FROM REAL-WORLD DATA TO HEALTHCARE INNOVATION

SIGNIFIENCE is a Data-Driven CRO providing full services in Biostatistics and Clinical Data Science

LET'S TALK ABOUT DATA

Unlocking the value of your real-world data

Our Mission
We are committed to provide Full Statistical Support to medical and clinical research at the core of each data exploration phase. We have a strong experience in Medical Affairs with Clinical studies , Registries, Post-Marketing and Real-World Data analyses. We collaborate with Biotechs, Pharmaceutical Companies, as well as Academic Institutes.
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Data Generation for Medical Affairs
Dive into your data and discover why your clinical product is unique!
We help you re-analyze your clinical databases, and develop observational and post-marketing studies to generate new insights about your drug on the market.
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Clinical Trial Data
Accelerate your IND application process with our Statistical Services. We help your research team to design your trial with an appropriate sample size, develop your Statistical Analysis Plan and deliver the Clinical Study Report on effective timelines.
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Our services & expertises

Biostatistics for
Clinical Trials

Phases I, II and IIIa/b, Study design, Sample size, Statistical Analysis Plans, Interim Analysis..

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Real World Evidence
studies

RWE/RWD generation, Late Phase study design, Observational studies, Claims Databases, Patient Registries...

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Medical Affairs
statistical support

Data-Generation for Data Mining, Post-hoc analyses, Scientific & Medical material generation..

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Clinical Data Management

CRF/eCRF design, Study databases build, CDISC standards, Edit checks, QC and validation...

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Statistical Programming

SAS 9.3/9.4, R, SDTM and ADaM standards, Mock tables, TFLs productions, QC ...

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Robust methodology

for successful research

The critical step in any research project is identifying the initial clinical question. Once the objectives are precisely defined, a robust statistical methodology as well as a specific selection criteria for the study population can be defined, guaranteeing optimal final results. Signfience provides services in :

  • Identification of primary, secondary and exploratory objectives
  • Designing of the statistical methodology for each study endpoint
  • Sample size and power calculations
  • Statistical testing and modeling (Logistic Regression, Cox models, Kaplan Meier curves, Propensity scores matching, etc.)
  • Statistical programming (SAS 9.3/9.4, R, Python)

Deciphering data

with Artificial Intelligence

The evolution of technology being utilized in the exploration of clinical data is accelerating. Novel methods of Machine and Deep Learning offer exciting new opportunities in data analyses and scientific discoveries. This scientific revolution created by Artificial Intelligence is part of the DNA of Signfience.

  • Re-analyses of structured and unstructured clinical data (RCT dabatases, registries, MRI imaging, Clinical reports) with Machine and Deep Learning models.
  • Supervised training of AI algorithms for the prediction of clinical events and diagnostics
  • Unsupervised patient data classifications (clustering) for the identification of specific patient profiles.
  • Deployment of machine learning algorithms (Random Forest, Gradient Boosting, Naive Bayes, etc.) and neural networks (RNN, CNN, etc.)

From raw data
to final report :

Accelerate your scientific workflow

The communication of study results to the scientific community and health authorities is a crucial step in the valorization of a research project.
Thanks to its team of experts in biometrics and programming, Signifience is committed to the production of precise and clear communication documents allowing information sharing and quality scientific publication:

  • Creation of Tables/Figures/Listing
  • Contribute to Clinical Study Report
  • Assistance in interpreting statistical study results
  • High quality statistical and graphical media for scientific publishing needs (manuscripts, abstracts, posters..)
  • Collaboration with scientific teams in order to design complementary analyses (subgroups analyses etc..)

Publications

External applicability of the Effect of ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS) trial: An analysis of patients with diabetes and coronary artery disease in the REduction of Atherothrombosis for Continued Health (REACH) registry
Jeremie Abtan , Deepak L Bhatt , Yedid Elbez , Gregory Ducrocq , Shinya Goto , Sidney C Smith Jr , E Magnus Ohman , Kim A Eagle , Kim Fox , Robert A Harrington , Lawrence A Leiter , Shamir Mehta , Tabassome Simon , Ivo Petrov , Peter R Sinnaeve , Prem Pais , Eli Lev , Héctor Bueno , Peter Wilson , Philippe Gabriel Steg ; REACH Registry Investigators
Internal journal of Cardiology
2023 Jan 1;370:51-57. doi: 10.1016/j.ijcard.2022.10.132. Epub 2022 Oct 19.
Clinical Significance of Culprit Vessel Occlusion in Patients With Non-ST-Elevation Myocardial Infarction Who Underwent Percutaneous Coronary Intervention
Batric Popovic , Gregory Ducrocq , Yedid Elbez , Christoph Bode , Shamir R Mehta, Charles V Pollack , Manel Sabate , Sunil V Rao , Alexander Parkhomenko, Laurent J Feldma , Neila Sayah , Marc S Sabatine, Philippe Gabriel Steg; TAO investigators
American Journal of Cardiology.
2023 Feb 1;188:95-101. doi: 10.1016/j.amjcard.2022.11.013. Epub 2022 Dec 6.
Alirocumab and Cardiovascular Outcomes in Patients with Previous Myocardial Infarction: Prespecified Sub-analysis from ODYSSEY OUTCOMES.
Chiang CE, Schwartz GG, Elbez Y, Szarek M, Bhatt DL, Bittner VA, Diaz R, Erglis A, Goodman SG, Hagström E, Jukema JW, Liberopoulos E, Loy M, Pordy R, White HD, Simon T, Steg PG
Canadian Journal of Cardiology
2022 May 26:S0828-282X(22)00337-3. doi: 10.1016/j.cjca.2022.05.021.
Identification of poor prognostic joint locations in an early rheumatoid arthritis cohort at risk of rapidly progressing disease: a post-hoc analysis of the Phase III AGREE study
Durez P, Westhovens R, Baeke F, Elbez Y, Robert S, Ahmad HA
BMC Rheumatology
2022 Apr 14;6(1):24. doi: 10.1186/s41927-022-00252-4
Prediction of flare following remission and treatment withdrawal in early rheumatoid arthritis: post hoc analysis of a phase IIIb trial with abatacept.
Ahmad HA, Baker JF, Conaghan PG, Emery P, Huizinga TWJ, Elbez Y, Banerjee S, Østergaard M
Arthritis Research & Therapy
2022 Feb 16;24(1):47. doi: 10.1186/s13075-022-02735-8.
Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial.
Thaçi D, Strober B, Gordon KB, Foley P, Gooderham M, Morita A, Papp KA, Puig L, Menter MA, Colombo MJ, Elbez Y, Kisa RM, Ye J, Napoli AA, Wei L, Banerjee S, Merola JF, Gottlieb AB.
Dermatology and Therapy
2022 Feb;12(2):495-510. doi: 10.1007/s13555-021-00649-y
Presence of anti-cyclic citrullinated peptide antibodies is associated with better treatment response to abatacept but not to TNF inhibitors in patients with rheumatoid arthritis: a meta-analysis.
Alemao E, Postema R, Elbez Y, Mamane C, Finckh A.
Clin Exp Rheumatol
2020 May-Jun;38(3):455-466. Epub 2019 Nov 16. PMID: 31770089
Generalizability of the REDUCE-IT Trial in Patients With Stable Coronary Artery Disease.
Picard F, Bhatt DL, Ducrocq G, Elbez Y, Ferrari R, Ford I, Tardif JC, Tendera M, Fox KM, Steg PG
J Am Coll Cardiol.
2019 Mar 26;73(11):1362-1364. doi: 10.1016/j.jacc.2019.01.016. Epub 2019 Feb 25. PMID: 30819552
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SIGNIFIENCE

PariSanté Campus

2 – 10 Rue d’Oradour-sur-Glane

75015 Paris

contact@signifience.com