Expertise
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Custom-made solutions
Heva works with pharmaceutical and medical device manufacturers, biotech companies and academic sponsors on all types of projects, both pre- and post-approval, in France and abroad.
Heva provides its customers with a wide range of expertise and innovative capabilities, combining scientific and methodological skills with advanced data analysis techniques. Our experts are able to provide overall or partial management of your projects.
Scientific and Medical
Regulatory
Project management
Monitoring
Data Management
Biostatistics and Datascience
Digital and
applications
Acuitude Division: Agreements and compensation
Scientific and Medical
Our team is made up of pharmaco-epidemiologists, medical methodologists and medical writers with a solid scientific and methodological background, enabling us to propose innovative designs tailored to your study needs. Our expertise in methodology, data knowledge and medical writing (protocols, reports, scientific articles) guarantees the rigor, clarity and quality of your studies.
The Scientific Department works in collaboration with all Heva teams to ensure the scientific integrity of projects and the production of reliable, reproducible and usable results, both for publication and for medical and regulatory decision-making.
Scientific excellence
Advanced and innovative methodologies expertise
In-depth knowledge of health data
Expertise healthcare stakeholders needs
Regulatory
The team is involved right from the design phase, assisting with the drafting of essential documents (protocol, information leaflet, consent form, etc.).
The team prepares and monitors regulatory submissions to the relevant authorities (CPP, ANSM, CNIL, CNOM, etc.). The team ensures that the correct submission processes are followed, on the different platforms (CTIS, SI RIPH2G, IDAHE, EPS, Transparence Santé), depending on the type of study.
The team ensures strict compliance with regulatory requirements at every stage of the project.
Project management
Our team of project managers is supported by responsive assistants, fully dedicated to the success of your studies. They ensure that each project is managed smoothly and rigorously, from the analysis of your needs right through to delivery of the results, with constant attention to deadlines, budgets and quality.
In addition to operational management, each project manager mobilizes his or her specialized expertise - regulatory, clinical, medico-economic, organizational ...- to anticipate challenges, secure each stage of the project and provide you with tailor-made solutions. Our commitment: to provide you with reliable, personalized support that creates value.
Advice and expertise to choose the best study strategy
Project team management
Quality and deadlines commitment
Rigor and responsiveness
Monitoring
The team is made up of around ten clinical research associates. Their mission is to ensure that clinical trials run smoothly.
The team ensures that patients' rights are protected, the protocol, regulations and Good Clinical Practice (GCP) are respected at every stage of the study, so as to guarantee the quality of the data collected (reliability, completeness and traceability).
The team collaborates with sponsors and investigating centers (hospitals, clinics and doctors' practices).
The team works daily on different systems: CTMS (SimpleTrials, Veeva, ...), eCRF (Ennov Clinical®, EDC adapted to early access (CleanWeb® from Telemedicine ****Technologies), or on specific tools requested by our customers.
Data Management
The team is made up of data managers who organize the collection of medical data and ensure its quality,. They also transform complex data to enable and enhance the analysis.
the team conducts a collaborative work to ensure the development and maintenance of its tools (document framework, CDISC exports, Python packages and SAS macro).
Each study on primary and secondary data benefits from technical solutions adapted to international regulatory requirements.
The systems used are qualified and validated (Ennov Clinical®, CleanWeb®) and comply with current CNIL standards (Système fils SNDS).
Biostatistics and Data science
The team brings together biostatisticians and data scientists with complementary skills, specialized in healthcare data strategic analysis. With solid experiences in primary data analysis (clinical trials, observational studies) and secondary data analysis (SNDS, hospital databases, real-life data), we cover the entire healthcare data lifecycle.
The team masters a wide range of methods: survival analyses, causal models (propensity score, matching), process mining, advanced clustering (HCA, k-means, DBSCAN), PLS-DA, time series (ARIMA, LSTM), and machine learning algorithms. Each approach is chosen according to your objectives, with one constant requirement: to deliver innovative, interpretable results that comply with regulatory standards.
The biostatistics and data science team is committed to producing robust, documented and reproducible analyses, on time and to the highest scientific standards.
Proficiency in R, Python and SAS tools
Digital and applications
Heva digital team designs tools and medias dedicated to data analysis and visualization. The team brings together designers and developers who transform complex content into clear, interactive and engaging digital experiences.
Our applications meet a wide range of challenges: modeling, decision support, optimization of care pathways, territorial analysis, economic valuation... They provide intuitive, dynamic results, through interfaces designed for business use.
Heva digital team pay a particular attention to data visualization, wich is a key challenge with complex health data. We develop in-house tailor-made digital solutions to reduce this complexity.
In addition, the design team imagines and produces scientific and educational communication media: posters, videos, glossaries, booklets... designed to combine rigor, readability and visual impact.
Acuitude Division: Agreements and compensation
The Acuitude center of expertise handles all administrative and financial aspects of compensation for healthcare professionals, institutions and associations.
Our teams, both expert and flexible, can adapt to your needs, handling all or part of the process: declaration to professional bodies, contractualization, payment and transparency obligations.
Acuitude covers a wide range of activities, from clinical research to derogatory access, as well as the organization of healthcare events (congresses, training courses, webinars, etc.).
Strategic advice and support
Contractualization and payment of healthcare professionals
Compliance with legal and regulatory requirements