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Clinical Development

The clinical development experts at 2 Bridge bring ample experience in managing regional as well as global trials across all clinical phases (Phase I through IV) of the development trajectory. Besides the classic study, they can also provide sponsor representation in overlooking pediatric and observational trials, covering a broad coverage of therapeutic areas and treatment modalities.

Clinical Operations Capabilities

Clinical trial oversight

Trial preparation and management from initial design to close-out

Trial design and set-up

  • Design clinical trial protocols
  • Clinical study plans
  • Creation of study documents  – Clinical study protocol/ Patient documentation (ICFs, brochures, etc.)
  • EU CTR advice
  • Access to various experts: KoLs, Trial Physicians/Medical Monitors, PK experts, Biostatisticians, etc.

Trial Management

  • Sponsor representation
  • Medical oversight / trial physician
  • Clinical project & budget / time mgmt.
  • Vendor selection (CROs, data management, pharmacovigilance,..)
  • Vendor management
  • Training of CROs and sites
  • Clinical trial supply plans
  • Sample management and biobanking
  • Audit preparation
  • DSMB set-up, coordination

Trial close-out + documentation

  • Sponsor representation
  • Vendor close-out
  • Clinical study reports
  • Generation of external communication

Broad coverage across therapeutic areas and different therapeutic modalities

Phase 1 – 4, pediatric, observational trials
Therapeutic areas, including but not limited to cardiovascular, dermatology, gastro-intestinal, infectious diseases, immunology, oncology
Therapeutic modalities:
Small and Large molecules, Vacccines, Oligonucleotides, GMO, Microbiome, Medical devices
Global trial experience

Jannie Ausma

R&D Director, Clinical Development

Clinical research professional with a Ph.D. in Medical Sciences and over 20 years of experience in clinical development. Experience in all stages of clinical development (phases I, II, and III) and a mean track record in pediatric development, following an academic career of 10 years in cardiovascular research.

My work at 2 Bridge, as a clinical development expert in cross-functional development teams, giving strategic advice leading to overall development plans, results in enthusiasm to move the development of drugs forward to the next phase of clinical development.  Involvement in Scientific Advice with Competent Authorities (EMA, FDA or local authorities) is of added value for the client for the verification of the right development strategy, which excites me. The motivation of cross-functional project teams, with a strong hands-on mentality and always keeping a focus on timelines is my second nature.

Defining the right clinical development strategy during early development, from a cross-functional perspective by the 2 Bridge team, ensures successful drug development.