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TRUSTED BY PHARMA & BIOTECH FOR STATISTICAL & DATA EXPERTISE

Bring your drugs to market with fast and reliable access to experts from one of the world's largest global biometric Clinical Research Organizations.

Statistical Analysis, Data Capture and Clinical Trial Reporting

BIOSTATISTICS

BIOSTATISTICS

Understand your drug's/device's efficacy and safety profile with expert statistical analysis of your clinical research data.
STATISTICAL PROGRAMMING

STATISTICAL PROGRAMMING

Turn un-interpretable validated clinical data into something meaningful with clinical trial reporting to make informed decisions and submission ready deliverables.
CLINICAL DATA MANAGEMENT

CLINICAL DATA MANAGEMENT

Flexible and modern data collection, capture and management methods for your research data to ensure error free and timely database locks in line with the latest regulatory guidance.
BIOSTATISTICAL CONSULTANCY

BIOSTATISTICAL CONSULTANCY

Ensure efficient trial designs, analysis and study planning to streamline your clinical development efforts to reduce costs and save time.

The three steps to a faster drug approval

Schedule a meeting and speak with a clinical data expert

Specify your needs and requests.

A bespoke plan will be created in line with your needs

Best data practices determined for your studies and budget determined.

Our Clinical Data Experts become a part of your team

You receive high-quality clinical data outputs.

Our Areas of Expertise:

Protocol Design and Power Calculations

Get the right protocol design for the right scientific questions of your trial and boost the chance of success with sound sample size calculation.

CDISC/ADaM Mapping

Convert all your trial research data into one globally regulatory recognized data standard for clinical research.

EDC & Data Capture Options

Utilize the latest data capture technologies such as wearable and ePRO devices and take a flexible approach to selecting the right electronic data capture (EDC) system for your trial.

ISS/ISE Support

Overcome the challenges of combining multiple studies to review the safety and efficacy of an IND/NDA.

Centralized Statistical Monitoring & Data Quality Oversight

Help assure that your regulatory submission isn’t needlessly delayed through a lack of data quality or integrity as you discover data anomalies, outliers and other unnoticeable trends to improve the chance of your regulatory approval.

Clinical Study Designs/Adaptive Trials

An optimally designed trial can reduce costs and save time, either by requiring a smaller sample size or by stopping a trial earlier in time without continued wasted efforts.

PK/PD Services

Get the specialist software and expertise you need to discover what the body does to your investigational drug and where it goes with Pharmacokinetics (PK) and Pharmacodynamics (PD) analysis.

Clinical Data Visualizations

Gain early insights into your pre-database lock data with free Tables, Listings and Figures visualizations to give you an idea of the potential trial reporting results that lay ahead.

Oncology

Oncology trials face many challenges in the collection, analysis and reporting of study data, and selecting a partner that is specializes in data instead of a traditional full-service CRO can make all the difference in your studies success.

Select your preferred resourcing model

Functional Service Provision

Functional Service Provision

Gain rapid access to resource of functional biometric teams and become flexible to any peaks and troughs in your pipeline.

Fixed Cost Projects

Fixed Cost Projects

Gain resource on a single project by project basis for the biometric support you need, when needed.

Utilize Contractors

Utilize Contractors

Handle a single or multiple contracts and the convenience of adding additional resources on a smaller scale.

What Our Clients Say

FREE WHITEPAPERS & WEBINARS

Resources to a successful drug approval