Our Tasks and Goals
Our goal is to ensure lasting customer satisfaction by providing customized services that satisfy the highest technical standards, while being cost-effective, in the following professional areas:
- Project management and monitoring of clinical trials according to the Austrian drug law (AMG) or Austrian medical device law (MPG)
- Project management and monitoring of non-interventional studies (NIS) and Post Marketing Observational Studies (PMOS)
- Planning, set-up, and evaluation of clinical trials and non-interventional studies
- eCRF-development and datamanagement by using a user-friendly and company-internal eCRF
- Management consulting and expert support (seminars for principal investigators and CRAs:GCP, informed consent process, practical monitoring including coaching and start-up assistance, essential documents, SOP trainings
- Conducting audits at clinical trial sites, at CROs or at our clients (pharmaceutical companies)
- Pharmacovigilance and SUSAR-reporting
- Recruitment Services
- Medical Writing
Our management system allows us to maintain a quality management strategy that facilitates continued quality improvement and error prevention.
Therefore our mission is:
- to provide our clients and stakeholder with a transparent scope of service/performance report
- to ensure that our competent staff maintain close contact with the client throughout the project development phase
- to ensure optimal project development by providing transparency and clear instructions
- to continuously strengthen our competence and expertise
- to ensure that the engaged subcontractors uphold our high standards
This means that our team work will be marked by the following:
- applying and sharing the gained expertise
- having common goals as a team
- fast and direct dealing with and forwarding of information considering data security
- contributing to friendly business practices by open communication
- dealing with temporal and professional requirements in a flexible manner
- ….all that by having fun and achieving job satisfaction and happiness!
By constantly optimizing all processes as well as our management system we aim at providing improved services in the long run. It is our duty to make our professional services compliant with the statutory provisions and licensing requirements.
Every employee is informed of this policy which stands at the company’s forefront at the beginning of their employment and at least once a year.
Clients and Investigators
The company’s objective is to ensure long-term success rather than gaining short-term profit. For this reason we aim to be a reliable partner to our clients. We will do our best to meet the requirements resulting from european regulations and austrian law (AMG & MPG, data protection act), ICH-GCP and the sponsor’s standard operating procedures.
With regard to our main business area, the monitoring and project management of clinical trials, and as the link between sponsor and site we would like to convince the investigators as a potential client of the pharmaceutical company with our professional & social skills. However, in doing so, we will never fail to fully honor our legal and contractual obligations. Any emerging conflicts will be discussed as soon as possible with our clients.
Our invoices are issued in a timely fashion in line with the legal requirements. We will do our best to be sensitive to our clients’ requests. Since our company may offer services to many clients concurrently, it is important to avoid possible conflicts of interest from the very beginning. We offer our guarantees that the same staff member will never form contractual relationship with 2 clients to offer services to the same study doctor in clinical studies for the same field of indication.
Partner and contractors/vendors
We want to be a trustworthy business partner to our partners and contractors. The work performed will be paid in a timely manner right on agreed-upon terms. When we call for tenders, the lowest bid is not our only selection criterion, but rather we tend to pay specific attention to factors such as proven competence, prior collaboration, adherence to schedule and reliability.
Our company requires employees who possess the necessary skills and knowledge to help the company craft its competitive edge and stay on top in the market. It goes without saying that a company is judged by its operational performance and generation of results, and one must work hard to achieve recognition. Mutual trust and respect are indispensable features of any social interaction, and a business setting is no exception to that. Hence, our employees are treated in a respectful manner and are rewarded for good work. While provided with clear instructions, they are offered the maximum possible freedom to achieve their goals.
Within the scope of our services the primary objective of our activities is to safeguard the well-being of the enrolled study subjects as well as their rights with respect to confidentiality and data protection & safety. Our company follows a non-discriminatory policy, ensuring equal opportunity for women. Our economic situation allowing, we try our best to offer apprenticeship opportunities to young people who learn and perfect their trade on the job; we regard it as our duty and responsibility to the society.
We offer guarantees that our company and its employees act in accordance with the relevant legal requirements. Violations will not be tolerated and will be subject to appropriate sanctions.