EDC BUILD AND DATABASE DESIGN SERVICES
BioBoston CRO provides EDC database build services and clinical database design support for sponsors that need a study-specific Electronic Data Capture environment configured from approved protocol, eCRF, standards, data-flow, user, security, integration, testing, and release requirements. Support can include build specifications, database configuration, edit checks, roles, integrations, user acceptance testing, validation documentation, change control, or independent build review.
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.
Connect protocol requirements, eCRFs, data standards, edit checks, coding, integrations, roles, reports, exports, testing, and release controls.
Assess configuration against approved requirements, forms, data flow, validation evidence, defects, user acceptance testing, and production-readiness criteria.
Identify requirement, design, configuration, integration, testing, defect, ownership, and schedule causes before resetting the release plan.
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
Define the form structure, fields, response options, instructions, annotations, and usability before configuration.
Establish the study data-management operating model, responsibilities, standards, cleaning, reconciliation, lock, and archive requirements.
Confirm vendor and platform suitability, validation evidence, security, service, and sponsor reliance before build.
Align data structure, derivations, analysis variables, timing, and exports with the Statistical Analysis Plan and reporting needs.
Expertise
EDC-build experience should match the selected platform, study design, protocol complexity, data standards, edit-check and coding model, integrations, validation approach, regions, and release timeline.
RESOURCES
Explore the following resources for additional insights and information relevant to this service.
A planned checklist for protocol, eCRFs, requirements, standards, roles, integrations, edit checks, testing, access, release, and change control.
A planned set of risk-based scenarios for forms, visits, roles, edit checks, queries, calculations, workflows, integrations, reports, exports, and defects.
A planned tool for requirements, forms, fields, visits, checks, integrations, reports, test cases, data migration, training, and release.
FAQs
Scope may include requirements, design, configuration, forms and fields, visit structure, codelists, roles, workflows, edit checks, reports, exports, integrations, testing, defects, traceability, release, and controlled changes.
Specific platform capability must be confirmed before scope. The assigned resource should have relevant system experience, and access, licenses, vendor controls, and environment responsibilities must be defined.
The workstreams are connected but have separate intent. eCRF Design defines what should be captured
and how the form should work; EDC Build configures and tests that approved design in the selected
system.
Yes. Independent review can assess requirements, design, configuration, traceability, testing, defects,
access, integrations, release evidence, and alignment with protocol and eCRFs.
Yes. Support may include UAT strategy, scenarios, scripts, test data, execution or review, defect triage, retesting, regression, evidence, and release recommendations.
No. Validation provides evidence that the configured database performs as intended within scope. Data quality also depends on source data, site conduct, users, external systems, review, queries, and ongoing controls.
PROJECT FORM
Share the study, selected EDC, protocol and eCRF status, integrations, current build stage, validation model, target release date, and principal risks. 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, forms, standards, platform, integrations, current build, defects, validation expectations, owners, and target release. BioBoston can then define the build, review, UAT, validation, or rescue scope.
