Quality, Integrity and Accountability in Clinical Research
At IDDCR Global Research, quality, data integrity and responsible handling of clinical research information are important considerations in our service delivery. We aim to support reliable, traceable and well-documented clinical research processes through appropriate procedures, defined responsibilities and quality oversight aligned with the requirements applicable to each engagement.
Our Quality Approach
Quality Management
We emphasize documented processes, defined responsibilities, review activities and appropriate quality oversight in the delivery of our services.
Data Integrity
We recognize the importance of data accuracy, completeness, consistency, traceability and appropriate access controls throughout the data lifecycle.
Documentation and Traceability
We aim to maintain appropriate records of relevant activities, decisions, reviews and changes in accordance with the procedures and requirements applicable to each project.
Risk-Based Oversight
We support proportionate risk assessment, issue escalation and corrective or preventive actions where appropriate to the scope of the engagement and applicable procedures.
Aligned With Applicable Clinical Research Requirements
Clinical research requirements vary according to the study, sponsor, jurisdiction, service scope and systems involved. Our approach takes account of applicable requirements and agreed sponsor expectations relevant to each engagement.
Where relevant to the project, this may include consideration of:
Applicability of the above depends on the specific engagement, contracted scope and the controls actually implemented for each project.
Service-Specific Quality Considerations
Clinical Data Management
Our clinical data management services emphasize documented data review, query management, data reconciliation, traceability and quality checks, where included in the contracted scope.
Biostatistics and Statistical Programming
We emphasize review of analysis specifications, programming quality checks, reproducibility, documentation and appropriate independent review, where applicable to the engagement.
Pharmacovigilance
Our pharmacovigilance services emphasize appropriate case-processing procedures, data quality checks, documentation, escalation and reporting timelines according to the applicable requirements and contracted responsibilities.
Clinical Research and Trial Support
We emphasize documented responsibilities, study-specific procedures, oversight and appropriate records according to the agreed scope of each engagement.
Healthcare AI and Technology
Our AI and technology services emphasize appropriate data governance, access control, testing, documentation, human oversight and risk assessment as applicable to each product and deployment. AI-generated outputs require professional review and are not represented as validated for regulated use without documented evidence.
Transparent, Documented and Scope-Appropriate Quality Practices
Quality documentation and supporting evidence are maintained or developed according to the service scope, project requirements and applicable procedures. Relevant documentation may be made available to prospective clients through an appropriate due-diligence process, subject to confidentiality, availability and contractual requirements.
Discuss Quality RequirementsPotential materials for due-diligence review
Availability of specific documentation is subject to confidentiality, contractual requirements and the scope of the engagement. Not all materials listed above may be available for every project.
Let's Discuss Your Quality and Compliance Requirements
We welcome discussions with sponsors, CRO partners and research organizations about project-specific quality expectations, documentation requirements, data governance and service responsibilities.
Contact Our Team