Types d’études

Types of studies

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Advising and supporting you at every step of your project

Heva supports professionals in the pharmaceutical and medical device industries, biotech companies and academic sponsors in all types of studies (clinical trials/clinical investigations, derogatory access, observational studies) and in all therapeutic areas.

Decentralized studies

Thanks to our recognized expertise in project management, we offer decentralized monitoring methods using digital tools such as ePRO for patient data collection, eCRF for secure investigator data collection, remote monitoring devices, or with dedicated staff in contact with the patient.

These solutions bring the study closer to the patient, reduce logistical constraints and optimize commitment, while maintaining the scientific, regulatory and ethical standards essential to the quality of clinical research.

Our expertise extends internationally, thanks to solid partnerships with trusted local players.

Clinical trials / clinical investigations

These studies enable sponsors to assess the efficacy and safety of a new drug or medical device. They are essential and necessary before a new treatment can be marketed. These trials are subject to a rigorous regulatory framework (ANSM, CPP, consent, insurance) to guarantee patient protection and reliable results.

Heva carries out this type of study in compliance with regulatory and ethical requirements.

	These studies meet different objectives: efficacy and safety. Find out more
	We implement all the logistics required to manage your project (scientific and medical, regulatory, project management, monitoring, data management, biostatistics...). Find out more
	The data used are primary data, collected on an ad hoc basis for the clinical trial. Find out more

Our strengths

Mastery of the regulatory and methodological framework

Compliance with GCP (Good Clinical Practices)

Patient safety and reliability of collected data

Data processing and analysis according to CDISC standards

Derogatory access: Early Access Authorization (EAA), Compassionate Access Authorization (CAA) and Compassionate Prescribing Frameworks (CPF)

These devices give patients suffering from serious, rare or incapacitating diseases, with no therapeutic alternative and requiring immediate treatment, access to innovative treatments that have not yet been granted with Marketing Authorization (MA).

Heva's long-standing position in ATU and RTU means that the company is one of the experts in the derogatory access system set up by the ANSM and HAS.

	We implement all the logistics required to manage your project (scientific and medical, regulatory, project management, monitoring, data management, biostatistics). Find out more
	The data used are primary, collected data. Find out more

Our strengths

CleanWeb facilitates data collection and management

Drafting of the PUT-RD or PUT-SP of the AP or AAC or CPC application file

Drafting of periodic reports

Central player: Consolidation of administrative management

Observational studies

This type of study consists in analyzing data from everyday practice (real life), without any direct intervention in treatment or patient care. It is used to determine the prevalence or incidence of diseases, the characteristics of patients and/or prescribers, and to evaluate the use, efficacy or tolerance of a health product in everyday conditions.

Heva is a recognized specialist in this field, meeting the needs of our customers and the requirements of health authorities.

	These studies meet a variety of objectives: epidemiology, efficacy, safety, care pathways, proper use, adherence to recommendations, medico-economics, healthcare supply. Find out more
	We implement all the logistics required to manage your project (scientific and medical, regulatory, project management, monitoring, data management, biostatistics...). Find out more
	Depending on the needs of the study, several types of data may be used (ad hoc data collection, PRO, SNDS, FREiA, medical records, registers / cohorts, health data warehouses, etc.). Find out more