Module 14 2022

21/03/2022

Metronomia - at a Glance

Our company name Metronomia is Greek for “managing the measurable”

Founded

1990

Privately owned CRO



Location

Munich

Regional coverage

Global

Core business = Data Science  Statistical services & consulting  Statistical programming  Clinical data management  Medical writing

Other services: 

Data Warehousing

PK Services

  

Safety Management Partnered Full-Service

The Organisation for Professionals in Regulatory Affairs

Statistical Considerations in Medical Device Clinical Investigations

3

Experience – 600+ clinical projects

Non- commercial Sponsors

Biotech

Pharma

CROs

Medical Device

Type

Number

Examples

Medical Device

60+

Clinical Investigations, PMCF studies, Registries, Surveys, IITs

Phase I

110+

HV or patient studies, BE/BA, PK-studies, Bayesian

Phase II

150+

PoC, dose-finding, pivotal IIb-studies

Phase III

85+

Seamless Phase II/III designs, adaptive designs

Phase IV

80+

Various indications

Other

95+

Non-clinical, NIS including registries, IITs

eCRF

70+

CLINCASE, RAVE



ePRO

12

Various devices and systems/vendors



The Organisation for Professionals in Regulatory Affairs

Statistical Considerations in Medical Device Clinical Investigations

4

2