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Acne Case Study

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Team of Experts

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Outcomes

  • Innovaderm successfully managed this acne study and this resulted in enrollment completed 1 month earlier than planned

Study Characteristics

  • Study Phase: II
  • Patient Population: Acne vulgaris (enrolling pediatrics & adults)
  • IP Route of Administration: Systemic
  • Sites distribution: 15 sites (USA)

Study Challenges and Solutions

Challenge 1: Administration Mode

Use of a novel route of administration for a population accustomed to topical and oral treatments

Solutions

  • Promoting the new treatment and clarity of messaging with the sites
  • Careful selection of sites

Outcome

  • Enrollment completed one month ahead of schedule

Challenge 2: Recruitment – Apprehension

  • Enrollment of pediatric population while managing patients’ and their parents’ fears regarding the route of administration

Solutions

  • Experience with pediatric enrollment was mandatory for sites
  • As minors tend to have compliance issues, the administration of a drug once every two weeks was a key advantage

Outcome

  • Recruited much more pediatrics than expected (+40%)

Challenge 3: Pandemic

  • Enrolling during the first waves of COVID-19 could have impacted recruitment & operations (site staffing, monitoring visits, etc.)

Solutions

  • Sites were prepared to operate and follow new safety guidelines regarding COVID-19

Outcome

  • The study proceeded as scheduled

Key Success Factors & Strategies

  • Local advertisement campaigns to increase engagement
  • Implemented remote monitoring during COVID-19 to maintain workflow efficiency
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Jeff Smith

Chef de la direction
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Jeff Smith, Chef de la direction d’Indero Recherches, apporte prĂšs de 30 ans d’expĂ©rience dans l’industrie pharmaceutique et CRO, s’Ă©tant distinguĂ© par son leadership exceptionnel, sa vision stratĂ©gique et son innovation. L’expertise de Jeff couvre des opĂ©rations mondiales, la gestion de la croissance, ainsi que la promotion d’une culture d’entreprise collaborative. Ses atouts en matiĂšre de crĂ©ation de valeur, de gestion des partenaires et d’opĂ©rations CRO ont toujours contribuĂ© au succĂšs dans ses fonctions prĂ©cĂ©dentes. Sous la direction de Jeff, Indero continue d’étendre ses capacitĂ©s, faisant progresser les connaissances mĂ©dicales et les nouvelles thĂ©rapies en dermatologie et en rhumatologie.

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