CLINICAL DATA MANAGEMENT SERVICES
BioBoston CRO provides clinical data management services for sponsors that need a controlled approach to data collection, Electronic Data Capture planning, case-report-form design, data cleaning, reconciliation, database lock, and data handoff. Support can address one defined deliverable, an independent review, sponsor-side oversight, temporary capacity, or a broader data-management workstream.
Global Reach
Therapeutic Area Coverage
Years of Experience
START A CONVERSATION
Select the support you need and share a few details about your project. We’ll use this information to route your inquiry to the appropriate BioBoston team member.
Please do not submit confidential, patient-identifiable, or proprietary information through this form.
SERVICES
Develop or independently review the plan for data flow, roles, systems, edit checks, queries, coding, reconciliation, quality review, database lock, archival, and security.
Use when the plan must become study-specific, reviewable, and aligned with actual vendors and systems.
Assess an Electronic Data Capture vendor's functionality, quality system, validation evidence, security, change control, service model, support, and fit for the intended study.
Use before selection, during due diligence, after a major change, or when sponsor confidence in the vendor is incomplete.
Plan, configure, review, or oversee the Electronic Data Capture database structure, visits, forms, fields, rules, roles, testing, and release activities based on approved specifications.
Use when the study needs a controlled bridge from protocol and case-report-form design to a tested production database.
Design or independently review electronic case report forms and fields for protocol alignment, usability, data quality, analysis needs, safety, standards, and site burden.
Use before or during database build, after a major protocol change, or when forms are producing avoidable data problems.
Define or review edit-check logic, severity, timing, dependencies, false-positive risk, user workflow, testing, and change control without creating a separate Tier 2 page.
Review query generation, aging, trends, site burden, escalation, closure, metrics, and vendor performance from the sponsor perspective.
Plan or oversee reconciliation of safety, laboratory, imaging, device, randomization, supply, central-reading, and other external or parallel data sources.
Assess outstanding queries, coding, reconciliations, data changes, approvals, documentation, vendor tasks, and decision criteria before lock.
Clarify access, transfer, retention, archive format, vendor exit, security responsibilities, and documentation for the defined study environment.
Common Triggers
Desired outcomes
Collect the data needed for protocol objectives, endpoint analysis, safety oversight, operations, and reporting without unnecessary burden.
Connect protocol requirements to forms, fields, database structure, edit checks, external data, coding, and analysis specifications.
Make vendor responsibilities, decisions, metrics, issues, changes, and lock criteria reviewable by the sponsor.
Identify unresolved data, system, reconciliation, documentation, and approval dependencies before the planned lock date.
RELATED SERVICES
Align endpoints, analysis populations, derived variables, data standards, shells, and database-lock requirements with the planned analyses.
Ensure the complete protocol communicates the data-collection and assessment requirements needed for consistent database and form design.
Assess quality plans, vendor controls, audit readiness, CAPA, Trial Master File records, and sponsor oversight related to data management.
Manage Electronic Data Capture and data-management vendor performance, metrics, meetings, delivery, issues, and escalation.
Coordinate final data, tables, listings, figures, analysis interpretation, and report-source readiness.
deliverables
Approach
BioBoston begins with the protocol, analysis needs, data sources, Electronic Data Capture environment, vendors, procedures, timelines, quality risks, and sponsor decision rights. The work package is then defined around a specific data deliverable or oversight objective.
The sponsor remains responsible for data-management decisions, vendor oversight, database approval, and regulatory representations. BioBoston can provide strategy, design, review, execution support, independent assessment, or sponsor-side oversight through the sponsor’s approved systems and processes.
Process
1. Confirm the study stage, protocol and analysis maturity, data sources, vendors, systems, responsibilities, milestones, and requested data-management role.
2. Review the protocol, schedule of activities, Statistical Analysis Plan, existing forms and plans, data flows, vendor documentation, procedures, and known issues.
3. Develop or assess the plan, vendor qualification, electronic case report forms, database design, edit checks, reconciliation, oversight, or lock-readiness package included in scope.
4. Coordinate clinical, biostatistics, safety, medical, operations, quality, technology, and vendor review through named decision owners.
5. Perform the agreed functional and quality checks, resolve comments, document changes, and identify remaining risks or dependencies.
6. Support approval, testing, release, cleaning, lock, transfer, archive, or transition activities as defined in the engagement.
Data management is most effective when the protocol, analysis needs, data sources, systems, vendors, quality controls, and database-lock decisions are designed as one connected process.
Define the data-management approach, Electronic Data Capture requirements, electronic case report forms, edit-check strategy, data flows, and responsibilities before build begins.
Independently assess plans, specifications, build decisions, query performance, reconciliation, quality metrics, and lock readiness.
Stabilize open queries, reconciliations, coding, external data, missing decisions, database changes, and lock-readiness evidence.
Expertise
Data-management experience should match the study design, data sources, Electronic Data Capture environment, standards, vendor model, analysis needs, and milestone. Do not publish specific platform capability until it has been confirmed and approved for the page.
RESOURCES
A planned checklist for data flow, roles, systems, edit checks, queries, reconciliation, coding, lock, archival, and security.
A planned buyer guide covering functionality, validation evidence, security, support, change control, service model, and vendor exit.
A planned checklist for queries, coding, reconciliations, external data, changes, approvals, documentation, and final decision ownership.
FAQs
The approved CRO structure includes broad clinical data management plus focused services for Data Management Plan Review, Electronic Data Capture Vendor Qualification, EDC Build and Database Design, and electronic case report form Design and Review. The Tier 1 page also covers edit checks, query oversight, reconciliation, database-lock readiness, and data archival and security.
eCRF Design and Review owns the form structure, fields, usability, and data-collection content. EDC Build and Database Design owns configuration of the Electronic Data Capture system and database structure using approved forms and specifications.
Yes. Sponsor-side review or oversight can assess specifications, forms, build decisions, testing evidence, changes, metrics, issues, data cleaning, and lock readiness without duplicating the vendor’s execution.
Yes. A qualification can review functionality, quality and validation evidence, security, change control, support, service model, incident handling, business continuity, and study fit. The sponsor remains responsible for selection and approval.
Readiness should be reviewed early enough to resolve queries, coding, reconciliations, external data, database changes, documentation, vendor dependencies, and approval issues before the planned lock date.
Useful inputs include the protocol and schedule of activities, analysis plan, data sources, current forms and database specifications, vendors and systems, procedures, metrics, issue logs, target milestone, and the role BioBoston is expected to perform.
PROJECT FORM
Share the study stage, protocol and database status, vendors and systems involved, target data milestone, and the type of support you need. A BioBoston team member will review the request and follow up regarding fit and possible next steps.
Please do not submit confidential, patient-identifiable, or proprietary information through this form.
A productive first discussion identifies the protocol and analysis stage, data sources, systems, vendors, current documents, known issues, and next milestone. BioBoston can then define the appropriate design, review, qualification, oversight, or readiness scope.
