CRO Services

Tailored Excellence in Clinical Services

We offer comprehensive clinical trial support tailored to client needs, combining affordability with expert-led efficiency.

Life Sciences Landscape Challenges

Cost Efficiency

Facing financial constraints? Element offers cost-effective solutions to streamline research and development, enhancing value while lowering expenses.

Unified Data Approach

In our globally interconnected industry, data integration is a challenge. We emphasize data standardization as a pivotal business and regulatory tool.

Regulation Mastery

Tackle stringent global regulatory requirements with ease. Our proficiency in clinical data standards ensures your compliance and accelerates regulatory submissions.

Embracing Modern Tech

Harness the power of AI and machine learning in clinical trials. Element equips you with advanced tech solutions for comprehensive, data-informed trial management.

Your Trusted Partners in Trial Management

At Element, we are committed to ensuring your trial’s success. We bring deep insights into life sciences and leverage cutting-edge technology, delivering tangible business returns at reduced costs. Rely on us for clear, consistent updates on every facet of your trial with unparalleled transparency.

Our Services

Clinical Programming Services

At Element, we specialize in advanced clinical data solutions, with a mastery of CDISC standards. Our efficient, cost-effective offerings drive data standardization, regulatory compliance, and quality healthcare delivery.

Our Key Services:

  • Dataset Specifications, Creation, & Validation
  • PK/PD Calculation & Analysis Databases (ISS/ISE)
  • Comprehensive CDISC Services (SDTM, ADaM, Define.XML)
  • eCTD Support & Post-Marketing Data Analysis
  • Patient Profiles, Summaries, & Regulatory Assistance
  • Tables, Listings, Figures, & Edit Check Programming

Data Management Services

Element offers best-in-class Clinical Data Management, ensuring adherence to global standards like CDISC. We prioritize data integrity and quality, with a tailored approach for consistent processing.


Key Services Include:


  • EDC and Paper Trial Management
  • Diverse EDC Solutions (including Oracle)
  • Comprehensive Data Management Plans & Project Management
  • CRF/eCRF Design, Annotation, & Review
  • Database Design & Build
  • Efficient Data Processing & Query Management
  • Medical Coding & Safety Data Reconciliation

Biostatistical Services

With Element’s comprehensive biostatistical services, gain insights that stand up to regulatory scrutiny. We cover the full clinical development spectrum, from protocol design to regulatory submission.


Key Services Include:


  • Pre-Clinical Studies & Protocol Development
  • Randomization, SAP, & Output Designs
  • PK/PD Analysis & Detailed Reporting
  • Interim Analysis & DSMB Oversight
  • Meta Analysis & ISS/ISE Evaluations

Pharmacovigilance Services

Our suite of services prioritizes post-marketing drug safety and clinical surveillance.


Key Offerings Include:


  • Global Clinical & Post-Marketing Case Management
  • Medical Literature Tracking & Review
  • Comprehensive Safety Reporting (PSUR, DSUR, PADER, etc.)
  • Signal Detection & Benefit-Risk Analysis
  • RMP & REMS Strategies QPPV Services

Key Differentiators

SAS Excellence Hub

Leverage our SAS expertise for enhanced analytics, enabling smarter trial decisions and superior results.

Flexible Cloud Foundation

Benefit from our cloud platform—securing data access while achieving significant cost advantages over traditional setups.

Top-Tier Execution

Our in-house team guarantees swift, economical, and efficient trial conclusions, setting us apart in delivery proficiency.

Why Choose Element?

  • Personalized Service: Benefit from our agile, expert team delivering tailored solutions.
  • Tech-Savvy: Utilize a platform that simplifies workflows and enhances data-driven decisions.