Clinical Data Management Support
Assisting research teams with data entry verification, electronic CRF tracking, validation checks, and query reconciliation.
What This Service Involves
Clinical research conclusions depend upon reliable, verifiable, and pristine data. ResearchPath supports research teams with structured clinical data management workflows, data discrepancy tracking, and rigorous quality checks to safeguard data integrity from collection through database lock.
Who It Is Intended For
Scope of Support
Our team provides disciplined coordination across the following agreed operational parameters:
- Electronic Case Report Form (eCRF) completion tracking and backlog clearing
- Manual and programmatic data discrepancy generation and resolution tracking
- Source Data Verification (SDV) preparation support for clinical monitors
- Data entry quality audits and error-rate trend analysis
- Assistance with medical coding support tracking (MedDRA, WHO-DD conventions)
- Pre-database lock checklist execution and data completeness verification
Operational Workflow Stages
Data Management Plan Review
Review the protocol data management plan (DMP), edit checks, and validation rules.
Ongoing Data Entry Support
Facilitate timely transcription of source documents into the validated EDC system.
Discrepancy & Query Management
Identify data discrepancies, generate precise queries, and coordinate site clarification.
Data Cleaning & Lock Readiness
Perform final data reconciliations, resolve outstanding queries, and prepare for formal lock.
Expected Deliverables
- Strict adherence to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate)
- Traceable electronic audit trails for all data entry and correction activities
- Protection of personal health information through strict de-identification standards
- No modification of site clinical data without verified investigator sign-off
Note: ResearchPath provides coordination and operational support. We do not provide guarantees regarding regulatory approval decisions, trial clinical efficacy, or patient recruitment targets.
Frequently Asked Questions
Which Electronic Data Capture (EDC) systems do you work with?
Our team is trained on industry-standard EDC platforms including Medidata Rave, Oracle InForm, REDCap, and regional web-based trial portals.
Do you provide blind data review services?
We assist teams with the operational preparation of data listings and discrepancy trackers required for blinded review sessions prior to study unblinding.
Discuss Your Clinical Requirements
Provide your study parameters or operational needs below. Our clinical operations team will review your specifications and contact you directly.
Important Notice: This portal is dedicated strictly to organizational, sponsor, and investigator inquiries. Please do not submit patient-identifying health information (PHI) or personal medical records through this form.
Operational Office
406, B Wing, City Vista, Kharadi, Pune, Maharashtra, India.
Phone: +91 91464 52014
Email: info@researchpath.in