Clinical

Atheln’s clinical experts can support companies through all stages of development

Atheln collaborates with a cadre of highly specialized physicians covering a broad spectrum of therapeutic areas. With substantial industry experience, our team comprehensively understands the intricacies of clinical trial strategy and design essential for the successful development of therapeutic products

The clinical experts have extensive experience in the regulated markets and support clients through all stages of development always in close collaboration with the CMC, nonclinical and regulatory teams.

Atheln’s Clinical services include:

  • Designing Clinical Programs for PIND and Scientific Advice meetings
  • Conducting clinical study protocol design from FIH to pivotal studies
  • Advising on CRO selection and managing CRO relationship
  • Communicating with KOLs
  • Evaluating and interpreting clinical study results
  • Writing regulatory filings and supporting meetings with regulators

Additional ancillary Clinical services include:

  • Statistical design and evaluations
  • Medical writing