Supporting Documentation Development

PharmaLex has a deep understanding of the detailed format and content for supporting documentation required by the regulatory authorities. We can provide specific or turnkey services in their preparation.
     Investigators’ Brochure (IB)

  • Module 1 IND/CTD(Section 1.14.4.1)
  • Summaries of nonclinical pharmacology/toxicology, CMC, clinical trial results (as they become available), and risk-benefit analysis of the drug
     

     IRB Documentation

  • Documented in accordance with applicable regulatory guidelines
  • Prepared in conjunction with FDA Form 1572
  • Designed to work with Central, Local, and University IRB Submissions
  • Tailored to meet the needs of the chosen IRB

   

     Informed Consent

  • Developed to meet the required elements of Informed Consent and Subject Safety
  • Written in non-technical language for ease of understanding
  • Created to meet ICF translation requirements into other languages