Protocol Design

We help you design your clinical trial by:

  • Formulating a valid clinical trial hypothesis and specifying relevant clinical trial objectives.
  • Suggesting the exact clinical trial design methodology required for achieving all clinical trial objectives.
  • Precisely defining eligibility, inclusion, exclusion and discontinuation criteria of the study subjects.
  • Choosing appropriate psychometric, general health and Quality of Life instruments necessary for accurate and reliable clinical trial data collection and interpretation.
  • Timely clarifying all necessary ethical considerations including supporting your team in discussing and answering all questions and issues raised by Regulatory Authorities and Ethic Committees.
  • Accurately assessing clinical trial risk/benefit ratio.
  • Understanding current national standards of care.
  • Identifying KOLs acting as Members of DSMBs.
  • Identifying strengths and limitations of the study, i.e., what study can or cannot achieve, thus preventing wasteful allocation of resources.
  • Creating Informed Consent Forms and addressing physical, social and psychological implications of the study towards clinical trial participants.
  • Assessing all relevant preclinical and clinical data to be included in the Background section of the protocol.
  • FDA, EMEA and local regulatory requirements are all considered when preparing the protocol.