Your partner for Dx compliance in translational research

Scientist talking

Your CRO partner with a difference

Managing your CRO clinical studies from start to end.

Different from generic CROs, our focus is on supporting in vitro diagnostics (IVDs).

This specialisation equips us to guide you through from strategy to delivery of your project.

Our in-depth knowledge ensures that regulatory considerations are integrated into performance study planning, fortifying both regulatory submissions and market launch strategies.

Clinical Operations: Comprehensive Study Management

Driving CRO clinical studies with essential documentation, ethical guidance, and test site monitoring support.

Ensuring your study’s success requires good documentation practices and steadfast ethical considerations.

We provide this foundation and maintain vigilant monitoring support throughout:

Providing essential documentation development underpinning your study's needs.
Assisting in the development of ethically compliant submissions.
Continuous support throughout the project's lifecycle.
Medical consultants

Site Selection, Contracting & Management: Quality Data Delivered On-Time

The right study site is pivotal to garnering precise data and achieving timely study conclusions.

Our expertise allows us to identify, contract, and manage these sites on your behalf:

Leveraging our expertise to select and engage sites that align with your study's requirements.
Streamlined processes for efficient contract handling and management.
Scientists testing

Compliance & Regulatory Support: Tailored IVD Expertise

Navigating the intricate world of IVD regulations is challenging.

Our comprehensive expertise ensures your studies are aligned and compliant:

Benefiting from our in-depth understanding and experience in IVD regulations and regulatory compliance.
Ensuring your studies align with the current regulatory and compliance processes.
Patient being tested

Protocol Strategy & Design: Customised Clinical Research Solutions

Each study is unique, demanding a distinctive approach.

We develop protocols designed to specific regulations and therapeutic areas:

Aligning strategies tailored to your study, helping to maximise the value in the data set.
Ensuring alignment with specific regulatory needs.
Scientists and consultants talking

Data Management: Efficient Analysis and Reporting

Streamlining and managing a study data requires expertise.

We provide the knowledge and industry standard e-tools to ensure the collection of a robust data set:

Using your study specific requirements to develop the corresponding EDC/eCRF to capture and manage your data set.
Implementing industry-best standards for consistent data management.
Scientist typing

Statistical Services: Expert Biostatistics Support

Customised biostatistical assistance across diverse therapeutic areas.

Data alone does not tell the story. We interpret data, providing you with insightful biostatistical perspectives:

  • Custom Biostatistics: Leveraging our expertise for tailored statistical insights, ensuring the power of your data set complies with regulatory requirements and maximises value across regulatory geographies .
  • Therapeutic Area Partnerships: Collaborating across various therapeutic areas for comprehensive support.
DNA String

Get in touch with our expert team today