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Expertise

Accompanying you is our priority

We are able to support you in your studies regardless of the therapeutic area or type of health product.

We have extensive experience in clinical or epidemiological studies, on drugs or medical devices.

  • Clinical studies : Assist partially or totally in all phases of design and implementation of your interventional study projects,
  • Early and Compassionate Access (for drugs) : Help holders of innovative molecules in writing the protocol of the early or compassionate access program, implement all the logistics necessary for the management of data collection, write the periodic reports for HAS or ANSM,
  • Non-interventional studies : Whether determining the prevalence/incidence of diseases, the characteristics of patients and/or prescribers, estimating efficacy/safety in real life, we are specialists in this type of study, accustomed to meeting the needs of customers and the requirements of health authorities.
  • Qualitative studies*: Qualitative methods focus on how individuals relate and understand what they are experiencing: their internal experiences, their actions, and what surrounds them. In health research, these approaches, focused on the “patient experience”, make it possible, for example, to determine relevant judgment criteria, to evaluate the experience of the disease and/or care from the patient’s point of view.

* AXONAL-BIOSTATEM has signed a partnership with IPSEA to managed its studies.

01

Drugs

02

Medical devices

03

Other health products

04

Other expertise

01

Drugs

  • We design and implement all types of drug studies
  • Clinical studies from phase I to phase IV
  • Non-interventional studies in the form of a register, observatory, cohort study
  • Early and Compassionate Access: Help holders of innovative molecules in the drafting of the protocol for early or compassionate programs, implement all the logistics necessary for the management of data collection, write periodic reports for HAS or the ANSM
  • Epidemiological, pharmaco-epidemiological, medico-economic studies
  • Studies linked with SNDS data
  • We have all the expertise and trades in-house
  • We are qualified by many large international groups
  • We carry out studies with academic sponsors, funded or not by industry
  • We design synopsis, protocols and CRFs in collaboration with scientific committees and sponsors
  • We prepare and manage regulatory submission files in all countries
  • We offer high-performance technical solutions for data collection (eCRF, ePRO applications, specific scoring, educational tools, applications on mobile devices)
  • We offer centralized or/and on-site monitoring depending on the studies
  • We can help the investigating sites by delegating Clinical Research Technicians on site
  • Our Biometry Department is made up of several Data Managers, Statisticians, Methodologists and Data Entry Operators
02

Medical devices

  • We design and implement studies or data collection

  • We carry out studies to obtain CE marking, post-marking studies to request reimbursement in France, SCACs to respond to HAS post-registration requests

  • We have all the expertise and jobs in-house to carry out a full study

  • Our internal and external consultants can draft marking and reimbursement files in France

03

Other health products

We also have the competence to design the methodology and carry out any type of study in health fields such as non-drug interventions, cosmetology, nutrition, homeopathy, veterinary medicine.

04

Other expertises

  • Design and organization of seminars and training on topics related to our expertise and the analysis of health data
  • Provision of technical solutions (eCRF, ePRO, IWRS randomization, apps on smartphones and tablets, development of specific applications)
  • Advice and assistance in responding to study requests from the authorities
  • Methodological advice in the development of protocols
  • Medical writing: protocol, newsletter, study reports, abstract, poster, scientific article
  • Assistance in finding research funding

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