SCOPE

CoLAB TRIALS activities are specifically
focused on:

Transform Real World clinical data aligned with FAIR (Findable, Accessible, Interoperable and Reusable) principles in Real Time.

Pre-clinical and clinical study design and planning for early clinical evaluation of new health technology products: Medical Devices, in-vitro diagnostic devices, biomarkers, biologics (including ATMP).

Capacitation of clinical teams in clinical trial project management (Tools and Internal Circuits).

Community Literacy in Clinical Trials (Tailored training to professional orders and municipalities).

New tools for
clinical trials
Increase TRL of
health products
Design innovative
studies
EXPLOIT CLINICAL
BIOMEDICAL DATA
International
Funding

PROJECTS

CoLAB TRIALS brings together Healthcare Units, Patient and Pharma/Biotech Industry associations, and Universities.

Our ecosystem makes us as a critical partner in projects aiming at:

  • The clinical evaluation of health technology products (medical/ in vitro diagnostic devices, chemicals and biologicals) and/or;
  • The community literacy in clinical trials and/or;
  • The capacitation of clinical teams in trials’ project management and/or;
  • The access to real time and real-world clinical data for sharing and reuse according to FAIR principles and the GDPR.

 

Working with our associates:

Participation in Worldwide collaborative consortia as partners with over 220 organizations from 32 different countries

Implementation of workshops for empowering health professional on EU funded project planning and  management

Development of IT solutions to i) manage and facilitate clinical trials  ii) support on regulatory roadmap for medical devices development

Support to associates and SMEs

  • Support pre-clinical study design (new drug, TRL 4)
  • Plan the regulatory roadmap for technical validation and clinical evaluation (combined ATMP product, TRL 4)
  • Plan the regulatory roadmap for technical validation and clinical evaluation (medical device, TRL 5)
TOOLS
This tool has been designed to assist you in determining the risk classification of your medical device in accordance with the EU regulation 2017/745 on medical devices (EU MDR) and its guidance document regarding classification. At the end of the questionnaire (5-10 min) you will get the risk classification of your device, as well as a brochure summarizing what you need to know in order to bring your idea to the market.

Click here to access the questionnaire
1
Answer a few questions (~3 min)
2
Determine the risk class of your device
3
Get the certification roadmap for your product!