INNOVADERM CRO IS NOW INDERO.
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Generalized Pustular Psoriasis (GPP) Rescue Case Study

Indero

Indero

Team of Experts

Outcomes

Innovaderm successfully transitioned this rescue study from another CRO and this resulted in:

  • More than doubled patient enrollment in 1 month
  • Started enrollment 1 month faster than initial projection
  • All 5 newly added sites were actively recruiting

Study Characteristics

  • Study Phase: IIa
  • Study Type: Rescue study
  • Patient Population: Generalized Pustular Psoriasis (GPP)
  • IP Route of Administration: Systemic
  • Original Sites at Rescue: 7 in 2 continents (4 North America, 3 Europe)
  • Post Rescue Final Sites Distribution: 10 in 3 continents (7 Europe, 2 North America, 1 Asia)

Study Challenges

  • GPP is the rarest form of psoriasis – Global prevalence of 1-9/1,000,000
  • Patients had to be in flare in order to meet eligibility
  • Most patients in North America and Central Europe well-managed on current SOC
  • Only 2/7 legacy sites had recruited subjects – Only 30% of subjects enrolled when Innovaderm took over management
  • Non-recruiting sites did not have target patient population in current clinical practice
  • Global and regional Phase III trials competing for same population

Key Success Factors & Strategies

  • Country and site selection
  • PI Training
  • Site engagement
  • Regulatory Affairs
  • Study Branding

Conclusion

  • Extensive site and partner network: To identify the right sites in the right countries
  • Years of experience with dermatology sites: To assess and rank sites based on recruitment & data quality and to focus on the sites most likely to make a difference in recruitment & assure data quality

Within a month of the new sites opening in Europe and Asia:

  • Enrollment rates had more than doubled
  • None of the legacy sites contributed to new enrollment
  • Amid COVID, the Innovaderm team was able to activate two new countries in Europe and Asia, and complete enrollment faster than planned

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Is Now

We are excited to announce that Innovaderm is rebranding our CRO division as Indero (in-dAIR-oh). This rebranding reflects our ongoing commitment to innovation and our expansion into the field of rheumatology, a therapeutic area closely linked to dermatology. As a dual-focus CRO specializing in both dermatology and rheumatology, this strategic decision marks a significant milestone for our organization, and we are eager to embark on this new chapter with our valued partners and clients. Additionally, our Clinical Research Unit (CRU) will keep the name Innovaderm and will continue to conduct dermatology studies.

Site Selection & Management

Our long-standing relationships with key opinion leaders and highly performing sites, result in optimized start-up processes that deliver strong results in the least amount of time. As part of our site evaluation, our team utilizes past performance metrics, recruitment projections based on competitive landscape, and detailed feasibility surveys to determine a site’s capabilities and interest in a study.

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Patient Recruitment

Our dedicated patient recruitment and advertising team integrates with the study team to tailor recruitment strategies, customize central ad campaigns, develop advertising creative, and continuously track and adapt recruitment goals. Our patient-centric approach is enhanced by Clinago, our technology enabled recruitment service.

PROJECT MANAGEMENT

We orchestrate all study activities and deliverables, including site selection process, budget and contract negotiations, and patient engagement, recruitment enrollment projections, all while respecting your study timelines.

PROJECT MANAGEMENT

We orchestrate all study activities and deliverables, including site selection process, budget and contract negotiations, and patient engagement, recruitment enrollment projections, all while respecting your study timelines.