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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
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Jeff Smith, Chef de la direction d’Indero Recherches, apporte près de 30 ans d’expérience dans l’industrie pharmaceutique et CRO, s’étant distingué par son leadership exceptionnel, sa vision stratégique et son innovation. L’expertise de Jeff couvre des opérations mondiales, la gestion de la croissance, ainsi que la promotion d’une culture d’entreprise collaborative. Ses atouts en matière de création de valeur, de gestion des partenaires et d’opérations CRO ont toujours contribué au succès dans ses fonctions précédentes. Sous la direction de Jeff, Indero continue d’étendre ses capacités, faisant progresser les connaissances médicales et les nouvelles thérapies en dermatologie et en rhumatologie.

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