LRA

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L I N E B E R R Y R E S E A R C H A S S O C I A T E S

Lineberry Research Associates offers clients a full range of services including consulting for all aspects of drug development, a complete scope of clinical research services and a variety of scientific writing and communications capabilities.

LRA services include:

S T R A T E G I C   C O N S U L T I N G

  • Pharmaceutical Chemistry and Formulation Development
  • Preclinical Toxicology, Pharmacology, Metabolism, and Pharmacokinetics
  • Strategic Planning for IND Submissions
  • NDA Clinical Development Programs
  • Marketing Considerations for Drug Development Strategies



C L I N I C A L   R E S E A R C H   A N D  
R E G U L A T O R Y   A F F A I R S

  • Clinical Protocol Development for Phases I-IV
  • Case Report Form Design and Preparation
  • Investigator Recruitment and Meetings
  • Management and Monitoring of Clinical Studies
  • Database Management and Statistical Analyses
  • IND/NDA Preparation and Submission
  • Strategic Planning and Client Representation for Regulatory Meetings (pre-IND, End-of-Phase II, Advisory Committees, NDA approval and product labeling)



S C I E N T I F I C   W R I T I N G   A N D  
C O M M U N I C A T I O N S

  • Final Study Reports
  • Integrated Summaries of Efficacy and Safety
  • Investigator Brochures
  • Product Labeling
  • Journal Articles
  • Monographs