webinar
25/01/2024
Companion Diagnostic Development: What To Plan For And Why It Matters
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.
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.
Identifying optimal sites to ensure robust data generation and timely results
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.
Supporting your studies with a robust QMS process and up-to-date regulatory compliance insights
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.
Meeting your specific regulatory and therapeutic area needs
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.
Designing and implementing data capture to collect your data
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.
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