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PRECLINICAL STUDIES

 

WHY 

  • To check and compare the in vivo performances of your prototypes
  • To demonstrate the general and local safety of your implantable device in accute phase and long-term period
  • To assess the efficacy of a new therapy relatively to gold-standard treatment

The justification of a preclinical investigation may be Regulatory Filing, Upstream Research or a need for Medical and Scientific Information.



WHAT 

  • In-vitro proliferation assays on drugs and biomaterials in animal and human cancer cell lines, fibroblasts, endothelial cells
  • Large in-vivo models of healthy tissues, vascular, inflammatory and cancer disease: healthy models of vascular embolization in sheep, swine and rabbits, subcutaneous implantation tests,  hypervascular VX2 tumors in rabbits
  • Molecular biology: ELISA and Western blot protein quantification in tissues samples, cDNA microarrays for gene expression in all animal species
  • Pathology: conventional staining (HES, Masson, orcein, Sirius red, Perls...), digitization of histology sections, image analysis and morphometric measurements, ground sectioning of hard samples, immunohistochemistry and in situ hybridization for microvascular density, cell proliferation, inflammatory cells
  • Access to Imaging Plateforms: 3D Angiography (see animation), MR Imaging of tumor in vivo / ex vivo (T1, T2, DWI, Gd enhanced…), Ultrasound follow-up of tumor volume
  • Physical and chemical testings: compression tests, granulometric analysis, catheter injectability, in vitro resorption, chemical imaging of devices and tissues (infrared, Raman and fluorescence microspectroscopies
  • Pharmacology: Plasma and tissue dosage of antineoplastic drug, PK analysis
  • Data analysis: parametric, non-parametric, multivariate statistical analysis


WHO


Procedures are performed by KOLs with long experience in preclinical models. Analyses are performed in collaborations with Academic and Private Labs under the supervision of the Management Team and of Institutional Experts.


HOW


Assignment for a single Service with delivery of raw data or for a complete Protocol from Study Design to Study Report and Scientific Communication  


The experimentation facility is certified EN ISO 9001 and EN ISO 13485 by G-Med.

Archimmed has experience in conducting GLP compliant Protocols.

All protocols are reviewed by the local Ethics Committee (COMETHEA) and get approval of the Ministère de l'Enseignement Supérieur et de la Recherche according to the European Directive 2010/63/EU and its transposition in French Law.

Archimmed has received accreditation for conducting R&D Projects eligible for Credit D'impot Recherche by the French Ministry of Education and Research.

TRAINING WORKSHOPS

TRAINING WORKSHOPS - PCRO

Archimmed organizes Training and Education Workshops for Health Care Practionners.

Workshops in the fields of Interventional Radiology, Gynecologic Surgery are currently held.




 Our mission :

  • define with you the objectives of the Workshop and the most suitable model for the procedure,
  • provide you with the services of a Specialist physician if required,
  • proceed with Ethical Committee submission and approval,
  • organize the Session with you, the Breeding and Experimentation facilities, accomodations...  
  • assist your staff on the day of the Session: veterinary monitoring, technical and scientific support, evaluation form and feedback from attendees.

CONSULTING SERVICES

CONSULTING SERVICES - PCRO

Not all our Sponsors wish to conduct a full preclinical study. Some manufacturers have their own experimental facilities but lack a specific know-how.

Archimmed asserts 10 years of Technical and Management Expertise in the field of Medical Devices for Interventional Radiology.



Our mission :

  • assist your team in the design, writing or critical review of your preclinical Study Protocol, in the choice of a CRO, in the preparation of Regulatory Filing and audits of Notified Bodies
  • technical consulting for in vitro / ex vivo / in vivo analysis,
  • take advantage of our network and get connected to Specialist you need,
  • on-site inspection of veterinary and analytical facilities.
PCRO