CRO Capabilities & Project Delivery
Your Clinical Research Partner for Data, Science and Delivery
Your Clinical Research Partner for Data, Science and Delivery
Integrated clinical research and biometrics capabilities supporting clinical data management, biostatistics, statistical programming, CDISC standards and pharmacovigilance.
IDDCR Global Research works with organisations seeking flexible clinical research support, clearly defined project responsibilities, documented deliverables and structured communication throughout project execution.
Our CRO Capabilities
What We Can Support
Each capability below describes the scope, typical deliverables, project workflow and quality approach for that service. Specific scope is agreed in the statement of work for each project.
Clinical Data Management
IDDCR Global Research provides clinical data management support across the data lifecycle, from study start-up through database lock. Our team works to agreed specifications, documented procedures and project-specific quality requirements.
Scope of Support
Data management planning; CRF and eCRF design review and annotation; data review and discrepancy management; query generation and resolution; external data reconciliation; coding support (MedDRA, WHO Drug); database lock activities.
Typical Deliverables
Data Management Plan (DMP); annotated CRF; data review listings; query log; reconciliation report; database lock documentation; data transfer package.
Project Workflow
Kick-off and requirements review → DMP development and approval → database build review → data entry and ongoing review → query management → reconciliation → database lock → data transfer.
Quality & Review
Dual data review where specified; query documentation and resolution tracking; reconciliation sign-off; lock checklist completion. Specific quality requirements are agreed in the statement of work.
Client Responsibilities & Dependencies
Provision of protocol, CRF specifications, data conventions and coding dictionaries; timely query responses; approval of DMP and lock documentation; access to EDC system where applicable.
Biostatistics and Statistical Programming
Our biostatistics and statistical programming team supports clinical trials and observational studies with analysis planning, programming, output production and quality control, working to ICH E9 and applicable regulatory guidance.
Scope of Support
Statistical analysis plan (SAP) development; randomisation and sample size support; statistical programming in SAS or R; production of tables, listings and figures (TLFs); quality control of outputs; integrated summaries where agreed.
Typical Deliverables
Statistical Analysis Plan; randomisation schedule (where applicable); annotated shells; TLF package; QC documentation; analysis dataset specifications; final statistical report sections.
Project Workflow
Protocol and SAP review → shell development → programming → QC → output review with sponsor → final delivery.
Quality & Review
Programmer and independent QC review of all outputs; version control of programs and outputs; documented QC sign-off. Specific QC requirements are defined in the SAP and project procedures.
Client Responsibilities & Dependencies
Provision of protocol, SAP inputs and data conventions; timely review and approval of shells and SAP; access to analysis datasets; sign-off on final outputs.
CDISC and Regulatory Data Standards
IDDCR Global Research supports sponsors and CROs in developing CDISC-compliant submission datasets and documentation, including SDTM, ADaM, Define-XML and the Study Data Reviewer's Guide (SDRG), aligned with applicable FDA and EMA data standards guidance.
Scope of Support
SDTM mapping and dataset development; ADaM dataset development; Define-XML creation; SDRG authoring; Pinnacle 21 validation and issue resolution; submission-readiness review.
Typical Deliverables
SDTM datasets and mapping specifications; ADaM datasets and specifications; Define-XML; SDRG; Pinnacle 21 validation report; submission package.
Project Workflow
Standards review and mapping planning → SDTM development → ADaM development → Define-XML and SDRG → validation → sponsor review → submission package.
Quality & Review
Pinnacle 21 validation at each milestone; independent review of mapping specifications and datasets; documented issue resolution. Compliance with applicable CDISC implementation guides.
Client Responsibilities & Dependencies
Provision of raw datasets, data conventions, protocol and SAP; timely review of mapping specifications; approval of Define-XML and SDRG; confirmation of applicable CDISC versions and submission requirements.
Pharmacovigilance and Drug Safety
IDDCR Global Research provides pharmacovigilance support services for clinical trials and post-marketing activities, including safety case processing, narrative support and safety data reconciliation, within the scope agreed for each project.
Scope of Support
Individual Case Safety Report (ICSR) processing; MedDRA coding; case quality review; narrative writing support; safety data reconciliation; expedited reporting support (SUSAR/SAE); aggregate report support where agreed.
Typical Deliverables
Processed ICSRs; MedDRA-coded case data; case narratives; reconciliation reports; expedited report documentation; aggregate report sections (where in scope).
Project Workflow
Case receipt and triage → data entry and MedDRA coding → medical review → narrative preparation → quality review → submission or transfer.
Quality & Review
Case quality review against source documents; MedDRA coding review; narrative review for accuracy and completeness. Specific quality requirements are agreed in the project scope.
Client Responsibilities & Dependencies
Provision of source documents and case information; timely responses to queries; approval of narratives and case data; confirmation of applicable reporting timelines and regulatory requirements.
Clinical Research Support
IDDCR Global Research provides targeted clinical research support services to sponsors, CROs and academic institutions, including study documentation, regulatory submission support and clinical operations assistance, within the scope agreed for each engagement.
Scope of Support
Clinical study report (CSR) support; regulatory document preparation; protocol synopsis and amendment support; study start-up documentation; training material development; clinical operations support as agreed.
Typical Deliverables
CSR sections or full CSR (where in scope); regulatory submission documents; protocol documents; training materials; study start-up documentation.
Project Workflow
Requirements review → document planning → drafting → internal review → sponsor review and comment resolution → final delivery.
Quality & Review
Internal review of all documents prior to sponsor submission; version control and change tracking; documented approval. Specific quality requirements are agreed in the project scope.
Client Responsibilities & Dependencies
Provision of source data, protocols and study information; timely review and approval of documents; confirmation of applicable regulatory requirements and submission timelines.
How We Work
A Structured Approach to Project Delivery
The workflow below describes our general approach. Specific activities, timelines and quality requirements depend on the agreed project scope and procedures.
Initial Discussion
Understand the sponsor's objectives, study requirements, deliverables and timelines. Identify key dependencies and constraints.
Scope Definition
Agree the statement of work, responsibilities, assumptions, exclusions and acceptance criteria. Document agreed scope in writing.
Project Planning
Define milestones, resource requirements, communication channels, dependencies and escalation arrangements.
Execution
Perform the agreed activities according to applicable procedures, specifications and project requirements.
Review and Quality Checks
Conduct appropriate reviews and checks according to the service scope, project procedures and agreed quality requirements.
Delivery and Handover
Provide agreed deliverables, supporting documentation, issue summaries and handover information.
Sample Deliverables
Understand What Your Project Can Receive
The examples below illustrate the structure and content of typical project deliverables. All examples use synthetic data and are for capability demonstration only.
Clinical Data Management
Data Management Plan — Outline
Illustrative structure of a DMP covering study overview, data collection methods, data review procedures, query management, reconciliation and database lock activities.
- Study and database overview
- Data collection and entry procedures
- Data review and query management
- External data reconciliation
- Database lock checklist
CDISC Standards
SDTM Mapping Specification — Example
Illustrative SDTM mapping specification showing source variable to SDTM variable mapping, derivation rules and controlled terminology references for a synthetic study.
- Source-to-SDTM variable mapping
- Derivation rules and algorithms
- Controlled terminology references
- Supplemental qualifier definitions
- Mapping assumptions and exclusions
CDISC Standards
Define-XML and SDRG — Example Structure
Illustrative Define-XML and Study Data Reviewer's Guide structure for a synthetic submission package, demonstrating dataset and variable documentation.
- Dataset-level metadata
- Variable-level metadata and labels
- Controlled terminology references
- SDRG study overview section
- Data conformance notes
Biostatistics
Statistical Analysis Plan — Outline
Illustrative SAP outline covering study objectives, estimands, analysis populations, primary and secondary endpoints, and handling of missing data.
- Study objectives and estimands
- Analysis populations
- Primary and secondary endpoint analyses
- Handling of missing data
- Sensitivity and exploratory analyses
Statistical Programming
Programming QC Checklist — Example
Illustrative QC checklist used to document independent programmer review of TLF outputs against the SAP and annotated shells.
- Program header and version check
- Output vs SAP alignment
- Data source and population verification
- Statistical method verification
- Format and presentation review
Pharmacovigilance
Case-Processing Workflow — Illustrative
Illustrative ICSR processing workflow showing case receipt, triage, data entry, MedDRA coding, medical review, narrative preparation and quality review steps.
- Case receipt and triage
- Data entry and MedDRA coding
- Medical review and assessment
- Narrative preparation and review
- Quality check and case closure
Our Approach in Practice
Illustrative Project Scenario
Illustrative Scenario: Phase II Oncology Study — CDM and CDISC Support
Project Context
A hypothetical Phase II oncology clinical trial with approximately 150 subjects across multiple sites, requiring integrated CDM and CDISC submission support.
Client Challenge
The sponsor required a clearly scoped CDM and CDISC package with defined responsibilities, documented deliverables and structured communication to support a planned regulatory submission.
Scope of Work
Data management planning; eCRF review and annotation; data review and query management; database lock; SDTM and ADaM dataset development; Define-XML and SDRG; Pinnacle 21 validation.
Approach & Deliverables
DMP developed and approved prior to database go-live. Ongoing data review and query management throughout the study. SDTM mapping specifications agreed with sponsor prior to programming. ADaM datasets developed to agreed SAP. Define-XML and SDRG prepared for submission package.
Quality & Review Approach
Independent QC of SDTM and ADaM datasets against mapping specifications. Pinnacle 21 validation at each milestone with documented issue resolution. Database lock checklist completed and approved.
Outcome
Agreed deliverables provided within the project timeline. Submission package included SDTM and ADaM datasets, Define-XML, SDRG and Pinnacle 21 validation report. All deliverables reviewed and approved by sponsor prior to submission.
Quality & Data Integrity
Quality, Traceability and Responsible Delivery
Documented processes, data integrity, appropriate review and clear project responsibilities are central to how IDDCR Global Research approaches every project. We do not claim certifications or regulatory approvals beyond what has been verified.
Documented Processes
Project activities are performed according to agreed procedures, specifications and project-specific requirements documented in the statement of work.
Data Integrity
Data handling, review and transfer activities are designed to maintain accuracy, completeness and traceability throughout the project lifecycle.
Appropriate Review
Review and quality check activities are scoped to the project requirements and agreed in the statement of work, not applied uniformly across all services.
Clear Responsibilities
Sponsor and CRO responsibilities, assumptions, exclusions and acceptance criteria are agreed and documented before project execution begins.
Service FAQs
Frequently Asked Questions
Request a Proposal
Tell Us About Your Clinical Research Project
Complete the form below and we will review your requirements and be in touch to discuss the appropriate scope, deliverables and next steps. Fields marked with an asterisk are required.
Ready to Discuss Your Project?
Share your requirements and we will review them and be in touch to discuss scope, deliverables and next steps.