Clinical Development Consulting
Are you looking to bring your product to the market?
Our expert team will help you to create a clinical development plan fully in line with your product, while ensuring regulatory compliance.
Benefit from our proven Regulatory, Clinical, Biometrics, Medical Strategy, and Patient Engagement expertise to achieve your goals. Our experts will guide and support you at every step of the clinical development plan.
Why Alira Health for your clinical development plan?
- Right combination of expertise and experience
- Team that reflects the structure of an FDA, EMA, or Notified Bodies reviewer’s team
- Fully customized and agile approach to your product
- Full suite of services for your post-marketing strategy, including Patient Engagement, Real World Solutions, Market Access, and Transaction Advisory.
Our senior experts will support your successful market entry:
- Regulatory: identify the best regulatory pathways in multiple therapeutic areas, such as orthopedics, orphan drug and/or pediatric programs
- Biostatistics: optimize sample sizes, time to decision and/or de-risk studies using innovative trial designs, such as Adaptive and Bayesian
- Medical Strategy: ensure the clinical relevance of the envisaged population, endpoints, and comparators
- Clinical Operations: improve operational feasibility of protocols, such as realistic enrollment, geographies and more
- Patient Engagement: capture the input of patients on endpoints and practicality of the protocols through consulting patient associations and more