The TrialPoint™ ecosystem.
Turn your protocol into an operational framework.
TrialPoint™ is designed to support research across the clinical evidence lifecycle, from early development through post-market and real-world evidence generation. The platform can be configured around the requirements of each protocol, program, and organization—providing the structure needed for complex regulated trials while remaining flexible enough to support registries, investigator-initiated research, and multi-study research programs.
Start with the application you need today—or build a connected TrialPoint™ environment that grows with your program.
TrialPoint™
Integrated Clinical
Research Platform
People · Processes · Data Technology · Insights
TrialPoint™ Architect
Protocol, study design and configuration
Where your study takes shape.
Architect is where your study takes shape in TrialPoint™. Start with a proven protocol template or import your own protocol to establish the foundation for study configuration. Define the study structure, visits, assessments, data requirements, workflows, roles, and other protocol-driven requirements in one place.
From there, Architect translates the protocol into the applications and workflows needed to execute the study—helping maintain alignment between what the protocol requires and how the study operates. As requirements evolve, configurations can be updated without losing the connection between study design, data collection, and execution.
EDC
Clinical data connected to the rest of your study.
Clinical data connected to the rest of your study.
TrialPoint™ EDC turns your protocol into a structured environment for clinical data collection and management. Configure CRFs, edit checks, visit schedules, randomization, medical coding, imaging capture, and study-specific data workflows around the requirements of each protocol.
Built for flexibility, EDC supports simple and complex study designs without forcing every study into the same configuration. Data collection, validation, review, queries, and reconciliation remain connected throughout the study, giving teams a current view of data quality and completeness.
And because EDC is part of the broader TrialPoint™ environment, clinical data can inform monitoring, safety and clinical event review, investigational product management, study operations, and reporting—connecting the data you collect with the work and decisions it drives.
TrialPoint™ EDC includes:
- Configurable CRFs and visit schedules
- Real-time edit checks and validation
- Randomization and stratification
- Medical and safety coding
- Imaging and document capture
- Query management
- External and laboratory data
- Role-based access and blinding
- Visit-window calculations and alerts
- Data review and reporting
eTMF & Essential Documents
Documentation connected to study execution.
Documentation connected to study execution.
TrialPoint™ eTMF manages essential study documents within the same connected environment as the sites, people, milestones, and activities that generate them. Organize, collect, review, approve, and maintain documents throughout the study while preserving version history, audit trails, and document status.
Because the eTMF is connected to the broader TrialPoint™ environment, documents can be associated with the relevant study, site, user, activity, or milestone—providing context beyond the document itself. Teams can see what is complete, what is missing, what requires attention, and where documentation gaps may affect study readiness or compliance.
From study start-up through closeout, TrialPoint™ eTMF helps maintain a current, inspection-ready record of the study without treating document management as a separate activity that must be reconciled with study operations later.
eQMS & Learning
Connect quality to the work it governs.
Connect quality to the work it governs.
TrialPoint™ eQMS & Learning connects controlled documents, training, quality processes, and compliance records with the people and activities they govern. Manage policies, SOPs, work instructions, training requirements, quality events, CAPAs, and related records within a structured, traceable environment.
Controlled documents can be assigned to the appropriate roles and users, with training requirements triggered as documents are issued or revised. Teams can track acknowledgments, training completion, qualifications, document versions, effective dates, and other compliance requirements—helping ensure people are working from current procedures and have completed the training required for their responsibilities.
Quality activities can be managed through configurable workflows for deviations, nonconformances, CAPAs, change control, and other quality processes. Each activity can be connected to the relevant documentation, personnel, training, study, or operational process, creating a clear record from identification through investigation, action, and resolution.
By bringing quality management and learning into the broader TrialPoint™ environment, organizations gain greater visibility into compliance, training status, and quality trends—connecting the procedures that define how work should be performed with the people and activities responsible for carrying it out.
Study Management & Monitoring
Connect study operations with clinical insight.
Connect study operations with clinical insight.
TrialPoint™ Study Management brings the operational work of the study into one connected environment. Manage sites, subjects, milestones, monitoring, issues, tasks, study documentation, and day-to-day activities while maintaining a current view of progress across the program.
Because study management is connected to the broader TrialPoint™ environment, teams can see operational activity in the context of clinical data, enrollment, monitoring, safety, investigational product, documents, and other study information. Rather than assembling status reports from multiple systems, teams can identify delays, emerging risks, outstanding actions, and areas requiring attention as the study progresses.
From start-up through closeout, TrialPoint™ gives study teams a shared operational picture—helping sponsors, CROs, and research teams coordinate work, maintain accountability, and make informed decisions based on what is happening across the study.
TrialPoint™ gives project managers and clinical teams real-time visibility into:
- Site activation and performance
- Enrollment and retention
- Study milestones
- Monitoring activity
- Data completeness
- Safety and clinical event review
- Investigational product inventory
- Essential documents
- Open issues and risks
- Vendor and study team activities
- Trends, metrics and performance indicators
- Financial reports
ePRO / eCOA
Keep participants connected. Keep their experience part of the study.
Keep participants connected. Keep their experience part of the study.
TrialPoint™ ePRO enables participants to provide patient-reported outcomes, quality-of-life assessments, diaries, questionnaires, symptom information, and other study data remotely through structured, protocol-defined workflows.
Configure instruments, assessment schedules, reminders, completion windows, and study-specific questionnaires around the requirements of the protocol. Participants can complete required assessments outside the clinic, while study teams can monitor completion, identify missing or overdue assessments, and follow participant-reported information throughout the study.
Because ePRO is part of the broader TrialPoint™ environment, participant-reported data can remain connected to visits, clinical assessments, safety events, endpoints, and other study data. This gives research teams a more complete view of the participant experience without creating another disconnected source of information to reconcile later.
From symptom tracking and daily diaries to validated PRO instruments and quality-of-life assessments, TrialPoint™ ePRO helps capture the participant perspective as an integrated part of the clinical record.
Safety & Clinical Events
From event identification through final review.
From event identification through final review.
TrialPoint™ brings safety and clinical event management together with the clinical data and supporting documentation needed for informed review. Capture events, supporting records, assessments, follow-up information, and reviewer decisions within a structured, traceable workflow.
Because safety and event review are connected to the broader TrialPoint™ environment, reviewers can evaluate an event in the context of relevant subject data, visits, procedures, medications, imaging, laboratory results, and other supporting information. This provides a more complete clinical picture without requiring teams to assemble information from multiple systems.
Configure workflows for safety review, Clinical Events Committee (CEC) review, endpoint adjudication, and other study-specific processes—including reviewer assignments, independent assessments, queries, consensus or adjudication, and final determinations. Every step remains documented and traceable from the initial event through final resolution.
TrialPoint™ supports:
- Adverse event (AE) and serious adverse event (SAE) capture and management
- Adverse device effect (ADE) and serious adverse device effect (SADE) tracking
- Event identification and escalation
- Structured safety assessments and medical review
- Clinical Events Committee (CEC) review and endpoint adjudication
- Independent, blinded, and multi-reviewer workflows
- Supporting clinical data, imaging, and document review
- Coding and event classification
- Protocol-defined endpoint review
- Complete event and decision audit trails
- Safety listings, dashboards, metrics, and reporting
- Integration of safety activity with subject, site, and study-level data
By connecting the event, underlying clinical data, supporting evidence, reviewers, and final determination, TrialPoint™ creates a complete and traceable record of the safety and clinical event review process.
Investigational Product Accountability
Know where every product is—and where it’s been.
Know where every product is—and where it’s been.
Manage investigational drugs, devices, and clinical supplies from shipment and receipt through assignment, dispensing, return, and final reconciliation—maintaining complete accountability throughout the study.
TrialPoint™ supports:
- Investigational drugs, devices, and clinical supplies
- Product shipment, receipt, and confirmation
- Site and depot inventory management
- Lot, batch, serial number, and expiration tracking
- Kit and device-level accountability
- Subject assignment and product allocation
- Randomization-linked product assignment
- Dispensing and administration tracking
- Product returns, recovery, and disposition
- Inventory adjustments and reconciliation
- Resupply thresholds and inventory status monitoring
- Site-to-site and depot-to-site transfers
- Device replacement and exchange tracking
- Role-based access and permissions
- Complete product history and audit trail
- Site, subject, and study-level accountability reporting
- Final reconciliation and closeout
Because IP management is connected to the broader TrialPoint™ environment, product activity can remain linked to the appropriate subject, site, visit, procedure, randomization assignment, and clinical data—creating a traceable record from initial shipment through final disposition.
Core Lab Integration
Imaging, clinical review, and endpoint data—connected in one system.
Imaging, clinical review, and endpoint data—connected in one system.
Imaging and associated reports can be captured and managed directly within TrialPoint™ EDC, keeping them connected to the subject, visit, procedure, and clinical data they support. Teams can upload images and reports, track required submissions, manage review status, and maintain a complete audit trail without relying on separate repositories or disconnected workflows.
By keeping imaging within the EDC environment, clinical data, images, interpretations, and related documentation remain part of the same study record. This gives investigators, reviewers, and study teams a more complete clinical picture while reducing manual reconciliation and the movement of information between systems.
For studies requiring independent or centralized review, imaging workflows can also support assignment to reviewers, structured assessments, adjudication, and final determinations—maintaining traceability from the original image through the completed review.
