EN 
DE Our company
Your partner for clinical research and management
Our expertise:
For over three decades, CW-Research & Management GmbH (CW-R&M) has been supporting companies in the pharmaceutical, biotechnology and medical device industries on their way to successful study projects. With our comprehensive expertise as a Contract Research Organization (CRO), we stand for the highest quality, efficiency and reliability.
Our mission:
We are convinced that thoughtful planning, careful implementation and precise analyses form the basis for the success of every clinical study. Our goal is to implement your projects on time and within budget - without compromising on quality and compliance.
Our team
Christian Wolflehner – Managing Director
With decades of experience in clinical research, Mr. Wolflehner stands for in-depth know-how and entrepreneurial foresight. As a certified Quality Lead Auditor, expert in regulatory affairs and data protection officer, he brings excellent expertise to every project.
His career at a glance:
- Studied pharmacy
- Training as an information broker (DIMDI and DataStar pharmaceutical databases)
- Deputy Head of Regulatory Affairs at an Austrian pharmaceutical company (1992–2000)
- Since 1996 working as a clinical monitor, auditor and project manager in the field of clinical studies
- Certified Quality Lead Auditor and Quality Manager in Healthcare (European Organization for Quality, EOQ)
- Certified Quality Manager for Medical Devices and Expert for Regulatory Affairs (Quality Austria)
- Certified Data Protection Officer
- Training as Clinical Trial Specialist (CTS) at the Medical University of Graz
His responsibilities include:
- Management
- Clinical Trial Specialist (CTS)
- Certified Lead Auditor
- Certified Data Protection Officer
- Consulting and lecturing activities
Our team of experienced specialists will ensure that your clinical trials run smoothly and meet the highest standards. Together we will find solutions that exceed your requirements.
Our expertise
- Study planning and preparation: Precise design, regulatory submission and proactive risk management.
- Clinical monitoring: Ongoing monitoring to ensure data quality and regulatory requirements.
- Data management and analyses: Structured collection and well-founded statistical analysis.
- Medical writing: Creation of clear, precise and compliant documents at the highest level.
- Audit and quality assurance: Continuous review to optimize processes and results.
Our values
Quality and precision
➤ Your projects deserve the utmost care. Our certified quality management system (EN ISO 9001) and our experienced team ensure excellent results.
Efficiency and adherence to deadlines
➤ From planning to evaluation – we ensure that your studies are completed without delays and within budget.
Innovative solutions
➤ Every project is unique. We respond to your individual requirements with tailor-made approaches.
Reliability and transparency
➤ Our way of working is based on clear communication and a partnership approach so that you always have an overview.
Steps to a successful collaboration:
1.
Contact
Start with a non-binding initial consultation to discuss your requirements and goals.
2.
Kick-off meeting
Together we discuss all relevant requirements, including safety and quality standards, to ensure optimal processes.
3.
Creation of an individual plan
We develop a customized plan that covers all aspects of monitoring and quality assurance.
4.
Project start
With a clear concept, we take over the continuous monitoring and quality assurance of your study – for a smooth process and reliable results.
Your contact person
