Clinical Data Science

A team of specialists committed to the success of our clients’ projects:

• The project managers embody responsibility for the studies and are the primary points of contact with our clients.
• We commit to prioritizing the quality of our deliverables. All of our standard operating procedures are designed to ensure the safety and security of our production. We are audited quarterly by our clients in addition to internal audits.
• Different partners affirm their confidence in us by maintaining long-term contracts (pharmaceutical industry, biotechnology, institutional …).
• We work in all therapeutic areas; cardiology, oncology, metabolism, ophthalmology, medical devices …
• We carry out phase studies for the purpose of submission, epidemiological studies, ATUs/RTUs, real life studies.

The Data Management team conducts cross-functional studies within Aixial:

• With Clinical Operations (monitoring, detection of protocol violations, automatic connection with CTMS, risk-based monitoring …),
• The pharmacovigilance department (registration of AE alerts).

In order to ensure the quality of our production and the rapidity of our responses, Aixial has invested in high-performance EDC tool.

• An internally designed and developed EDC.
• Unmatched experience accumulated since the first study conducted in 1998.
• A functional range allowing the implementation of all the types of study (phase study, NIS, ATU …) and integrating a randomisation module.
• Rapid implementation; from 3 weeks to 3 months depending on the studies, with commitment on deadlines.
• A development team to adjust the operational scope to optimise the study:
  • Integration of laboratory, ECG, imaging data
  • Digitalisation of data (example: measurement of treatment compliance …)
  • Production of customised reports …

We take up your challenges in relation to the submission of clinical data

Today, the standards developed by the CDISC® are a requirement for the submission of results to the FDA: SDTM and ADaM. These allow the FDA to easily integrate incoming data into its analysis tools, and have thus become an indispensable prerequisite for the laboratory to access its target market.

We support you in integrating SDTM/ADaM standards, maximising your productivity and assuring the traceability of information to avoid the loss or corruption of information during the data conversion phase.

AIXIAL GROUP: an expert team in CDISC® standards

Our CDISC® programming team will accompany you throughout your study with the following services:

• Advice and support for the implementation of these standards in relation to your existing processes.
• Data migration and creation of SDTM/ADaM package
• Ensure optimal traceability of old studies for high quality submission packages.

Thanks to recognised expertise and a unique quality of service AIXIAL GROUP offers efficient conversion to CDISC® models: Mapping to SDTM/ADaM standards, annotated CRFs, generation of .xpt files from SDTM/ADaM definitions, creation of define.xml files, validation of data and define files (Pinnacle 21®), creation of “reviewer’s guide”, pool of studies in the context of ISS/ISE.

Know-how at the service of strategic projects in line with the expectations of the health authorities.

We support your project right from initial conception of the study: a dedicated team – medical writer, senior statistician and clinical project manager – works in close collaboration to write the protocol according to your (or our) template.

Our senior statisticians advise you and provide their expertise in determining the sample size and writing the statistical methodology section of the protocol. Their global review of the protocol ensures consistency between evaluation criteria, parameters collected and statistical methodology. They suggest the most appropriate randomisation scheme to the design of the study and generate the randomisation list, implemented later in our e-crf by our EDC developers.

Our team of statisticians develops the statistical analysis plan according to your (or our) template in accordance with the statistical guidelines (ICH, points to consider …). They focus on proposing the ad hoc methodology, alternative methods and sensitivity analyses, as well as a clear definition of derived variables.

Together with data managers, they are involved in data quality monitoring, signal detection, fraud, protocol deviation research and lead data review and surveillance meetings.

They program analyses and design statistical models, provide advice and expertise for data exploitation, presentation and interpretation of results.

Our medical writers develop the study report according to the ICH E3 guidelines, according to your or our template, as well as the scientific communication supports. The support of our statisticians as co-author or reviewer ensures the conformity of clinical interpretations with statistical results.

Focused on the quality of deliverables and deadlines, highly qualified in SAS programming, our statistical team relies on a standard SAS macros library that is validated and developed in-house. Your projects are supervised by experienced statisticians, responsible for quality control of all deliverables, in collaboration with one or more statistical programmers.

Aixial has created its own EDC tool (Electronic Data Capture, e-crf), which it develops, maintains and hosts in-house.

It is a web application consisting of two components, e-builder for the creation of ‘e-crf’ and e-crf for the collection of biomedical data.

e-builder: enables our partners to autonomously create their own e-crf’s

e-builder is a web-based solution allowing remote access from the operator’s workstation. No specific installation is required locally; several teams can work simultaneously on different studies. Access is secured according to sponsor or study group.

With this web application a study can be set up from a workstation with an internet connection. The solution covers a large range of functions and covers in particular:

• the declaration of metadata,
• the design of forms,
• the implementation of controls online,
• document production/management,
• the creation of libraries of standards.

e-crf with all its specialist interfaces enables the acquisition, monitoring and management of clinical data.

The e-crf solution proposed by Aixial Group is an online solution, which does not require any specific installation on the user’s computer. All that is needed to access the solution is an internet connection and a standard browser.
The application can be run interchangeably on a computer, a tablet or a smartphone.

As standard, e-crf offers all the functional interfaces for the processing of a clinical study:

• Investigator
• Clinical research associate
• Data manager
• Project lead

e-crf is rapidly available. An extensive library of controls and standards makes the collection of data reliable and efficient.

In addition to the 4 previous modules, patients have access to a dedicated interface via e-crf or an e-pro allowing them to fill in self-questionnaires and diaries in the local language.

Follow-up tables allow all stakeholders (investigator, CRAs, data manager, project Manager) to follow the data collection and have follow-up reports adapted to their job. They allow rapid evaluation of “to do’s”.

We provide our clients with a team of around fifteen programmers and statisticians dedicated to clinical research in oncology. Over the past ten years, this team has accumulated solid expertise in the oncology field from phase I to phase IV.

We offer our customers a package of off-the-peg statistical solutions. According to your needs our oncology statisticians can help you in:

• writing the statistical part of the protocol that can integrate adaptative designs or Bayesian methods
• authoring the statistical analysis plan
• the design of your databases according to CDISC standards
• management of the blind review
• analysing and modelling your data
• proofreading of the clinical report

We also present your results at conferences or for publications with our expertise in the use of visual tools. For congresses we have the opportunity to develop with a Shiny R package an interactive website for viewing results and make your presentation or poster more attractive. In addition we can create 3D waterfall plots, swimmer plots or any other presentation in line with your needs.

With our experience in supporting the development and implementation of the standard statistical analysis plan in oncology and the resulting tools, we will be delighted to share our expertise in this field with you.