Your real-life projects empowered by our tailor-made digital + CRO services.
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Cost efficient
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Agile
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High retention
Full-service CRO for real-life studies (ISR/IIR/IST)
with a reliable digital backbone and innovative digital services
Preparation
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Position paper designing
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Protocol development
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CRF designing
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ISR/IIR/IST project management
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Regulatory submissions (CPP, CNOM, INDS, CNIL)
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Scientific board management
SET-UP of INVESTIGATORS
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Recruitment of sites
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Contract management
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Set-up visits (online and on-site)
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Project-tailored investigator quick-inclusion-portal
Data collection
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eCRF and ePRO set-up on private platform
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On-site data entry
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SNDS integration (National healthcare system claims databases)
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Form testing (1)
(1) In association with sociologists and major patient associations, Sanoïa provides patient form optimization and patient acceptance testing services.
MONITORING
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Project management
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CTMS with real time dashboards
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Inclusion follow-up calls
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Newsletters to investigators
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Remote monitoring
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Data validation
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Quality control on-site visits
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Pharmacovigilance services (2)
(2) In partnership with a contract safety surveillance organisation (CSO) according to the client's needs.
StatisticS
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Statistical plan writing
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Data management
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Biostatistics (3)
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Interim and final study reports
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Monthly regional benchmarks (inclusion period)
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SNDS co-analysis
(National healthcare system
claims databases)
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Tool agnostic: SAAS,
R, Tableau, PHP
generated, etc.
(3) in partnership: big data and machine learning services.
How to be digital in a real-life study?
An e-cohort is not just an implementation option.
Digital native Protocol
At Sanoïa we continuously monitor our projects in order to capitalize on best practices in patient data collection.
Our team, coached by a medical director and a digital expert, can assist with or carry out your protocol development, with a data collection plan that will be reliable and efficient on a long-term perspective.
Every disease or medical area is different, therefore, patients and investigators might have different acceptance levels with respect to the data collection burden.
As for eCRF and ePRO, which present an important part of the digitalisation of your trial, we conduct patient (with the support of patient associations) and/or investigator « live tests » to optimize them. Upon request of the sponsor, we can provide the scientific board with these feedbacks in an iterative perspective.
Tight Monitoring
An e-cohort (often) requires inclusions and data collection by investigators.
Each investigator site is different.
In addition to regular investigator support services (email or phone), our central clinical research associate (CRA) team is using real-time dashboards to detect potential issues at an early stage which enables us to react faster.
In an agile way, we can either make the tools directly available, so that investigator site CRAs input the data and monitor their data collection efforts themselves, or we have our own CRAs available to visit the sites and conduct data-capture missions on request. This does not constitute a definitive decision and we can allocate our CRAs to a site during a temporary period “on-demand”.
Patient assistanCE
In an e-cohort, even with the best emails or text messages, a human “hello” is required from time to time.
On top of advanced digital routing services assuring that our digital messages are well received, our patient assistant associates use predictive tools to detect their patients’ burdens and contact them to re-motivate them if necessary (our employees are trained in patient dialog techniques).
Direct-to-patient contact is a necessary measure to maximise patient retention. In order to optimize costs for our customers, we can operate both —with regard to a full service— the opening of the site and the patient support. In the course of a set-up visit we put an effort into training investigators well (even workshops on the digital stack) in order to give them the right arguments to motivate their patients in an efficient way and reduce the required patient support.
Sanoïa in a few words
Sanoïa is an agile contract research organization for innovative real-life studies
We are the first "digital CRO" combining patient experience, digital expertise and full-service CRO in an agile mode.
Sanoïa's solutions close the gap between the real life of patients and the clinical research objectives of its clients: sponsors of real-life studies, real world data (RWD) projects, non-interventional studies (NIS) projects in France and international.
Hybrid Sanoïa e-cohorts combine —according to the needs of each project— ergonomic electronic case report forms (eCRFs), patient-reported outcome (PRO) data, via internet or mobile applications, data from connected objects with big data, and analyses from the national healthcare system claims databases (SNDS).
Historically, we at Sanoïa also conduct our own published studies about innovation from information and communications technologies (ICTs) in clinical research and routine care: the impact of e-health solutions on the physician relationship in real life, the contribution of machine learning technologies to data from connected objects, etc.
Sanoïa's data services rely on an ISO 27001-certified health data hosting provider (HADS in French).
