INNOVADERM CRO IS NOW INDERO.

Clinical Biostatistics & Data Management

Comprehensive back-end biometrics services for any clinical trial in any indication.

Memberships, Accreditations & Publications

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society for clinical trials logo
journal of allergy and clinical immunology logo
BS medidata logo
allergy european journal of allergy and clinical immunology logo

About Our Biometrics Services

Indero’s biometrics services integrate custom data management and biostatistics to handle complex study designs.

  • 100% of databases built on time
    (as expected by the sponsor) and before the screening starts
  • 100% of databases locked on time, with toplines results delivered within 5 business days 
  • Data managers, statistical and clinical data programmers, and biostatisticians working closely under one umbrella
  • Complete team with the capacity to manage data builds, database locks and statistical analysis
  • Experience working with qualified RTSM and EDC vendors, including Medidata, Medrio, Veeva, Signant Health, and Suvoda 
  • Blinded dry run(s) during the study
  • CRF forms library and EDC edit checks meticulously flagging discrepancies 
  • Intricately planned study design, SAP, and randomization schedules

Deep Therapeutic Knowledge & Experience

Indero offers deep biometrics insights into a wide range of therapeutic areas, including cardiology, oncology, CNS, respiratory, ophthalmology, rare diseases, endocrinology, dermatology, rheumatology, and gastroenterology. 

End-to-End Data Management & Biostatistics Services

Data Management

  • Database design
  • Data validation, review, and cleaning
  • Medical coding
  • Data consolidation and reconciliation
  • Data migration and conversion
  • Proprietary quality control tools
  • Support fast enrollment targets

Biostatistics

  • Adaptive design
  • Strategic statistical consulting
  • Development of estimands
  • Simulation support
  • Handling of missing data
  • Support with addressing regulatory authorities’ inquiries and meeting representation
  • Sample size and power calculations
  • Randomization schedule
  • Statistical analysis plan (SAP)
  • Interim analysis
  • Data safety monitory board (DSMB)
  • CDISC (SDTMs and ADaMs)
  • Production of concise statistical tables, listings and figures (TLFs)
  • Integrated summary of safety (ISS) and efficacy (ISE)

Regulatory Compliance & Awards

CRO leadership award badge 2024
HIPAA compliant
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FDA logo
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European Medicines Agency logo
EU clinical trials register

Partner with Our Biometrics Team

For 25 years, our biometrics services have consistently been exceeding sponsor expectations with reliability, quality, and expertise. We handle complex study designs across all trial phases, utilizing innovative data analysis techniques and methodologies. Share your data management and biostatistics needs with us today. 

A Remarkable Turnaround in Phase II Trial Results

Following disappointing results from a phase II CNS trial handled by another CRO, Indero performed a rigorous review of the statistical methodologies and programming algorithms used to analyze the study data, identified flaws, and performed a post-hoc analysis addressing these flaws appropriately yielding statistically significant results and instilling renewed confidence in the drug’s potential for phase III.

Challenge

  • Disappointing phase II trial results (handled by another CRO) 
  • Received stern comments from the FDA on their phase III protocol and statistical analysis plan (SAP) (developed by an independent consultant)

Strategy

  • Meticulously reviewed statistical analysis of phase II study data as well as phase III protocol and SAP 
  • Identified flaws with design of each study
  • Conducted post-hoc analysis of phase II data 
  • Completely revamped phase III statistical portion of protocol and SAP

Meet a Selection of Our Biometrics Experts

Biometrics Services that Accelerate Studies

Scientific discipline. Operational efficiency. Clinical development expertise. Our back-end data management and biostatistics solution provides the rigorous foundation, quality data and expertise clinical trials need to ensure effective execution and on-time delivery.

“We would definitely collaborate with them again and wholeheartedly recommend their biometrics services.” 

Kye Gilde head shot

Kye Gilder

Senior VP, Biometrics at Ventyx Biosciences

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Wherever You’re Going,
We’re all in.

Need help with your next study? We want to learn more. Fill out the form on the right and one of our experts will be in touch.

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. Innovaderm will continue to operate as a CRU for 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.