Your real-life projects empowered by our tailor-made digital + CRO services.

  • Cost efficient 

  • Agile 

  • High retention

Full-service CRO for real-life studies (ISR/IIR/IST)

with a reliable digital backbone and innovative digital services

 

Preparation

  • Patient association involvement
     

  • Regulatory engineering (CPP, HdH, CNIL)

  • Scientific board management

medical writing

  • Early proposition paper

  • Protocol conception | CRF designin

  • Clinical reports
     

  • Publications

Sites set-up

  • Qualification

  • Recruitment of sites

 

  • Contract management
     

  • Set-up visits (online and on-site)
     

  • Project-tailored inclusion-portal

StatisticS

  • Statistics plan | Data management

  • Biostatistics (1) | Interim & final reports

  • Inclusion benchmarks

 

  • SNDS paired analysis

 

  • SAS, R, Tableau, PHP generated, etc.

(1) in partnership with Exystat for advanced bniostatistics

  • Project management | Dashboards 
     

  • Inclusion F/U calls | Newsletters

  • Remote monitoring  | Data validation

  • Quality control on-site visits | RBM
     

  • Pharmacovigilance services (2) 

(2) In partnership with vendors

Data input

  • Secured hosting | Objects data model

  • Clinical XML for eCRF and ePRO

  • Form testing by patients (4) | Patient assist.

  • On-site data entry

 

  • SNDS integration (National healthcare system claims databases)

(4) In association with sociologists and major patient associations.

 

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.

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.

DaRQ Monitoring

Data-driven | Risk based | Quality by design

 

In-house team of augmented CRAs

Sanoïa's FTE CRAs are experienced professionals, equipped with digital tools

Centralized decisions based on data-driven monitoring, including patient level data, site level performance and site monitoring recommandations

Data Analytics aligned to CRA daily objectives

Project-tailored dashboards provide insights to perform tight monitoring in real time

Surveillance including analytics such as data visualization, statistical models and alerts

Risk-based Monitoring powered by data stack

Fully automated data stack allows continuous analysis to identifiy data density gap and potential risk practices

 ​

Risk profiling to include the identification and prioritization of risks and mitigation plan

Team tools for site personalized follow-up

Agile information platform allowing to reward inclusion effort the day after and a personalized follow-up by one dedicated CRA with a team support, always one-click away

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Issue management for recording issues and taking action

CONTACTs

e-Health Services SAS

France

cro@sanoia.com

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Affiliations

AFCROs

(French Clinical Research Association)

Sanoïa is an agile Contract Research Organization for tailor-made Real-Life studies.