INNOVADERM CRO IS NOW INDERO.
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Clinical Biostatistics & Data Management

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

Biometrics Professionals

0 +
Studies Supported with Biometrics Services
1 +
Years of Experience
5 +

Memberships, Accreditations & Publications

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 topline 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

Partner with Our Biometrics Team

For over 25 years, our biometrics services have consistently exceeded 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. 

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A Remarkable Turnaround in Phase 2 Trial Results

Following disappointing results from a phase 2 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 3.

Challenge

  • Disappointing phase 2 trial results (handled by another CRO) 
  • Received stern comments from the FDA on their phase 3 protocol and statistical analysis plan (SAP) (developed by an independent consultant)

Strategy

  • Meticulously reviewed statistical analysis of phase 2 study data as well as phase 3 protocol and SAP 
  • Identified flaws with design of each study
  • Conducted post-hoc analysis of phase 2 data 
  • Completely revamped phase 3 statistical portion of protocol and SAP

Meet a Selection of Our Biometrics Experts

Pina D'Angelo

Global Head, Data & Regulatory Sciences

Diane Potvin

Senior Statistical Advisor

Eric Hardy

Senior Director Biometrics

Edith Simeon

Director Biostatistics

Rolland Gaudet

Principal Biostatistician and Biometrics Strategy Lead

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 that clinical trials need to ensure effective execution and on-time delivery.

ABOUT INDERO

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

Kye Gilder

Senior VP, Biometrics at Ventyx Biosciences

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.

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Jeff Smith

Chef de la direction

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.

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.