We are your competent experts for the various challenges that you face during the development of your projects.
We have in-depth experience in drug development und medical devices and can guide you through the complex development requirements.
Smart, Agile, Experienced
We are dedicated to assist you with the development of your products with a single, unified vision: the faster the clinical development stage is accomplished, the quicker novel treatments reach those who need them – the patients.
Our expert teams work closely with sponsors to tailor the best solution for each project and to deliver clinical trials to the highest quality across the EU, with capabilities reaching into the US and Asia.
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At Qbex Clinical we are highly experienced at dealing with regulatory bodies and ethics committees, having forged strong and lasting relationships with several institutional bodies. We are experts in skillfully navigating the requirements for the preparation and submission of trials for ethical and regulatory consideration in the shortest possible time frames.
Development Program and Protocol design
Our experts are highly skilled in collaborating with sponsors to develop customized programs and protocols that meet regulatory and sponsor requirements. We support your clinical and therapeutic area to ensure that all aspects of protocol design are addressed. Our scientific leaders are experts at developing protocol designs and trial implementation strategies that are efficient, cost effective and customized to the unique clinical and trial environment of the various regions in which we work.
Feasibility Studies and Site Selection
Selecting the right region, country and site is perhaps one of the key challenges to the success of clinical trials and sometimes crucial to success
For these reasons, Qbex implemented a 3-STEP-Feasibility approach.
1 Step – Early Indication Feasiblilty
2 Step – Protocol Feasibility
3 Step – Site Feasibility
While we are working closely with our clients, Qbex identifies those geographic areas well known for their prevalence of the targeted indication. All regulatory requirements are then reviewed and timelines developed for each country to ensure that regulatory approvals will permit adherence to the project timelines. Our Data driven feasibility assessment will improve the probability of getting the right sites to improve the recruitment performance. It allows for informed decision making for our clients where all available information is taken into consideration.
A well-managed project is one whose team members are well trained and which is carried out with tight oversight per contract and within budget. Issues must be discovered early and addressed: success lies in careful thinking and up-front planning, as well as change management and all key aspects of your project: the clinical trial.
Our project managers the experience and skills required to proactively plan all key events, coordinate all stakeholders and lead an international team in complex trial settings.
Clinical Monitoring and Site Management
Qbex CRAs perform all activities related to pre-trial/qualification visits, initiation visits, interim monitoring visits, and closeout visits, ensuring compliance to the protocol and all regulatory requirements. The CRA Team also maintain strong and constructive relationships with investigative sites to ensure successful trial progress.
Our CRAs can strategically located to ensure local knowledge, language, and cultural understanding, as well as to reduce travel costs and increase efficiency.
Data Management and Biostatistics
We are able to manage all Data Management and Biostatistics aspects of your projects from protocol development and sample size calculation to final study report. Our experience allows us to identify the most efficient and cost-effective approach to completing your clinical trial.
Qbex Clinical uses state-of-the-art IT Systems to speed up the data analysis process. Our Data Management team has built up extensive hands-on experience with several data management systems, including Medidata RAVE, OmiComm TrailMaster, iMedNet,... . As a result and similar to all other services, Qbex is able to offer the flexibility that our clients desire and require.
QbEx Clinical provides the complete panel of pharmacovigilance services. At the core of our pharmacovigilance processes are patient safety and regulatory compliance. Patient safety narratives are written with input provided by the QbEx Clinical cross-functional teams, who review all available data and information (e.g., pharmacovigilance database, clinical trial database, CIOMS forms, hospital records, case report forms).
Our network of professional medical writers combine medicine, science, and technical writing to deliver accurate documents of highest ethical and scientific standards.
Whatever you need, we have a medical writer to complete with speed, accuracy and professionalism.
Data Quality and adherence to all relevant legislation is at the core of how we work in clinical research.
Qbex provides high-quality and comprehensive Quality Assurance support tailored to your particular project. We ensure that all aspects of your clinical trials are in full compliance with Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) requirements.
We cover all GxP areas: GMP, GCP, GLP as well as medical devices. We can perform audits, on your behalf, of your study centres, your vendors and also special facilities like databases, cell banks, labs and providers of study medication. We offer special expertise in the area of ATMP (Advanced Therapies), blood, plasma, cells and tissue.
OUR PROPRIETORY eTECHNOLOGY
We believe that technological innovation is essential to streamline workflow, enhance decision making, and improve the quality and efficiency of clinical trials.
What is the right IT solution for a clinical project?
Our team of IT experts has built up extensive hands-on experience with several software solutions fully integrated or stand alone and we are able to find „the one“ which fits to your project.
THE In house Solution
Qcom is a fully validated Software Suite to support all Data collection and processing requirements within Clinical Trials.
From feasibility study to final study report, this platform offers many solutions for each stage of the clinical trial. In addition, the new Qcom delivers a wide range of ERP functionalitay, e.g. eTMF funcitonality, Project management tools, Investigator fee handling, ... budget controlling, contract handling as well as budget controlling and contract handling.
Qcom is fully integrated, centrally hosted and browser based. This allows access to the information from common devices, covering all aspects of security.
THE Flex Solution
Our Team of experts is used to work with several „out of the Box“ Software solutions that may be preferred by our clients and we are able to offer the flexibility that our clients require.
According to your needs, we choose the right person for your request. Do you need special expertise? We will provide it.
Hon.Prof. Mag. DDr. Alexander Hönel
Regulatory Expert of Qbex
Dr. Hönel was the head of the Austrian Surveillance Body (Inspectorate) of the Austrian Health Authority from 2004 till 2014. He dealt with and was responsible for Medicinal Products, Medical Devices, drugs, enforcement and vigilance. He was member of the Austrian Medical Devices Advisory Council for the Minister of Health, member of the management board of the PIC/S, EMA expert for GCP and PHV, member of several working groups of the European Commission and is member of the Austrian Anti-Doping Commission NADA. From 1996 till 2004 he worked within the pharmaceutical industry in Drug Development. Since 2014 he is consultnat and Auditor for the pharmaceutical and medical device industry.
His scientific background are university degrees in veterinary medicine, law and politics, as well as Public Health Care (MBA), Medical Law (LL.M.) and Pharma-Management (MSc).
Due to our long lasting international activities we can offer you special experience with a large number of countries and their legal particularities.
You will benefit from QbEx’s comprehensive experience in all stages of product development. QbEx Clinical has a broad range of therapeutic expertise and know-how, with a particular emphasis on Diabetology, Cardiovascular disease, Oncology, Cancer Immunotherapy, Vaccines and a Team with 20 years experience in IITs, especially oncology.
We are here for you every step of the way, offering the full suite of clinical development services. Our unique structure allows you to choose the combination of expertise and services you need, tailored to your requirements.
Partner with us to gain access to our years of experience and our network, reducing your product development time and giving your technology the best chance of success.
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1090 Vienna, Mariannengasse 28/2
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