Clinical Solutions

Looking to bring your newly developed medical device or new therapy – ATMP or otherwise – to the market? Then you have an extensive product life cycle process ahead of you, including clinical testing and validation. As part of our end-to-end offering throughout the entire ‘from idea to patient’ life cycle, QbD is there to guide you through those crucial clinical steps as well.

In order to advise and support you in the best possible way, tailored to your specific needs, we offer a unique combination of global CRO services, consultancy and quality & compliance services. And by we, we mean the entire team at QbD and TRIUM CLINICAL CONSULTING, who recently joined the QbD Group.

CRO Services

Looking for an expert CRO with a focus on medical devices and biotech? Then we’re your dedicated partner! Quality-driven and highly flexible, we manage your projects from A to Z, both on a strategic and/or operational level from pre- to post-market.

Our strategic solutions include regulatory (CTR, MDR, IVDR, competent authorities, …) and clinical strategies as well as medical writing (literature reviews, clinical evaluation reports, protocols, study reports, …).

We also offer the full range of clinical operation services including data management, biostatistics, EDC and IXRS, project and site management, competent authority and ethics committee submissions, safety, medical monitoring, CECs and DSMBs.

Consultancy

Looking for experienced clinical research consultancy or a consultant? Then you’ve come to the right place. You can either entrust our consultants with your projects or benefit from their skills on a more ad hoc basis.
One of our biggest strengths? Our flexibility.
We provide support on a global level, for short or long term assignments, in any clinical role, covered by a single consultant or an entire team.

Quality & compliance

With more than 250 quality experts, the QbD group is your partner for advice and support when controlling quality risks throughout your product’s life cycle.

In the clinical research field we consult and support you in:

  • Audit services (sites, sponsors, systems and technology)
  • Inspection preparation
  • General Data Protection Regulation (GDPR)
  • Risk-based approaches
  • Clinical QMS implementation and maintenance
  • Strategic quality consultancy
  • Root Cause Analysis & CAPA
  • ICH-GCP, ISO and Good Documentation Practices
  • SOP writing

Contact

Talk to a clinical expert

Don’t hesitate to contact us if you have a clinical program or project coming up. We will provide you with more information on our operations model and provide you with a custom-made and budget-effective solution.