Quality & Governance
Quality and governance are fundamental to responsible clinical research delivery.
Orizzonte’s approach is designed to support participant safety, regulatory compliance, data integrity and consistent operational standards across the research activities it supports.
Quality as part of research delivery
Built into the approach
Quality and governance should not sit separately from research delivery.
Within the Orizzonte model, governance and quality oversight form part of the infrastructure supporting appropriate research delivery across the network.
The objective is to support research that is conducted with appropriate attention to participant safety, regulatory requirements, data integrity and operational consistency.
Four Priorities
The Principles
Four priorities guide everything we do, ensuring research is delivered safely, compliantly and consistently across our network.
Participant Safety & Rights
Research delivery should protect participant safety, dignity, rights and informed choice.
Regulatory Compliance
Research activities should be conducted in accordance with the regulatory, ethical and study-specific requirements applicable to the research.
Data Integrity
Research information should be managed in a way that supports accuracy, reliability and appropriate handling.
Consistent Operational Standards
Research delivery should be supported by clear expectations and appropriate oversight across the network.
Governance should reflect the study
Study-Specific by Design
Clinical studies differ in their protocol requirements, risk, procedures, delivery settings and organisational responsibilities.
Governance should therefore be considered in the context of the individual study and the role of each organisation involved.
Where research proceeds, relevant requirements and responsibilities are established through the appropriate study-specific arrangements.
Consistency across the network
Supporting consistent research delivery
Where a study involves more than one Orizzonte location, central coordination and governance oversight are intended to support common operational expectations across the network.
The requirements of the individual protocol remain central to how each study is delivered.
Research starts with the participant
Responsible research requires more than operational delivery.
People considering research participation should receive appropriate information and be able to make informed, voluntary decisions about whether participation is right for them.
Orizzonte’s approach places emphasis on:
- participant safety;
- dignity and respect;
- informed choice;
- voluntary participation;
- appropriate communication; and
- protection of confidential information.
Due diligance
Need More Detail?
Sponsors, CROs and healthcare partners may need more detailed information about Orizzonte’s governance, quality systems and operational arrangements during feasibility, due diligence or partnership discussions.
Appropriate information can be shared through the relevant controlled process.
Frequently Asked Questions
Quality and governance form part of Orizzonte’s research-delivery approach and are intended to support participant safety, regulatory compliance, data integrity and consistent operational standards.
No. They depend on factors including the protocol, study design, delivery setting and the responsibilities of the organisations involved.
No. Responsibilities remain determined by the applicable regulatory, organisational and study-specific arrangements.
Where research involves multiple locations, central coordination and governance oversight support common operational expectations while maintaining study-specific requirements.
Yes. Appropriate information can be discussed through feasibility, due diligence or study-specific processes.
Discuss Research Delivery With Orizzonte
If you are considering a study that may fit the Orizzonte network, talk to our team about the study, its anticipated delivery requirements and relevant governance considerations.