For us, one size never fits all in clinical trial development.

Our flexible approach makes our expertise available to clients of all sizes and at all stages of their drug development process – and our expanding global footprint means we can conduct trials in a growing list of countries.

We lead the industry in early phase and complex trial protocol design with the goal of obtaining the data needed to take forward to the next trial stage, and we are adaptive and agile in managing the challenges inherent in any clinical study.

Trial protocol design is critical to optimise success.

Integrated Product Development

 

Our Regulatory consulting team help expedite the drug development process. Our highly experienced team, including former regulators, provide expert advice on:

  • potential approval pathway(s), including expedited approval
  • review of precedents with similar products
  • proposed Regulatory agency interactions and support with Scientific Advice meetings, including storyboarding and preparation of the briefing documentation

Our Clinical Development Consultancy is a highly flexible service where we provide our clients with access to industry-leading expertise to support first time in human clinical development planning, from discovery through to the clinic. Our support can range from an interactive development workshop to providing flexible project leadership with access to specialists covering:

  • Regulatory Strategy
  • Translational Science
  • CMC
  • GLP/Tox
  • Medical Science
  • Data Science
  • Advanced Therapies

Our Team Advises On:

Study design concepts
Regulatory requirements
Patient inclusion and exclusion criteria
Study endpoints and biomarkers
Clinical & operational aspects of design
Discussions with key opinion leaders

Solutions as Individual as your Product

We offer experienced industry experts to support in a range of potential problem areas to address issues with your product before they arise, minimising delays and costly changes. Aptus' scientific origins means we understand the significance of getting new therapies to patients as quickly and efficiently as possible, safely.