DATA MANAGEMENT PLAN REVIEW SERVICES
BioBoston CRO provides clinical trial Data Management Plan review services for sponsors that need an independent assessment of whether data-management responsibilities, systems, standards, data flow, cleaning, reconciliation, quality control, lock, transfer, security, and archival activities are adequately defined before or during study execution. Support can include development of a new plan, targeted review, vendor-plan assessment, amendment support, or remediation of an incomplete plan.
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.
The engagement should be scoped around the current state of the work, the intended decision or milestone, the source package, and the sponsor's approval responsibilities.
Independently assess whether the plan reflects the protocol, contracts, systems, data sources, responsibilities, standards, cleaning strategy, reconciliations, and lock requirements.
Develop or refine the Data Management Plan before EDC build, external-data integration, user acceptance testing, and study startup are too advanced.
Update the plan after protocol amendments, new vendors, new data sources, system changes, recurring queries, reconciliation gaps, or revised lock strategy.
when needed
Problems
The service is most valuable when the team can identify the specific control gap, decision, deliverable, or recovery need rather than requesting generic capacity.
Scope
The exact scope depends on the maturity of the work, the quality of the inputs, the sponsor’s procedures, the review model, and the target milestone.
Deliverables
Deliverables should be confirmed at kickoff and linked to defined sponsor decisions, review cycles, and downstream handoffs.
Client inputs
The sponsor does not need every detail finalized before kickoff, but approved decisions, open questions, source owners, reviewers, and deadlines must be distinguishable.
Process
1. Confirm the purpose, current state, intended use, milestone, stakeholders, responsibilities, systems or vendors, and agreed deliverables.
2. Review available source materials, prior decisions, procedures, evidence, and open issues; issue a focused gap and dependency list.
3. Develop the work plan, specifications, document, assessment, or control package included in scope.
4. Coordinate review through named sponsor and cross-functional decision owners and maintain a controlled open-item and comment process.
5. Perform the agreed technical, quality, consistency, or operational checks and document remaining risks or limitations.
6. Prepare the approved handoff, implementation, submission, remediation, archive, or next-step package as defined in scope.
Considerations
The work should remain proportionate to the risk and intended use, follow the sponsor’s controlled process, and preserve clear sponsor decision authority.
Engagement options
BioBoston leads the defined scope from assessment and planning through drafting or execution, review, quality control, and handoff.
BioBoston addresses a specific section, decision, backlog, finding, vendor issue, or stalled deliverable without expanding the engagement unnecessarily.
BioBoston provides an objective second-line review, oversight role, or embedded specialist while the sponsor or another vendor retains primary execution.
RELATED SERVICES
Configure the EDC and database structure according to approved protocol, eCRF, standards, data flow, and validation decisions.
Design or independently review the electronic case report forms that capture protocol-required data.
Assess vendor capabilities, quality system, validation, security, service model, controls, and fitness for intended use.
Align data definitions, analysis populations, derivations, timing, outputs, and database-lock needs with the Statistical Analysis Plan.
Expertise
Data Management Plan experience should match the study design, phase, data sources, endpoints, standards, systems, vendor model, external integrations, coding, reconciliation, lock, and regulatory use.
RESOURCES
Explore the following resources for additional insights and information relevant to this service.
A planned checklist for protocol alignment, roles, systems, standards, data flow, cleaning, coding, reconciliation, lock, transfer, security, and archive.
A planned tool for source, owner, system, format, transfer, validation, transformation, review, reconciliation, output, and final disposition.
A planned checklist for data entry, queries, coding, reconciliations, deviations, approvals, external data, quality control, freeze, lock, transfer, and archive.
FAQs
Review may cover protocol alignment, roles, systems, standards, eCRF and database interfaces, edit checks, queries, coding, external data, reconciliation, quality control, metrics, lock, transfer, security, archival, and sponsor oversight.
Yes, when the protocol, data sources, systems, vendors, responsibilities, standards, timelines, and key decisions are sufficiently defined. The plan may require controlled updates as the study evolves.
Yes. An independent sponsor-side review can assess whether the plan is study-specific, complete, feasible, internally consistent, aligned with contracts and other plans, and adequate for sponsor oversight.
No. The Data Management Plan defines the operating model and controls. EDC Build and Database Design is a separate execution service, though the two workstreams should be closely coordinated.
Updates may be needed after material protocol, vendor, system, data-source, standards, coding, reconciliation, safety, statistical, lock, transfer, security, or archival changes.
No. The plan establishes responsibilities and controls, but data quality depends on implementation, systems, source data, site conduct, review, issue management, and ongoing oversight.
PROJECT FORM
Share the study stage, protocol, current plan status, systems, vendors, data sources, known gaps, and target database milestone. 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, critical data, systems, vendors, responsibilities, standards, current plan, issues, and next database milestone. BioBoston can then define the development, review, amendment, or sponsor-oversight scope.
