Biomarkers and assays development CRO services

ImmuneHealth has developed CRO service activities for Sponsor companies. In this context, we implement clinical studies enabling the development of biomarkers and laboratory assays.

Through its team of experienced investigators, study nurses, and laboratory staff, ImmuneHealth can recruit study patients, perform study procedures, and on-site sample handling and process. ImmuneHealth team can also support clinical sites with the conduct of the study in a multicenter approach.

With our experienced CPM, CRA we offer a full range of CRO service activities including:

• Feasibility assessment
• Development of study protocol and ICF, as well as other study documents (study procedures, laboratory manuals, CRF,…)
• Intellectual input and advice on your project design
• Sites selection
• Ethics Committee submission
• Study operational set up and study coordination (including tracking of biological samples)
• Recruitment
• On-site sampling, processing and storage
• Clinical data collection
• Clinical study administration
• Logistical support
• Regulatory support
• Study monitoring and reporting activities
• Data management and biostatistical analysis (including predictive modelling) through its collaboration with DNALytics.

All activities and studies are designed and implemented in compliance with the highest ethical and regulatory standards, including ICH-GCPs, requirments of the Belgian Law on Human experiments and Biobanking for research applications.

 


 

  1. Loi du 7 mai 2004 relative aux expérimentations sur la personne humaine,
  2. Loi du 8 décembre 1992 relative à la protection de la vie privée (modifiée par la loi du 11 décembre 1998 transposant la directive européenne 95/46/CE du 24 octobre 1995),
  3. Loi du 22 août 2002 relative à la protection des droits des patients,
  4. Loi du 19 décembre 2008 relative à l’obtention et à l’utilisation de matériel corporel humain destiné à des applications médicales humaines ou à des fins de recherche scientifique.

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