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Our capabilities | R&D | Grünenthal Pharma Ltd. Ireland

From drug discovery to

Strategic translational science –
building the bridge to humans

We create excellent solutions to translate pre-clinical trial results into successful early human clinical trials.

Our expertise includes:

  • innovative models and biomarkers translatable from in-vitro studies to rodent animal models to man.
  • novel biomarkers and pharmacodynamic models in healthy volunteers
  • innovative pharmacology and proof of concept clinical trial design, including outcome measures

Solutions-focused clinical development

We design clinical programs to address patients’, KOLs’, regulators’ and payors’ demands from early on – irrespective of indication, patient population or therapeutic approach.

Solutions focus:
In brief

  1. We are developing new Patient-Reported Outcome (PRO) measures for specific diseases to meet the needs of payors. We are the only company bringing PRO measures to early development in pain.
  2. Through our tapentadol paediatric program, we are conducting pioneering research and designing special protocols to drive solutions for babies, children and adolescents. We are strongly committed to the unique needs of children and their parents.
  3. In Latin America, we focus on projects to meet the specific needs in that region (pain, women’s health and CNS).

Our expertise includes:

  • holistic clinical trial strategy and planning
  • full clinical trial operations
  • experienced CRO management
  • best-in-class data management, data analysis and modelling, and simulation

Clinical Operations (CO) –
delivering high quality clinical trials

We collaborate with internal and external commercial partners to ensure the delivery of clinical trials in line with timelines, budget, and adherence to the highest quality and ethical standards.

Our Clinical Operations model

We follow a lean model to provide the right level of oversight to studies and programmes in our pipeline, but always strive for maximum efficiency. This allows us to increase speed to market, yet observe the highest quality standards and bring new medicines faster to our patients.
... pipeline

Our expertise includes:

  • clinical trial management
  • clinical trial oversight
  • clinical trial supply
  • data and documents operations
  • quality management services and compliance
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