Clinical Research Services
Clinical programs slow down when teams, systems, and information are disconnected.
Databean provides expertise across the study lifecycle - from protocol development through study execution, analysis, and reporting.
Study Design & Strategy
Start with the evidence you need.
Clinical and regulatory strategy, streamlined study design, protocol development, and evidence planning aligned with your research objectives and the questions your study is designed to answer.
Explore Study Design
Clinical Operations
Turn the protocol into an executable study.
Study start-up, site activation, project management, monitoring, vendor coordination, and operational oversight—integrated to keep your study aligned, efficient, and on track.
Explore Clinical Operations
Data & Safety
Connect the clinical picture.
EDC, data management, medical coding, safety, medical review, and clinical event adjudication unified through TrialPoint™ to improve data quality, visibility, and end-to-end traceability.
Explore Data & Safety
Quality & eTMF
Build readiness into the study.
Training, essential document management, quality processes, investigational product oversight, and inspection readiness integrated with ongoing study activities to maintain compliance, consistency, and operational control.
Explore Study Support
Study Intelligence
See what needs attention.
Bring enrollment, site performance, monitoring, data quality, safety, milestones, and risk together to provide a clear, real-time view of study performance and emerging priorities.
Explore Reporting & Analytics
Investigational Product
Know where every product is.
Databean manages investigational product and clinical supplies across the study lifecycle—from planning and distribution through accountability, reconciliation, and closeout.
Explore Investigational Product
01
Study Design
Design the evidence plan around the outcomes that matter.
Databean supports sponsors across the full evidence lifecycle—from early feasibility and first-in-human studies through pilot and pivotal trials, post-market studies, and real-world evidence programs.
Design studies around the evidence you need to generate—from clinical strategy and protocol development through endpoints, sample size, statistical planning, and operational design.
Databean capabilities include:
- Protocol development
- Endpoint selection
- Clinical development and evidence strategy
- Bayesian and frequentist study designs
- Sample-size determination
- Randomization and stratification
- Statistical analysis plans
- DSMB support
- Statistical programming
- Tables, listings, figures, and reports
- Technical and scientific writing
- Regulatory and scientific meeting support
Connected through TrialPoint™
Study requirements defined during design flow directly into TrialPoint™, translating the protocol into visits, data collection, workflows, randomization, monitoring, and reporting. This creates a clear, connected path from study design through execution.
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03
Clinical Operations
Turn the protocol into an executable study.
Effective study management goes beyond tasks and timelines. It brings sites, vendors, data, monitoring, documents, budgets, and decisions together around a clear clinical strategy—keeping every part of the study aligned and moving forward.
Databean capabilities include:
- Study start-up
- Site identification and selection
- Site activation
- IRB/EC coordination
- Investigator and site training
- Enrollment management
- Vendor and core laboratory coordination
- Budget and payments
- Timeline and milestone management
- Risk management
- Study closeout
TrialPoint™ connects execution to oversight.
Study teams gain a shared, real-time view of sites, subjects, milestones, monitoring, data, documents, issues, and risk—eliminating the need to piece together study status across multiple systems.
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04
Study Oversight
Focus oversight where it matters.
Effective monitoring protects participants, supports protocol compliance, and identifies risks to data quality before they become problems.
Databean designs monitoring strategies around the needs and risks of each study, combining onsite, remote, centralized, and risk-based approaches as appropriate.
Databean capabilities include:
- Monitoring strategy and planning
- Site initiation, interim, and closeout visits
- Remote and centralized monitoring
- Risk-based monitoring
- Source data review and verification
- Protocol compliance review
- Site performance management
- Corrective actions and follow-up
Connected through TrialPoint™
TrialPoint™ connects monitoring with real-time clinical and operational data, giving teams the visibility to identify trends, prioritize risk, and focus resources where they can have the greatest impact.
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06
Safety & Clinical Events
See every event in the context of the complete clinical picture.
Effective safety and clinical event management depends on structured review, consistent documentation, and end-to-end traceability throughout the study.
Databean supports:
- Safety data management
- Medical coding
- Clinical Events Committees
- Endpoint adjudication
- Event documentation
- Review and adjudication workflows
- Safety reconciliation
- Safety reports
Connected through TrialPoint™
TrialPoint™ brings the event, clinical data, supporting documentation, reviewers, decisions, and final determination together in a single, fully traceable workflow.
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08
Quality & Document Management
Build inspection readiness into study execution.
Essential documents, training, and quality records should be connected to the work they support—not managed separately from it.
Databean capabilities include:
- Trial master file management
- Investigator site file management
- Essential document collection and review
- Document quality control
- Study and system training
- Controlled documents
- Quality workflows
- CAPA support
- Inspection readiness
Connected through TrialPoint™
TrialPoint™ eTMF and eQMS & Learning connect training, documents, quality activities, sites, users, and study workflows—creating a complete, traceable record across the program.
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05
EDC & Data Management
Clinical data connected to the study behind it.
Databean manages clinical data across the study lifecycle—from CRF design and database build through data integration, review, reconciliation, and database lock.
Databean capabilities include:
- CRF and database design
- Data standards and dictionaries
- Edit checks and validation
- Medical and safety coding
- Query management
- Core lab data integration
- Imaging uploads
- Data reconciliation
- Database lock
- Data quality reporting
TrialPoint™ EDC integrates with the broader study environment.
TrialPoint™ connects clinical data with monitoring, safety, investigational product, documents, workflows, and reporting—giving teams real-time visibility into data quality, study performance, and emerging risk.
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09
Reporting & Study Intelligence
See what’s happening across your study—and what needs attention.
Clinical studies generate enormous amounts of data. The value comes from turning that data into insight teams can act on.
TrialPoint™ brings clinical and operational information together through configurable reports and dashboards.
Including:
- Enrollment and retention
- Site performance
- Monitoring
- Data quality
- Queries
- Safety
- Investigational product
- Documentation
- Training and quality
- Milestones and timelines
- Financial reports
- Study risk
A current view of performance
Instead of waiting for periodic reports assembled from separate systems, teams can work from a current view of study performance and identify where attention is needed.
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07
Investigational Product
Know where every product is—and where it’s been.
Databean manages investigational product and clinical supplies across the study lifecycle—from planning and distribution through accountability, reconciliation, and closeout.
Connected through TrialPoint™
TrialPoint™ manages product from shipment and receipt through inventory, assignment, dispensing, return, and reconciliation—maintaining a complete, traceable history connected to every site, subject, and study activity.
Product accountability becomes part of the study record—not a separate spreadsheet or standalone system that needs to be reconciled later.
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10
Post-Market & Real-World Evidence
Approval is a milestone. Keep building the evidence that comes next.
Databean supports:
- Post-market surveillance
- Registries
- Long-term follow-up studies
- Investigator-initiated studies
- Real-world evidence programs
- Product performance programs
Connected through TrialPoint™
TrialPoint™ extends the data, workflows, and processes established during clinical development into post-market research—maintaining continuity from development through real-world use.
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11
Trial Rescue
When a study gets off track, let the evidence show you where to start.
Missed timelines and rising costs are often symptoms. The real challenge is identifying—and addressing—the underlying causes.
Databean evaluates the study across protocol design, sites, enrollment, monitoring, data, vendors, technology, workflows, and governance to identify the root causes affecting performance.
Databean then builds a prioritized recovery plan, using TrialPoint™ where appropriate to bring study information together, strengthen workflows, and provide the visibility needed to get the study back on track.
Regain control of the study.
Study recovery isn’t simply about changing vendors or adding resources. It’s about identifying what isn’t working, addressing the root causes, and restoring control of the study.
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