Qbex offers numerous services to manage all stages of a clinical study.
We support our Customers with the utmost flexibility by managing the entire process and controlling all the research or applying specific services to a single step. Our highly skilled staff follows the Sponsor from planning initial activities, throughout data collection, to the drafting of the final report.
At Qbex we have extensive experience in dealing with regulatory authorities and ethics committees, having forged strong and lasting relationships with several institutional bodies. We are experts in managing the requirements for the preparation and submission of trials for ethical and regulatory consideration in the shortest possible time.
Qbex CRAs perform all activities related to pre-trial/qualification visits, initiation visits, interim monitoring visits, and closeout visits, ensuring compliance with the protocol and all regulatory requirements. The CRA team also maintains strong and constructive relationships with study sites to ensure successful trial progress.
Our CRAs can be strategically located to ensure local knowledge, language, and cultural understanding, as well as to reduce travel costs and increase efficiency.
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.
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.
Qbex 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 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 experts are highly qualified 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 in developing protocol designs and trial implementation strategies that are efficient, cost effective and tailored to the unique clinical and trial environment of the various regions in which we operate.
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 find the most efficient and cost-effective approach to completing your clinical trial.
Qbex uses state-of-the-art IT systems to accelerate the data analysis process. Our Data Management team has built up extensive hands-on experience with various data management systems, including Medidata RAVE, OmiComm TrialMaster, iMedNet,... . As a result and as with all other services, Qbex is able to offer the flexibility that our clients want and demand.
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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.