Clinical Data Services,
End to End
From protocol development through first patient enrolled to regulatory submission, every service is designed to keep your data clean, compliant, and on schedule.
Full service or a la carte. Engage the entire team or just one capability. There is no all or nothing. Each department is available for full service, oversight only, or focused support to help complete a specific activity.
Clinical Data Management
Clariva's lead capability. From database design through database lock, every service is built to keep your data clean, compliant, and on schedule.
Clinical Database Design & Build
Architect and implement clinical databases using leading EDC platforms. We design CRFs, build edit checks, and configure your study database to handle complex protocol requirements with precision.
Wearables & Device Data Integration
Manage wearable sensor data and medical device data flows in clinical studies. We handle vendor data transfer agreements, ingestion into the clinical database, and ongoing review of device-sourced data.
CDISC Standards Implementation
Ensure regulatory compliance with expert SDTM and ADaM dataset creation. We map your data to CDISC standards and produce define.xml documentation for seamless submissions.
Data Cleaning & Query Management
Rigorous data review processes to ensure the highest data quality. From automated validation to manual review, we catch discrepancies before they become problems.
Submission-Ready Deliverables
End-to-end preparation of your clinical data packages for regulatory submission, including database lock procedures and transfer-ready datasets.
EDC System Administration
Expert management of your EDC environment including user access, study builds, and ongoing maintenance throughout the trial lifecycle.
Vendor & CRO Oversight
Act as your embedded data management lead to oversee CRO data operations, ensuring quality standards are met and timelines are maintained.
SOP & Process Development
Build or refine your Clinical Data Management SOPs and working practices to meet regulatory expectations and industry best practices.
Data Management Planning
Comprehensive data management plans tailored to your protocol, covering every aspect from data collection through database lock.
Biostatistics & Statistical Programming
For sponsors who need embedded statistical expertise from study design through regulatory submission.
Statistical Analysis Plan (SAP) Development
SAP development and finalization, plus sample size and endpoint contributions to the protocol.
Statistical Programming & TFL Production
CDISC (SDTM/ADaM) datasets, Tables/Figures/Listings produced per SAP specifications, plus randomization schedules.
Independent QC & Validation
Dual-programming validation approach. Validation programmers never serve as the production programmer on the same deliverable.
Regulatory Submission Support
NDA, BLA, and IND submission packages, interim and final analysis support, and database lock/unlock approval.
Medical Coding
Expert MedDRA and WHODrug coding from coding plan development through database lock.
Coding Plan Development
Establish coding conventions, auto-coding rules, and manual coding workflows before the first form goes live.
MedDRA & WHODrug Assignment
Accurate MedDRA and WHODrug assignment for adverse events, medications, and medical history terms.
Dictionary Version Management
Manage dictionary upgrades and recoding activities when new MedDRA or WHODrug versions release.
Coding Review & Reconciliation
Coding Review Reports for the Medical Monitor, cross-study consistency, and coding freeze reconciliation.
Medical Writing
Clear clinical documents prepared for submission, from protocol to publication.
Protocol & Amendment Authoring
Protocol development and amendments, structured for regulatory acceptance and operational clarity.
Clinical Study Reports (CSR)
CSR writing and finalization, integrating clinical, statistical, and data management results into a cohesive submission-ready report.
Investigator's Brochure (IB) Development
Investigator's Brochure creation and updates, keeping content current and regulatorily sound throughout the program.
Regulatory & Publication Documents
SAP narratives, ICF drafting, manuscripts, and regulatory submission narratives (IND, NDA, BLA), with QC and consistency review.
Clinical Study Coordinator Support
Remote Clinical Study Coordinator support for sponsors whose sites need extra capacity for timely data entry, query follow-up, and study documentation.
Site Query Handling & Safety Follow-Up
Timely query resolution and safety follow-up to keep sites on track and data current.
EDC Data Entry Support
Direct EDC data entry support for site staff, easing the burden on overstretched sites.
Investigator Site File Maintenance
Investigator Site File (ISF) management and compliance, keeping essential documents audit-ready.
Medical Record Abstraction
Source document management, medical record abstraction for eCRF entry, and data/image retrieval from outside facilities.