Keep your clinical trial data clean, inspection-ready, and submission-ready
BioBoston provides end-to-end clinical data management so your data is accurate, traceable, and compliant with GCP and global expectations supporting reliable analysis and smooth regulatory submissions.
- GCP-aligned data integrity and compliance
- EDC/CDMS setup, cleaning, and data lock support
- Supports early-phase through multicenter studies
- Timely, reliable reporting for key milestones
Who this is for
This service is a fit if
- You need to stand up or stabilize clinical data operations quickly
- Your study is falling behind due to data issues, queries, or inconsistent entry
- You want stronger data integrity and inspection readiness (GCP/ICH)
- You need experienced support for EDC build, database management, and cleaning
- You’re approaching interim analysis, database lock, CSR, or submission deadlines
What you’ll get
- You will receive a practical CDM package that supports clean execution:
- A Data Management Plan (DMP) aligned to your protocol and study needs
- EDC/CDMS setup and governance to reduce errors and rework
- Clean, validated datasets with documented quality checks
- Ongoing data cleaning and query management to keep sites on track
- SAE reconciliation support to strengthen safety reporting consistency
- Data lock support and final deliverables ready for stats/CSR/submission workflows
- Clear status reporting so timelines and risks are visible early
What we do
Our Clinical Data Management support can include:
- Data Management Plan (DMP) development
- EDC (Electronic Data Capture) system setup and configuration
- Database design, setup, and administration
- Edit checks, query management, and data cleaning
- Data verification and quality control procedures
- SAE reconciliation with safety databases
- Ongoing data monitoring and quality oversight
- Database lock planning and execution support
- Final data deliverables and report support for regulatory milestones
Why BioBoston
Clinical data issues create hidden delays and regulatory risk.
We bring experienced CDM professionals who focus on what matters most: consistency, traceability, and readiness for analysis and inspection. We scale to your study needs and keep the process controlled so your team isn’t surprised late in the trial.
Recent examples of how we help:
Supported a sponsor team by stabilizing EDC workflows, cleaning backlog data, and improving query turnaround so the trial stayed on schedule for a key milestone.
Helped a clinical program prepare for database lock by strengthening quality checks, SAE reconciliation, and documentation so datasets were analysis-ready and defensible.
Plan + setup
We align on deliverables (DMP, EDC build, cleaning cadence) and assign the right CDM lead.
Execute + control
We manage cleaning, reconciliation, and reporting through lock so your data stays reliable and ready.
Discovery call
We confirm your study design, systems, timelines, and current pain points.
How it works
Frequently Asked Questions
Yes. We scale support to your study size and complexity.
Yes. We can build, optimize, or take over ongoing management depending on your setup.
Yes. We support lock planning, final cleaning, documentation, and analysis-ready outputs.