
Specialized Biometrics
Boutique
Customized Stand-Alone Solutions
Redefining excellence in biostatistics and data management
Contact UsComprehensive 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

“Our collaboration has been nothing short of exceptional”
Working with Innovaderm was an absolute pleasure. Their expertise and commitment were particularly evident when data or analysis related challenges arose. Innovaderm consistently provided multiple solutions and well thought out strategies to handle these complex situations. Their team's quality of work, flexibility, and straightforward communication made our partnership and workstreams smooth and efficient. We appreciated the lack of unnecessary back-and-forth, with most cases being resolved without the need for lengthy email threads. This efficiency enabled us to achieve our desired timelines with high-quality deliverables. Overall, our experience with Innovaderm was highly positive. I have had the opportunity to work closely with Innovaderm teams on several projects over the past few years. We would definitely collaborate with them again and wholeheartedly recommend their Biometrics services.


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
Contact UsOver 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


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.




Cutting-Edge Technologies
Established Qualified Vendors
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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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