Clinical Development Consulting

Integrated Guidance to Help You Successfully Bring Your Product to Market

Clinical Development Consulting

Integrated Guidance to Help You Successfully Bring Your Product to Market

Our Expert Team Will Help You Create a Clinical Development Plan Fully in Line With Your Product While Ensuring Regulatory Compliance
  • Be ready for regulatory reviewer teams by gaining an integrated perspective.
  • Save clinical trial costs and time with the right combination of experts advising your team.
  • Prepare for your post-marketing strategy with access to a broad range of experts in Real-World Solutions, Market Access, and Transaction Advisory.

Our Team Reflects the Structure of an FDA, EMA,
or Notified Bodies Reviewer’s Team

Regulatory Strategy

Our Regulatory experts prepare you for interactions with regulators in the European Union and United States across all stages of drug or medical device/IVD development. We provide support on writing/drafting a regulatory strategy and gap analysis, review of clinical trial protocol for regulatory compliance, accelerated development programs such as the FDA’s Breakthrough Therapy Designation and Breakthrough Device Designation and EMA’s PRIME for priority medicines, company core data sheet, label design, investigational new drug application/clinical trial application, biologics license application/new drug application/marketing authorization application, and preparation for the regulatory submissions for FDA device clearance/European conformity CE marking. 

Medical Strategy

Our Medical Strategy team brings deep expertise to provide guidance every step of the way to ensure that your plan is ready for every contingency and opportunity. 

Biostatistics

Our Biostatistics team contributes unmatched statistical expertise to optimize sample sizes, time to decision, and/or de-risk studies using innovative trial designs, such as Adaptive and Bayesian. 

Clinical Operations

Our Clinical Operations team takes a cross-functional approach to meet global regulatory requirements and complex endpoints through traditional and innovative study designs. 

Patient Engagement

Our Patient Engagement team partners with patients along the product development cycle thanks to patient advisory boards, patient support groups, and patient mobilization programs for clinical trials. 

Why Choose Us to Support Your Clinical Development Plan?

Mock negotiations and payer consultations
 

Contact Us to Learn How We Can Help You Successfully Bring Your Product to Market

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