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coTrial Associates (Clinical Trial Center)

Welcome to coTrial Associates

Our experienced team can offer you a wide range of clinical trial services to support your Investigator-Initiated Trials (IITs) and other clinical studies.

Our clinical trials support team consists of health care professionals and scientists with considerable international experience in initiating and conducting Phase I-IV clinical trials according to the ethical principles outlined in the Declaration of Helsinki, and consistent with national laws (e.g. AMG, GCP-V) and international standards (ICH-GCP).

coTrial Associates is an excellent alternative to an expensive CRO. Please contact us for a reasonable estimate in covering all your clinical trial needs.

Let our experienced team help you achieve your goals!

coTrial Associates
Ingrid Mutzbauer, Dipl. Biol., Clinical Trials Manager
University Hospital Regensburg
Department of Surgery
Franz-Josef-Strauss-Allee 11
93053 Regensburg, Germany

Tel:   +49 (0) 941 944 6774 or 6736
Fax:   +49 (0) 941 944 6772
E-mail: cotrialassociates@ukr.de
Website: www.cotrialassociates.com

ZKS Partnership

Our group cooperates together with the Center for Clinical Studies (ZKS) at the University Hospital Regensburg as a Central Study Unit to support all of your clinical trial needs.

Areas of Expertise

Start-up Activities/Consulting

• Consultation on IITs and other clinical trials (Phase I-IV)
• Study design and planning according to ICH-GCP guidelines as well as local law (AMG) and international standards
• Feasibility analyses
• Budget planning and tracking
• Site contract negotiation and implementation
• Collection of essential documents
• Obtaining patient insurance

Project Management and Quality Assurance  

• Oversight and management of the complete clinical trial
• Interface to all involved stakeholders
• Proactive and efficient working procedures
• Budget monitoring and supervision (on time-on budget)
• SOP development and maintenance
• Quality Assurance

Regulatory Affairs

• Clinical Trial Applications to ethics committees (ECs) and competent authorities (including internationally)
• Submission of substantial amendments and reports
• Notification to local authorities

Monitoring and Site Management

• Study site initiation visits, regular site monitoring visits and close-out visits in German and English speaking countries (including USA)
• Timely follow-up (visit reports, issue escalation, etc.)
• Training of site staff
• Comprehensive consultation and contact with the sites
• Ensure data quality and adherence to protocol

Pharmacovigilance  

• Patient safety management
• xEVMPD submission and amendment
• SAE management and SUSAR reporting (incl. eSUSAR reporting)
• Medical assessment
• DSUR - Annual Safety Report
• Data Safety Monitoring Board (DSMB) coordination

Data Entry and Data Management

• Data entry
• Central review of entered data
• Data validation
• Query management
• Ensure data integrity

Medical Writing

• Study protocols and amendments
• Patient Information and Informed Consent
• Final Clinical Study Report

Study Site Tasks – Study Nurse Services

• Preparation and coordination of patient visits
• Documentation in (e)CRF
• Drug accountability
• Contact person for CRA

Project Administration and Coordination

• Investigational Medicinal Product (IMP) supervision, monitoring and accountability
• Essential document preparation and tracking
• Development and maintenance of TMF
• Administrative and logistical support, e.g. site payments for patient participation
• Organization of Investigator meetings
• Medical editing by native English speakers
• Preparation for archiving

Our Team

coTrial Associates Team
coTrial Associates Team
Zoom

Major Clinical Trials (selection)

>> Overview of Major Clinical Trials

Links

>> University Hospital Regensburg - Guidelines for Third-Party Funds 2016 (German)


Center for Clinical Studies (ZKS) - University Hospital Regensburg
Contact Person: Tanja Emmer, Study Coordination
Building B3, 3. UG, Offce 0.14
Telephone: +49 (0) 941 944 5629
Telefax: +49 (0) 941 944 4495
E-mail: tanja.emmer@ukr.de
Website: Zentrum für Klinische Studien (ZKS)
Website: ZKS Lotsin für klinische Studien am UKR

Research Coordination, Faculty of Medicine - University Hospital Regensburg
Contact Person: Dr. Ingrid Wanninger
Building ZMK, Office 4.107.3
Telephone: +49 (0) 941 944 5274
Telefax: +49 (0) 941 944 5273
E-mail: ingrid1.wanninger@ukr.de
Website: Forschungskoordination, Fakultät für Medizin

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Last Update: 20.04.2017 | Webmaster
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