Empowering
life science with
data-driven decisions

Leveraging
data science to spark
clinical breakthroughs

We are a biometrics Clinical Research Organization (CRO) that helps leading life science companies unlock the power of clinical data. Our team of data science professionals has substantial experience in the regulatory, statistical, and data management spaces operating across a broad range of therapeutic areas along the entire drug development pipeline. With a focus on transparent and flexible engagement models, Intego Clinical can effectively and efficiently handle all your outsourcing needs as a global full-service CRO.

Services & Expertise

Statistical Programming

We provide comprehensive end-to-end services, from Phase I to post-marketing, in all major therapeutic areas, and we comply with all regulatory global standards. Our attention to detail and willingness to problem-solve make us the ideal partner for your clinical studies.

  • Programming support for global Phase I-IV studies
  • Meet client’s metrics for time and quality
  • Implement client’s standards and procedures
  • Regular communication to keep process flowing smoothly

Data Management

We help our clients get the most out of their clinical data with innovative and accurate data management solutions. Our experienced data specialists are experts in various data collections and reporting systems used throughout Phase I-IV studies.

  • Strict adherence to ICH, GCP, and FDA 21 CFR Part 11 regulations, as well as client-defined SOPs
  • Extensive internal quality control and data validation
  • Commitment to internal training and professional development

Biostatistics

We’ve successfully brought many drugs in all main therapeutic areas to market over the years. From study conception to analysis and regulatory submissions, we help our clients get the most impact and insights from their clinical studies.

  • Ideal sample size calculations
  • Analysis plans
  • Modeling and simulation
  • Interpretation of results
  • Data visualization
  • Identifying non-obvious dependencies
  • ISS and ISE study design

Medical Writing

We produce clear and consistent documents for clients at every stage of the clinical development process. Our experienced team of medical writers creates regulatory submissions, patient and investigator brochures, and study reports for clients across all major therapeutic areas.

  • Protocol development
  • Informed consent forms
  • Study design
  • Investigator brochures
  • CSRs
  • EMA and FDA briefing packages
  • Periodic safety update reports
  • Abstracts and posters

Software Engineering

We bring software engineering talent from different industries to deliver creative solutions in the clinical setting. Our IT experts come from a variety of industries, bringing fresh perspectives to challenges in software development.

  • 15 years of software engineering excellence
  • Full-cycle application development
  • HIPAA-compliant applications
  • Enterprise analytics
  • Cloud-based applications
  • Legacy systems migration

CDISC Migration

We specialize in all aspects of regulatory data compliance and migration strategies. No matter the size and scope of the project, Intego Clinical can map your current or legacy data to all major CDISC formats and advise on adherence to industry standards.

  • Mapping of current or legacy data to CDISC standards
  • Recreation of SDTM, ADaM, etc.
  • Regulatory submission packages and ISS/ISE reporting
  • Recreation of Tables, Listings and Figures (TLFs)
  • Customized data solutions

Data science
for pharma R&D

Accelerated insights
generation
TOPOLOGICAL DATA
ANALYSIS
CLINICAL DATA SCIENCE
PLATFORM
OUR TEAM OF DATA
SCIENTISTS

Accelerated insights generation and real-world analytics

We help pharma companies and CROs generate evidence that complements traditional randomized clinical trials and observational studies. Our geometric, data-driven approach combines biostatistics, topological data analysis, machine learning, and data visualization for unveiling hidden patterns in complex clinical datasets.

Topological data analysis for complex clinical studies

Topological data analysis (TDA) has been applied in different branches of bioinformatics, epidemiology, neuroscience, and oncology with promising results. TDA methods are used to detect and display robust relationships hidden in complex datasets.

Atlas-TDA: Clinical data science platform

Atlas-TDA, our HIPAA-compliant data science web-based application, enables researchers to extract topological models from complex clinical datasets. With it, users can perform visual explorations of hidden relationships within a set of interrelated clinical outcomes.

A team of data scientists with strong industry expertise

Using a wide range of technologies, including Python, R, SAS, R-shiny, and more, we employ modern machine learning algorithms, advanced statistical methods, and data visualization techniques to solve the most challenging problems faced by the pharma industry.

10+ years
experience in clinical research
96%
employee retention rate
Tier 1
vendor for big pharma
Phase I-IV
proven expertise

Therapeutic Areas

1 / 4

Engagement Models

Secure the best talent based on your unique needs and requirements

The Functional Service Provider (FSP) model has become industry best practice for outsourcing because it allows clients to operate in a cost-effective and agile manner while retaining control of the clinical trial, day-to-day project operations, and access to clinical data. Using the FSP model and following your SOPs and internal processes, we seamlessly integrate data science professionals with your existing teams and project workflow.

Benefits of using a functional service provider:

  1. Lower clinical development cost
  2. Global strategic reach
  3. Flexible customized solutions
  4. Control, visibility and leadership
Tier 1
FSP vendor for big pharma

One-stop-shop solutions that don’t compromise on quality

Choosing Intego Clinical as your full-service global CRO will lower the total cost of your biometric services without compromising quality or efficiency. Our company has offices in Eastern Europe and Central Florida, allowing us to staff project teams in a strategic and cost-efficient manner. Our full-service solutions provide you with a single biometric CRO, reducing inefficiencies that can be generated by multiple outsourcing partners.

Benefits of full-service solutions:

  1. Predictable cost of clinical project(s)
  2. One-stop-shop arrangement
  3. Potential project cost savings
  4. Simplified contractual agreement
96%
Team retention rate

Agile solutions to help keep your trial deliverables on time

Unit-based services enable our pharma and CRO clients to completely outsource smaller work packages to Intego Clinical. Our unit-based model is a cost-effective way for you to meet your project goals and keep track of expenditures. Unit-based solutions minimize disruptions to your trial(s), ensuring reliable budget estimations and timelines while maintaining the ability to incorporate scope changes.

Benefits of a unit-based model:

  1. Cost-effective solution
  2. Concentration on core activities
  3. Fast response to change
  4. Projects stay within scope and under budget
SCRUM
Agile methodology ensures timely delivery

Building on our successful track record of innovation and expansion

Intego Clinical is a biometrics CRO with longstanding success in recruiting and training talent in global markets. Through our world-class training programs, experience building biometrics services from the ground up in new geographic regions, and development of proprietary AI/ML data visualization tools, we’ve become a trusted partner for leading pharmaceutical companies and global CROs.

Main areas of consulting:

  1. Biostatistical consulting
  2. Expansion into new regions
  3. Training programs in partnership with universities
  4. Emerging AI/ML technologies and real-world analytics
10+ years
Experience in clinical research

How to get started

Your company
Therapeutic areas (pick multiple)
Workforce estimate to cover your needs
Your business needs (pick multiple)
Type of engagement