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Alopecia Areata (AA) Case Study

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Team of Experts

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Outcomes

  • Innovaderm’s outstanding support on this alopecia areata study resulted in a rapid increase in enrollment rates and the successful management of this trial

Study Characteristics

  • Study Phase: II
  • Patient Population: Alopecia Areata
  • IP Route of Administration: Systemic
  • Sites distribution: 12 sites (CAD-USA)
  • Complex study procedures: Ophthalmology and Pulmonary function tests

Study Challenges and Solutions

Challenge 1: Site Engagement

Withdrawal of sites prior to / during SIV due to the complexity of the study

Solutions

  • More robust FQ and discussions during SQV ensured PI/sites had a clear understanding of the logistical needs to implement the study, as well as required resources

Outcome

  • Decrease in withdrawal of sites

Challenge 2: Recruitment

  • Recruitment rates are below expectations. Sites in need of better support

Solutions

  • Conducted frequent 1:1 calls and follow-ups with sites to review recruitment plans
  • Assisted with extensive tracking of referrals,  follow through and outcomes
  • Shared other sites’ practices on effective local recruitment initiatives

Outcome

  • Renewed efforts in recruiting led to screening activity increased within 2 weeks of the 1:1 site calls

Challenge 3: Central Laboratory

  • Over the holiday period, significant issues with samples were observed incl. shipping problems experienced by the Central Lab’s vendor

Solutions

  • Re-trained sites on best practices for processing samples
  • Increased sample stability
  • PM engaged in frequent communications with lab to proactively discuss possible delays in shipping

Outcome

  • >50% reduction in related issues regarding samples exceeding stability or being inadequate for processing

Key Success Factors & Strategies

  • Bi-weekly calls between CRAs & sites to focus on recruitment
  • Implemented 1:1 site booster calls to discuss specific challenges
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Jeff Smith

Chef de la direction

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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