Your partner for optimal safety monitoring in clinical trials since more than 25 years

Our experienced team of clinical safety experts will create a customized concept for allover safety monitoring for your IITs (Investigator Initiated Trial), non-interventional study (NIS) or Post Authorization Safety Study (PASS) in many indications such as diabetes, hematology, oncology, immunotherapy, pneumology and cardiology.

Your benefits at a glance

  • Reliable partner for recording and reporting SAEs and adverse events.
  • Close cooperation with European network of trial sites and CROs.
  • Efficient, transparent communication and early risk identification.
  • Extensive know-how in safety monitoring of multinational, multicenter studies.
  • Structured processes according to current regulatory requirements and guidelines.
Photo; woman with smock in a medical laboratory in front of a screen

Clinical Safety - Reliable, collaborative, efficient: our services to ensure compliance.

Safety management consultancy
Preparation of all safety-relevant documents
Recipient address for safety reports (SAE/SAR) from the test centers (PASS)
Forwarding of safety reports to the MAH/financier
Processing, documentation and follow-up of reports
Assistance with preparation and submission of periodic updated Safety Report
Preparation of SAE lists, compilation of safety data
Data reconciliation between the study databases
Generation of SAE processes in AMG studies
Generation of the annual Safety Reports (DSUR) and other periodic reports

GWT - your expert for successful Clinical Safety and Pharmacovigilance!

Reliable Reporting: Reliable partner for client-specific Safety Management and SAE reporting
Proactive Communication: Efficient communication allows for early risk identification
Compliant Processes: Structured processes impeccably aligned with regulatory requirements

Photo; laboratory technician with a pipette in a laboratory

Effective Clinical Safety with GWT experts

Petra Gerteis

Clinical Safety Specialist

Monica Johanna Gomez Sarmiento

Clinical Project Assistant

Wera Kupetz

Team Leader Clinical Safety

Pharmacovigilance according to ICH-GCP: GWT - Safety & Welfare for Patients in Clinical Trials

GWT: Your expert for pharmacovigilance in clinical trials.

Pharmacovigilance is of central importance in clinical trials, focusing on patient safety and well-being. Our team, together with our partners (CROs and the medical experts), ensures accurate recording and reporting of SAEs and adverse events, early risk identification and compliance with all regulations. With 25+ years of experience and the goal of highest safety for study participants, we support your study according to ICH-GCP guidelines.

Trust our expertise in patient safety, data integrity and individual solutions. Together for the success of your projects.

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Expiry: 30 days
Location: Localstorage
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Expiry: 30 Tage
Location: Localstorage
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Sponsor Oversight
GWT: Your independent sponsor for comprehensive clinical trials

Clinical Project Management
Comprehensive coordination of all aspects of your clinical trial

Clinical Project Administration
Seamless communication and administration of your clinical trial

Clinical Data Management
Ensuring the highest quality and 100% integrity of your clinical data

Clinical Quality Management
Highest quality standards in the supervision of your clinical trial

GWT StudyDesigner

Transform your study design with GWT StudyDesigner - Real-time interactive design and expert advice for your clinical research!

Project Administration
Efficient administrative implementation of industrial projects

Contract Management
Individual consulting for legally compliant transfer projects

Financial Management
Ensuring and carrying out correct financial transactions

Startup Backoffice

Turn your ideas into action - supported by GWT's comprehensive business platform.

Are you ready to become entrepreneurial and focus on your product?

Take on the role of project manager and act like an entrepreneur while we support you

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