Clinical Operations

A FEW WORDS…

The management of your clinical and real-life studies in a paper-free environment: feasibility studies, submissions, monitoring.

  • Feasibility studies and initiation of your trials (IS II/III and NIS)
  • Regulatory submission & support
  • Project management
  • Monitoring/risk based monitoring
  • Local teams

 

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OUR DELIVERY METHODS

CONSULTING

PLATFORMS

PROJECTS

AREAS OF EXPERTISE

AIXIAL takes care of the planning and accurate management of your studies to ensure the coherence and the success of entrusted projects. Transparency to our clients, managerial documentation and clear communication, dynamic risk management, and accurate and effective escalations of information are our priorities.

For the benefit of its customers, AIXIAL has consciously opted for easy project communication. Our customers can, at any time, get an immediate global overview of their projects through our Clinical Trial Management System and our electronic Trial Master File, both remotely accessible.

Our quality standards highlight a centralised management for our “Full Service” studies, which ensures smooth exchange of information between AIXIAL, and other structures and expert centres involved in our projects.

Our project managers are used to oversight monitoring activities through the operational support of our Lead CRAs. By means of a clear organisational structure and direct lines of communication, you are assured of an AIXIAL project team that is thoroughly acquainted with the protocol, specific features and therapeutic area of the study.

At AIXIAL, we develop advanced risk approach strategies for our clients, and our project managers are in constant contact with our CRA teams to ensure that these are effectively applied in the operational context.

Our CRAs teams are assigned 3 major priorities:

  • ensure the quality of the collected data
  • ensure compliance with local and international regulations
  • maintain close and quality contact with the study centres

That’s why we attach such great importance to involving local and experienced CRAs in the projects entrusted to us. We train them continuously on the major issues linked to patient safety and sensitive data protection.

As part of AIXIAL’s highly integrated Risk-Based Monitoring (RBM) strategies, our CRAs can visit the trial centres in addition of remotely monitor a large number of critical items, such as recruitment, training, administrative quality or vigilance in the participating centres. Whether monitoring is performed locally at the centre or remotely, our CRAs are required to follow clear, accurate and carefully designed reporting procedures on the situation of the centres.

Our vision of the RBM involves the closest possible monitoring of the study centres over time, an anticipation of risks and a proactive initiation of corrective/preventive actions. That’s why at AIXIAL, we have developed a specific tool for risk monitoring and RBM-related actions. This tool, linked to the RDC, is adapted to each study via specific indicators, and allows ongoing identification of a risk variation related to the protocol, or to a specific country or centre participating in our studies.

To facilitate the follow-up of the actions of our CRAs, our advanced CTMS supports and tracks a straightforward remote monitoring of problems, deviations and CAPAs performed by our teams. The reports of our CRAs are accessible at any time, by simple connection to the tool.

Because document management is an essential aspect of our work and reflects the quality of the project as a whole, our e-TMF facilitates simple, continuous and secure remote access to all the essential documents for the study.

In support of the project manager, our AIXIAL Clinical Trial Assistants (CTAs) are responsible for the completeness and quality of our e-TMF, and through regular structured quality controls we ensure that this quality is maintained throughout the whole study duration.

Our e-TMF architecture implements the DIA recommendations, regarded as the gold standard in this field, and all of our electronic tools comply with the 21 CFR part 11 rules as recommended by the FDA.

On the centre side, we offer an e-ISF solution that is directly connected to our e-TMF and allows direct, secure, instant and reliable access by the personnel of the centres to the documents assigned to them.

To ensure clear and continuous information, our CTMs are trained to respond to any requests from project team members and our clients for documentation related to our studies.

AIXIAL has an extensive experience in handling submissions to the competent authorities and ethics committees in European countries.

For us, regulatory submission is first and foremost a collaborative effort between our global and local experts which aims at meeting the requirements of international, European and national regulations.

In each country, we ensure the compliance of the files with the local requirements related to personal data protection, import/export authorisations, and national adaptations. At AIXIAL, each file is systematically reviewed twice to ensure its completeness.

Throughout the study, our regulatory experts are fully involved in the review of serious deviations and amendments brought to the research projects.

Our goal is to assure our clients of continuous regulatory support, and optimise the chances of a successful project conclusion.

In order to offer the best possible service at the most economical cost, AIXIAL has chosen to work with validated IT tools that optimise the accuracy, frequency and quality of monitoring throughout the study.

CTMS

The CTMS used by AIXIAL allows the Sponsor and each member of the project team to remotely obtain a clear, continuous and exhaustive overview of the clinical project status. In a few clicks all stakeholders can access the authorisation, initiation and recruitment statuses and the level of risk detected for each investigating centre. This tool also supports secure access to monitoring reports, ongoing actions and payment status of the centres throughout the whole study duration.

e-TMF

AIXIAL has opted to work with e-TMF. This tool provides at any time a secure access to the whole essential documentation for the trial. It also facilitates the simple and secure management of the review and validation cycles for the study documents.

We also offer the possibility of linking our e-TMF with our e-ISF solution (electronic Investigator Site File), which reduces the shipment costs to the sites, as well as optimising the tracking of acknowledgements of receipt and signatures by the investigators.

Risk Tracking Tool

In order to enable continuous and transparent monitoring of the study-related risks, AIXIAL has developed its own Risk Tracking Tool. With this tool, interfaced with the RDC from study initiation, risks can be effectively monitored and appropriate mitigation actions can be applied at 3 levels: centre, country and protocol levels. In particular, this tool allows regular extraction of reports sent to the project managers and to the Sponsor in order to provide a clear vision of the ground reality.

e-Sign

Our electronic signature tool ensures excellent response rates by potential sites during the feasibility phase and proven responsiveness for administrative procedures involving investigators. It also facilitates the completion by investigators of electronic questionnaires during the project.

Our priorities

Transparency of data Patient safety Deadlines respect
SPONTANEOUS APPLICATION
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SPONTANEOUS APPLICATION








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