Successfully Supporting Clinical Research Trials
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Endocrine/Metabolic

atnahs pharmaceuticals > Endocrine/Metabolic

Endocrine and Metabolic Disease Clinical Development Expertise

Overcoming complexities to bring more metabolic disease treatments to market successfully

Metabolic diseases are a rising therapy area focus for clinical research due to high demand for novel therapies that are challenged with proving safety and efficacy. The development process is complicated and full of unknowns, and even the best metabolic therapeutic might not make it to the patients that need it, not because it does not work but because the design, data collection, and analysis were not done right.

At Atnahs Pharmaceuticals, we have assembled an extraordinary team of scientific-minded experts who have mastered the complexities of running metabolic disease trials.   Our team has supported >180 projects for endocrine/metabolic disorder treatments and the preparation of 15 marketing applications – 13 of which have been approved so far!

 

Success with Lifestyle, Genetic, and Rare Metabolic Therapies

 

We strive to advance your novel metabolic therapies from Phase I-III clinical development to market with confidence.

Our experienced teams are poised to plan and implement these efforts quickly, providing:

  • Development of regulatory strategy, expedited pathways, and regulatory agency interactions
  • Clinical program planning, inclusive of statistical planning and analysis
  • Agile patient recruitment strategies to support virtual trial and hybrid approaches
  • Rapid deployment of clinical trial databases and data analysis and migration into CDISC formats
  • Virtual and remote clinical and medical site monitoring
  • Writing of clinical trial, safety, and regulatory documents
  • Preparation and defense of Marketing Applications – NDAs, BLAs, NDSs, MAAs, jNDAs, etc.
  • Post-Marketing Pharmacovigilance and Safety Monitoring to ensure patient safety beyond regulatory approval

Looking for a quality and affordable constructor for your next project?