Biotech & Pharma

QNTILO – Clinical biostatistics consultancy company.

Let's talk about QNTILO – Clinical biostatistics consultancy company.

Founded on January 13, 2025, QNTLO is a clinical biostatistics consultancy company.

We specialize in providing comprehensive biostatistical and statistical programming services for Phase I and Phase II clinical trials. Our primary objective is to assist clients in selecting the most appropriate dose for their Phase III studies. By offering integrated support during the early stages of clinical development, we enable clients to make data-driven decisions that optimize efficacy and safety outcomes, increasing their likelihood of performing successful phase 3 clinical trials.

We offer end-to-end support, from study design through data analysis, ensuring all early-phase activities are aligned with the goal of optimal dose selection.

Established by Juan Vicente Torres, a statistician with over 20 years of experience in clinical research, the company embodies a wealth of expertise and a deep understanding of the industry’s complexities.

Our vision is to operate as a niche clinical services company that prioritizes quality over quantity. By intentionally maintaining a small team, we ensure that each project receives meticulous attention and that our clients benefit from direct access to our experts. This approach fosters an environment where communication is seamless, teams are fully integrated, and everyone is intimately aware of ongoing projects and company objectives.

Biostatistical Consulting

Clinical development plans
Study design and planning including adaptive designs
Advice on study objectives, endpoints, and hypotheses
Sample size calculation and power analysis
Statistical simulations to assess design properties and operating characteristics
Clinical study protocol writing support

Statistical Analysis

Statistical analysis plan writing
Identification of analysis sets
Mock tables, figures, and listings (TFLs)
Final and interim analysis

Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis

Modeling and simulation
Performing PK/PD modeling to understand drug behavior
Supporting dose selection and optimization
Non-compartmental analysis
Compartmental analysis
Population pharmacokinetic (PopPK) analysis

Statistical Programming

Programming of SDTM and ADaM datasets according to CDISC standards
Generation and validation of TFLs
Generation of patient profiles for data review activities
Automating report generation for efficiency and accuracy
Data visualization
Automation of statistical processes

Clinical Study Reports (CSR)

Writing and reviewing the statistical methods and results sections
Ensuring clarity, accuracy, and compliance with ICH E3 guidelines

Regulatory Submission Support

Preparing documentation for regulatory agencies (eg, FDA, EMA)
Assisting with responses to regulatory queries regarding statistical analyses

Data Monitoring Committee (DMC) Support

Interim analysis preparation
Conducting interim analysis for safety, efficacy and sample size reassessment
Preparing reports for DMC meetings while maintaining data blinding
Independent statistical support

Training and Workshops

Statistical training for clinical teams
Providing training sessions on statistical concepts and methodologies
Software training

Quality Control and Validation

Independent review and validation of statistical analyses and programming code
Conducting audits to ensure compliance with guidelines
Process improvement consulting
Gap analysis

Medical Writing Support

Manuscript and publication support

Contact with QNTILO – Clinical biostatistics consultancy company.

QNTILO – Clinical biostatistics consultancy company.

Website: https://qntlo.com

Address: Parc Bit, Galileo Galilei, 2. 07121 Palma, Spain.

E-mail: jvt@qntlo.com