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Early Phase & Translational Research Services

Indero supports phase 1, proof of concept (POC), first-in-human (FIH) single center and multicenter studies, as well as molecular characterization and mechanistic studies.

Meet Key Data Milestones With Early Phase Clinical Research

Operational excellence is crucial for early phase trials, as introducing your product into the clinical space marks a significant and critical milestone in your program’s development.

Indero’s team of dermatology and rheumatology experts excels in managing and conducting complex early-phase trials. We provide robust scientific and strategic support and have extensive experience in a wide array of study designs tailored to your specific needs.

of Early Phase/Translational Research
175 +
Investigators
2975 +
Indications
25 +

Early Phase Study Capabilities

Early phase trials mark your initial entry into the clinical space, where the primary goal is to evaluate the safety, tolerability, and efficacy of your investigational product or device. With Indero’s comprehensive experience in dermatology and rheumatology trials, we are the ideal partner for early phase studies that require precise methodological approaches and a deep understanding of immune-mediated conditions.

Partnering with us from the outset ensures that your initial steps are precise and well guided, paving the way for your successful trial and program development. And, as a true partner, our goal is to work with you from beginning to end throughout the development phases of your product.

We pride ourselves on being site- and patient-focused, ensuring every aspect of our early phase studies is designed with their needs in mind.

Focused on Subject Safety & Data Quality

  • Positive Site Experiences: Our sites enjoy working with us due to our exceptional service and support.
  • Comprehensive Site Support: We provide high-quality study materials and a one-stop-shop for material access, making it easy for sites to work with us. Our excellent service and support ensure that sites are well equipped and confident when conducting your trial.
  • Guidance in Study Design: Our expertise in study design during protocol development prioritizes site and subject experience. From the start, we focus on the operationalization of the protocol to ensure trial feasibility through site and patient engagement.
  • Proven Track Record: With 25 years of experience in managing and conducting early phase trials, we are leaders in this field. Our broad experience allows us to be agile, adapting and customizing our approach to the specific scientific and strategic needs of each study.

Clinical Capabilities

Indero has vast clinical capabilities to ensure quality early phase results. Our expertise includes complex design elements such as adaptive protocols, MOA, and PD/PK studies, multi cohorts, dose finding, tolerance, sensitization, intra-patient design, and more.

Scientific Expertise

Our scientific expertise—which includes nearly three decades of experience delivering immune mediated inflammatory disease studies—makes us an ideal partner for both dermatology and rheumatology early phase studies.

Global Reach, Local Presence

Indero operates on a global scale, with capabilities and relationships spanning North America, Europe, Latin America, and Asia Pacific. This means we can support you wherever you need to run your early phase studies.

Dedicated Clinical Research Unit (CRU)

Innovaderm, Indero’s CRU, holds vast experience and is strategically equipped to handle early phase and translational studies.

Focused on Subject Safety & Data Quality

We are data driven, ensuring efficient trial conduct and reliable data, while also offering a hands-on approach to training.

50+ Indications

Indero has the ability to run early phase studies, including basket trials, in over 50 indications across dermatology and rheumatology.

Early Phase & Translational Research Services

Indero offers clinical trial delivery solutions for early phase and translational research, helping to address the unmet needs of immune-mediated disease studies worldwide. Our services include:
  • Study design & protocol writing suited to the sponsor’s and trial’s requirements with strong scientific, medical, and clinical guidance.
  • Project management with experience managing early phase and POC trials, leading the way in innovative early phase designs, and combining agility with a data-driven mindset.
  • Document preparation & submission to regulatory and ethics boards ensuring an efficient review and approval process.

Dermatology Studies

Rheumatology Studies

Lisa Sherman

Sr. Director, Clinical Operations

Pelage Pharmaceuticals

“Indero’s flexibility and effective change management have been exceptional. They successfully integrated new study components, ensuring timelines were met and the project progressed seamlessly.”

Cutting-Edge Science

Early Efficacy Signals: Leading the Industry

  • Strategic Integration of Molecular Characterization: We guide sponsors to strategically integrate molecular characterization in their trials, increasing the value of their program and helping future funding cycles.
  • Expertise in Biomarker Research: Our experience conducting trials with multiple specimen types and analyses includes, but is not limited to, tape strips, single-cell transcriptomics, RNASeqM, proteomics, lipidomics, microbiome, PBMC, sequencing, and expression profiling.
  • Imaging Expertise: Advanced imaging techniques, including DermaScan, high-resolution photography (including Visia-CR and LifeViz), Optical Coherence Tomography (VivoSight), etc. to support trial outcomes.
  • Comprehensive Training and Quality Samples: In-depth experience working with multiple partners to create comprehensive training materials and support operational logistics on sample quality and chain of custody.

Dermatology & Rheumatology Indications for Early Phase Studies

Indero can support early phase and translational studies across a wide range of dermatology and rheumatology indications. Here are some examples of indications we focus on:

  • Atopic dermatitis
  • Psoriasis
  • Alopecia areata
  • Hidradenitis suppurativa
  • Chronic inducible urticaria
  • Chronic spontaneous urticaria
  • Vitiligo
  • Acne
  • Rosacea
  • Chronic hand eczema
  • Notalgia paresthetica
  • Actinic keratosis
  • GPP, PPP and PPPP
  • Hyperhidrosis
  • Prurigo nodularis
  • Onychomycosis
  • Rheumatoid arthritis
  • Osteoarthritis
  • Radiographic (ankylosing spondylitis) and non-radiographic axial spondyloarthritis
  • Psoriatic arthritis
  • Systemic lupus erythematosus (SLE) and juvenile SLE
  • Lupus nephritis
  • Idiopathic inflammatory myopathies, including polymyositis and dermatomyositis
  • Sjögren’s disease
  • Systemic sclerosis (scleroderma)
  • Osteoporosis

Atopic Dermatitis Phase 1 Study Successfully Detects Efficacy Signal

Indero successfully managed a phase 1 clinical trial testing a systemic (oral) treatment for atopic dermatitis (AD). The study included both healthy participants and those with AD, utilizing a FIH single dose escalation and multiple dose escalation (SAD/MAD) design (n=72) and a proof-of-concept (PoC) cohort (n=31). Conducted across 12 sites in the U.S. and one in the Netherlands, the study procedures included biopsy, tape stripping, and PK. 

Challenges

  • Multi-Cohorts:
    • SAD/MAD: Several cohorts for a total of 72 subjects
    • Phase 1 unit management: Located in the Netherlands
    • PoC: Max dose selected, 31 AD subjects
  • Challenging Inclusion Criteria:
    • Patients with severe AD (high BSA and IGA scores) required
    • Short treatment duration (4 weeks)
  • COVID-19 Pandemic:
    • Impacted PoC recruitment

Highlights

  • Detection of an Efficacy Signal in Early Phase: Signal detected in a sample size of 31 subjects, moving the program to Phase 2
  • Targeted Site Selection: Selection of interested and engaged sites in this early phase study
  • Efficient Start-up Period: Effective, seamless, and on-track study set-up
  • High Study Visibility: This successful study was published in a peered-reviewed journal

FAQs

Subject safety and data quality are foundational to every early phase study. From protocol development through execution, we take a site- and patient-focused approach to ensure trials are both feasible and rigorously controlled. Our teams provide comprehensive site support, including high-quality study materials, hands-on training, and clear operational guidance. At the same time, our data-driven oversight enables early identification of risks, protects participants, and ensures reliable, high-quality data. 
Dive Deeper Into Our Early Phase Approach
Indero supports a wide range of early phase study designs tailored to the scientific and strategic needs of each program. Our experience spans both traditional and innovative methodologies commonly used in dermatology and rheumatology research.  Key areas of expertise include: 
  • First-in-human (FIH) studies and proof-of-concept (POC) trials  
  • Basket study and disease characterization/mechanism of action (MOA) 
  • Dose escalation models, including single ascending dose (SAD), multiple ascending dose (MAD), and proof of concept (POC) cohorts  
  • Adaptive protocols and multi-cohort studies  
  • Intra-patient and tolerance/sensitization designs 
  • Maximum-use studies (MUsT/MUSE)  
  • Single- and multi-center study designs 
See How Indero Supported a Phase I AD Study
Indero integrates translational research strategies into early phase trials to help sponsors better understand disease mechanisms and treatment effects at a molecular level. By incorporating biomarker research and molecular characterization into study design, we help generate insights that strengthen clinical development programs and support future decision-making. Our expertise includes working with diverse specimen types and advanced analytical techniques, as well as coordinating the operational logistics required to ensure sample quality and chain of custody. 
Indero combines operational agility with strong clinical and scientific guidance to support sophisticated study designs. Our capabilities include adaptive trial designs, pharmacokinetic (PK) and pharmacodynamic (PD) studies, molecular characterization, mechanism of action (MOA), and advanced imaging techniques to support endpoint evaluation. We also support multi-cohort and dose-finding studies, ensuring efficient progression from early safety assessments to proof-of-concept.   With dedicated infrastructure, including a specialized clinical research unit, and nearly three decades of experience in immune-mediated diseases, Indero is well equipped to manage the complexity of early phase trials while maintaining speed, quality, and scientific rigor. 

Wherever You’re Going,
We’re all in.

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