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Hidradenitis Suppurativa (HS) Case Study

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Team of Experts

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Outcomes

Innovaderm successfully managed this HS study and this resulted in:

  • Enrollment completed 3 months ahead of schedule

Study Characteristics

  • Study Phase: II
  • Patient Population: Hidradenitis Suppurativa
  • IP Route of Administration: Systemic – Subcutaneous
  • Site distribution: 25 in North America and 16 in Europe

Study Challenges and Solutions

Challenge 1: Recruitment

Several screen failures (SF) due to late availability of lab results

Solutions

  • Pro-active monitoring of lab results regarding patients’ eligibility by project team
  • Flagged alerts to individual sites and follow-up with central lab on unexpected delays

Outcome

  • Screen failure rate reduced due to early identification of lab errors and lab patients’ tests adequately screened

Challenge 2: Shipments

Transportation fees (i.e., couriers) especially for lab samples from countries outside European Union

Solutions

  • Thorough assessment of cost drivers for shipment frequencies (sample stability and required turn-around time to obtain results)
  • Regrouping of shipments and modification to the lab panel to respect budgeted fees

Outcome

  • Significant reduction in shipping costs

Challenge 3: Academic sites

Delay in start-up activities due to large proportion of academic sites in the study

Solutions

  • Frequent, tailored 1:1 calls with PIs prior to study initiation
  • Site-centricity (i.e., involvement from onset of study)

Outcome

  • Early-stage discussions with PIs helped streamlined recruitment and start-up timelines

Key Success Factors & Strategies

  • Optimal site selection: experienced PIs in HS and experienced Innovaderm sites
  • Implemented broad reach digital ad campaigns / assisted sites with the development of recruitment material
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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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