Specialized Biometrics
Boutique

Customized Stand-Alone Solutions

Redefining excellence in biostatistics and data management

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Comprehensive Biometrics Back-End Solutions

Biostatistics

Adaptive design

Strategic statistical consulting

Simulation support

Handling of missing data

Support with regulatory authorities' questions 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)

Data Management

Database design

Data validation, review and cleaning

Medical coding

Data consolidation and reconciliation

Data migration and conversion

Proprietary quality control tools

Dr. Christian Marsolais

Senior Vice President and
Chief Medical Officer
Theratechnologies
www.theratech.com

“We achieved our oncology research goals with Diane Potvin’s creative and robust statistical solutions”

In our long-standing collaboration with Diane Potvin (Senior Statistical Advisor, Innovaderm), she has proven to be a very professional, innovative, and capable biostatistician. Her support and expertise in biostatistics and oncology have been invaluable in moving our phase I clinical oncology program forward. She is always very adaptable and responsive to our requests, works well with our Thera team, and was able to quickly provide sound advice on how to develop a novel dose-escalation algorithm, supported by the binomial distribution, that was readily accepted by the FDA. Her input allowed Thera to seamlessly explore different dosing schedules/strategies in the ongoing phase I trial. We look forward to a continued partnership with Diane.

Crafting the future of biometrics, datum by datum

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Paving the way: Client Success Story

Turning the Tide: A Remarkable Turnaround in Phase 2 Trial Results

The Challenge

A client shared disappointing phase 2 trial results and FDA’s stern comments on phase 3 protocol (developed by another CRO).

Our Solutions

We meticulously reviewed phase 2 study data and conducted post-hoc analysis, identified phases 2 and 3 design flaws and completely revamped phase 3 statistical portion of protocol and statistical analysis plan (SAP).

The Results

Our rigorous re-evaluation yielded significant phase 2 results, surpassing expectations. We helped overcome hurdles, instilling renewed confidence in the drug’s potential to phase 3.

Therapeutic knowledge and experience

Deep biometrics insights into a wide range of therapeutic areas

+200

Studies with biostatistics and/or data management

Crafting the future of biometrics, datum by datum

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Over 3 decades of unparalleled biometrics services​

45+ Skilled Biometrics Professionals​

Pina D’Angelo​​

VP, Biometrics

Diane Potvin​​​

Senior Statistical Advisor​

Eric Hardy​​

Senior Director Biometrics​

Edith Simeon​​

Associate Director Biostatistics​

Rolland Gaudet​​​

Principal Biostatistician​

01

Memberships

02

Accreditations

03

Publications

Cutting-Edge Technologies

Established Qualified Vendors

RTSM EDC
Medidata
Medrio
Veeva
Signant Health
Suvoda

Awards & Successful Regulatory Compliance

Experience the
Innovaderm Edge

Reliability

Over 30 years of experience in meeting sponsor expectations with consistency, dependability, and quality of the biometrics services.

Precision

CRF forms library and EDC edit checks meticulously flagging discrepancies. Intricately planned study design, SAP, and randomization schedules.

Collaboration

45+ DM and Biostatistics team members working closely, ensuring seamless data transition, quality, and timely delivery of study results.

Expertise

Experts in navigating complicated study designs in every trial phase, from study design to regulatory submissions and using innovative data analysis techniques and methodology.

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