CAPABILITIES

From proof-of-concept to market, Iasis Partners provides customized services for product development based upon each client’s individual needs and objectives. We support all stages of product development across all major product classes and therapeutic areas.  Members of Iasis Partners’ team work as integral members of the client’s development team to assist in the creation and implementation of a sound development program. We understand the nature of commercial product development in an environment of regulatory requirements and constraints, and strive to maximize success and minimize risk.  

In addition to our main focus on strategic planning and clinical and regulatory support, Iasis Partners provides guidance and support in preclinical safety and toxicology, pharmacokinetics, and statistics, and through our affiliates, support for clinical operations and data management.  We conduct due diligence in anticipation of product/company acquisition or as part of internal quality assurance processes.   We also provide scientific and medical advice for pre- and post-approval support, litigation support, and expert witness services for law firms in civil and criminal cases, including patent and regulatory matters.

Strategic Planning

  • Assist in creating comprehensive, customized product development plans to be consistent with corporate objectives and regulatory requirements
  • Review and advise on proposed project pathways and critical documents, particularly at key milestones in drug development programs such as Pre-IND, End-of-Phase 2, and Pre-NDA/BLA
  • Conduct thorough due diligence reviews of candidate products, examine preclinical and clinical dossiers, conduct gap analyses of key areas, and assess potential for success based on medical need, competing products, and defined regulatory and clinical pathways

Clinical Affairs

  • Provide ongoing clinical strategy and guidance for clinical development plans
  • Assist in design of clinical programs, protocols and study related documents
  • Provide medical monitoring services
  • Advise on design and implementation of comprehensive risk management systems, and good human research and pharmacovigilance practices
  • Create, interact with, and potentially lead client Safety Management Committees internally chartered to proactively anticipate, identify, and manage emerging safety signals throughout the product lifecycle
  • Participate in Data Monitoring Committees (DMCs, DSMBs, DSMCs) to ensure the safety of human subjects and trial data and integrity, and make recommendations concerning the continuation, modification, and termination of trials as they are being conducted
  • Advise on interpretation of study results and assist in preparation of clinical study reports

Regulatory Affairs

  • Provide ongoing regulatory strategy and guidance for product development plans
  • Conduct thorough reviews of INDs, identify existing regulatory compliance issues and deficiencies, and advise on corrective actions
  • Prepare and manage initial and ongoing IND activities in compliance with applicable U.S. federal regulations, ICH guidelines, and Good Clinical Practices, including clinical, pharmacology, toxicology, and chemistry amendments, IND safety reports, and annual reports
  • Prepare and review critical documents intended for regulatory submission, including clinical protocols, clinical study reports, human experience section of INDs and Investigator Brochure, integrated efficacy and safety summaries and related sections of INDs and NDAs/BLAs, background packages for regulatory agency briefings and advisory committees, and draft labels
  • Assist clients in preparing for and participating in meetings with the U.S. Food and Drug Administration (FDA), and in defending client submissions to FDA reviewers

Preclinical

  • Advise on design of preclinical programs in safety and toxicology, and pharmacokinetics, considering regulatory requirements and need for accelerated development
  • Review and advise on protocol development and assist in study implementation
  • Advise on analysis and interpretation of study results and assist in preparation of preclinical study reports
  • Assist in preparation of relevant sections of INDs and NDAs/BLAs

Statistics

  • Provide statistical expertise in clinical study design and implementation, endpoint selection, data collection and analysis, and interpretation of study results
  • Provide statistical programming services
  • Advise on clinical trial data management systems
  • Assist in preparation of statistical reports and regulatory submissions
  • Assist in preparation for meetings with FDA, and in defending submissions to FDA reviewers

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