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Plaque Psoriasis Case Study

Indero

Indero

Team of Experts

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Click here for a PDF version of this case study

Outcomes

Indero successfully managed this plaque psoriasis study and this resulted in:

Enrollment completion 5 months earlier than planned

 

Study Characteristics

  • Study Phase: II
  • Patient Population: Plaque Psoriasis
  • IP Route of Administration: Systemic
  • Total Enrollment: 224 patients, 59 sites (North America & Europe)​

 

Complex Study Procedures

  • TBNK / hsCRP: Non-frequent procedure necessitated collaboration with central lab to customize the kits and lab manual
  • Genetic testing
  • Novel take-home photography equipment

 

Study Challenges and Solutions

Challenges #1

IP Availability: Sponsor decided to initiate the study even if there was no sufficient IP available to cover all regions

Solutions

  • Indero adapted the country and site activation strategy accordingly
  • Activated less European sites than expected
  • Careful monitoring of the number of patients enrolled per site and regular communication with the sites

 

Challenge #2

IP Stability: IP stability data confirmed the drug’s expiry date could be extended, which required sites to relabel the IP up to 3 times, due to study duration

Solution

  • Indero shared specific relabeling procedures with sites and supported them during the process, ensuring impeccable documentation

 

Recruitment Curve

 

Strategies for Success

  1. Strong recruitment strategies were established due to expected recruitment challenges
  2. LTE and OLE parts were added to protocol
  3. Opened recruitment in Europe, in addition of North America

 

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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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