CASE STUDIES

Demonstrate the effect of a drug on blood pressure and attention in farm animals

Identify, set up and synchronize continuous data acquisition systems (animal position, heart rate, EEG, etc.)

Perform the data management for the study, clean up the database, and turn continuous parameters into clinical scores

Analyze sensor data and clinical data (signal processing, descriptive analyses, statistical models, etc.)

Additional information

We can offer services to identify, test and set up sensors, biosensors and connected objects for veterinary or human studies, to develop new clinical scores (and demonstrate their scientific relevance), or to use these tools to enhance studies and improve models, identify weak signals, etc.

Set up, organize and lead a Phase II clinical study

Participation in discussions before study launch, writing study documents: synopsis, protocol, information note, etc.

Management of relationships with the authorities, recruitment and contractual management of clinical investigators, set-up of the eCRF (Ennov Clinsight)

Monitoring of study sites, set-up of an online dashboard showing the progress of recruitment (number of patients by site, budgets, etc.) and presenting descriptive results of clinical and centralized laboratory data

Data management and statistical analyses for the study, in compliance with CDISC standards

Writing the clinical report in ICH format, and writing a scientific publication

Additional information

The support of our Soladis Statistics and Soladis Clinical Studies teams, combining medical and analytical expertise, enables us to satisfy various demands from clients in the pharma, medical devices, food processing and cosmetics industries. These include: supervision of a full study or specific tasks: medical consulting, synopsis writing, DM monitoring report, statistical analysis of study data, site monitoring, participation in DMC/DSMB, etc.

Identify the sources of variability in a process in order to improve it

Definition of a manufacturing process according to the Lean Six Sigma method (DMAIC)

Study of the available data and identification of non-instrumented parameters to be collected in order to enhance the production database.

Identification and implementation of sensors to collect new information on the manufacturing process.

Data collection, clean-up and statistical analyses (descriptive analyses, multidimensional analyses, PLS regression construction, etc.)

Writing the study report highlighting the sources of process variability, and identifying recommendations for improvement

Additional information

We regularly have to support our clients with industrial issues relating to quality: defining sampling plans, programming statistical models to understand the process and identify sources of variability, setting up control charts etc.

Identification and recruitment of study subjects

Identification of social networks and web forums dedicated to pet animals and the pathology for investigation

Programming of the algorithms to scrape/collect comments/data from those sources

Set-up of Soladis’ CWI® (Customer Web Insight) tool with expected keywords in order to identify diseased animals’ owners

Contact lists of eligible animals’ owners

Initial contact with owners targeted for recruitment

Additional information

Our CWI® tool has been built to identify trending topics of interest on the web and social networks, to measure public opinion quantitatively and qualitatively , to study the impact of communication campaigns, to highlight KOLs, brand promoters and detractors, etc., and to sum up all of this information on dashboards with simple indicators.

Audit of analytical routines, and training sessions specifically on the use of statistics

One-day intervention on client site to understand the context and analytic needs of its laboratory and production teams. Study of analytical habits regarding the use of statistical methods.

Writing of an audit report; proposition of an adapted training program.

Construction of a tailor-made training with clients’ cases/data/software; delivery of the training session.

Post-training support with consulting, report/analysis review…

Additional information

We are a Datadock-certified Training Center, and our programs are eligible for financing by OPCAs (joint commissions for collective training). The “Training + support” option is particularly appreciated by trainees, as they can contact their trainer for help with their first steps after the training. The trainer can provide reminders of some of the theory; give advice, or review code or reports. The trainee’s confidence gradually increases and they gain more independence in their everyday operations.

Set up an autonomous system to manage routine surveys (emailing, receipt, consistency checking, data processing, online reporting)

Set-up of a platform, and implementation of specific surveys for different types of members with emailing at specific intervals; creation of a unique identification system for members to prevent duplicate entries

Set-up of control scripts for consistency and data clean-up

Implementation of a dashboard summarizing all results with tables and graphs

Additional information

We are able to set up automated algorithms to import multi-source data, analyze these data with machine learning methods, and present the result in different ways: dynamic report with SAS Visual Analytics or R-shiny, mobile application, chatbot, etc.