Clinical Data Designed for Regulatory Evidence
Bioexcel supports medical device and IVD studies with eCRF design, EDC configuration, data validation, query management, data cleaning, reconciliation and database lock.
Our data-management approach connects the protocol, endpoints, clinical operations and statistical requirements so that the final dataset is usable for the study's intended clinical and regulatory evidence objective.
Does Bioexcel Provide Clinical Data Management for Medical Device Studies?
Yes. Bioexcel provides clinical data management for medical device and IVD studies, including Data Management Plans, eCRF design, EDC setup, query management, data cleaning, reconciliation, database lock and transfer of finalized datasets for statistical analysis.
Bioexcel Lifesciences & Research LLP provides specialized clinical data management and EDC support for medical device and IVD studies, including eCRF design, database configuration, query management, data cleaning, reconciliation, database lock and statistical data transfer.
The Database Should Be Designed From the Protocol
A strong clinical database should reflect:
- Study objectives
- Primary endpoints
- Secondary endpoints
- Safety endpoints
- Visit schedule
- Eligibility
- Device procedures
- Device deficiencies
- Laboratory data
- Imaging
- Follow-up
- Protocol deviations
- Statistical analysis requirements
If these elements are not translated correctly into the database, problems may only become visible after recruitment begins.
From Protocol to Analysis-Ready Dataset
Protocol Review
- Objectives
- Endpoints
- Visits
- Eligibility
- Safety variables
- Device variables
- Laboratory variables
- Follow-up
Output: Data Requirements Specification
Data Management Plan
- Data flow
- Responsibilities
- Query process
- Coding
- Reconciliation
- Cleaning
- Database lock
- Transfer
Output: Data Management Plan
CRF / eCRF Design
- Translate protocol requirements into structured fields
Output: CRF / eCRF Specification
Database Build
- Forms
- Visits
- User roles
- Edit checks
- Conditional logic
- Workflow
Output: Configured EDC
Validation & UAT
- Fields
- Logic
- Calculations
- Permissions
- Queries
- Exports
Output: Approved Study Database
Live Data Capture
- Screening
- Baseline
- Procedure
- Follow-up
- Safety
- Device data
- Lab data
Output: Live Dataset
Data Review
- Missing values
- Inconsistencies
- Outliers
- Endpoint issues
- Deviations
Output: Data Queries
Reconciliation
- Safety
- Laboratory
- Device accountability
- External data
Output: Consistent Final Data
Database Lock
- Query closure
- Final QC
- Required sign-offs
- Lock checklist
Output: Locked Database
Statistical Transfer
- Final exports
- Analysis datasets
- Metadata
- Transfer package
Output: Analysis-Ready Dataset
What Clinical Data Management Services Does Bioexcel Provide?
Bioexcel provides protocol review, Data Management Plans, eCRF design, EDC configuration, edit checks, query management, coding support, external data reconciliation, data cleaning, database lock and statistical data transfer for medical device and IVD studies.
What clinical data services does Bioexcel provide?
Bioexcel provides eCRF design, EDC configuration, data-management planning, query management, reconciliation, data cleaning, database lock and statistical data transfer for medical device and IVD studies.
Can Bioexcel provide standalone EDC/data support?
Yes. Sponsors can use Bioexcel for EDC or data management independently of full-service clinical operations.
What study types can Bioexcel support?
Bioexcel supports data management for medical device clinical investigations, PMCF, retrospective studies and IVD clinical performance programs.
Define the Data Process Before Study Go-Live
A Data Management Plan may include:
- Study overview
- Roles and responsibilities
- Data flow
- CRF/eCRF process
- EDC system
- Data-entry rules
- Data review
- Edit checks
- Query management
- Coding
- External data
- Safety reconciliation
- Protocol deviation handling
- Data cleaning
- Database freeze
- Database lock
- Data export
- Archiving
Can Bioexcel Prepare a Data Management Plan?
Yes. Bioexcel can develop a study-specific Data Management Plan defining how clinical data will be collected, reviewed, queried, reconciled, cleaned, finalized and transferred for analysis.
Medical Device eCRFs Need Device-Specific Data Fields
Potential forms:
Screening
- Participant ID
- Demographics
- Medical history
- Eligibility
- Consent
Procedure
- Device name/model
- Size
- Lot/batch
- Serial number
- Implant details
- Procedure duration
- Technical success
- Procedural success
Follow-Up
- Clinical status
- Device performance
- Imaging
- Functional outcomes
- Reintervention
Safety
- Adverse events
- Serious adverse events
- Device relationship
- Procedure relationship
- Device deficiencies
Protocol Deviations
- Type
- Date
- Reason
- Impact
- Corrective action
Can Bioexcel Design eCRFs for Medical Device Studies?
Yes. Bioexcel designs medical device eCRFs around protocol-defined endpoints, device procedures, safety events, device deficiencies, follow-up assessments and statistical requirements.
Data Structures for IVD Clinical Performance Studies
Potential fields:
- Participant ID
- Specimen ID
- Sample type
- Collection date/time
- Storage conditions
- Freeze-thaw history
- Sample volume
- Reference method
- Reference result
- Index-device result
- Lot number
- Operator
- Reader output
- Invalid result
- Repeat testing
- Discordant testing
- Clinical diagnosis
Can Bioexcel Manage IVD Clinical Performance Data?
Yes. Bioexcel can manage IVD datasets covering specimen traceability, reference testing, index-device results, invalid or repeated tests, discordant testing, clinical metadata and final performance-analysis datasets.
Electronic Data Capture for MedTech Studies
Potential EDC functionality:
- Role-based access
- Investigator entry
- Site-user access
- CRA access
- Sponsor access
- Audit trail
- Data validation
- Query management
- Visit tracking
- Data exports
- Study dashboards
- User administration
Optional Connected Functions
Can Bioexcel Provide EDC Without Managing the Full Clinical Study?
Yes. Bioexcel can provide EDC and clinical data-management services as standalone functional support when the sponsor or another CRO manages the clinical operations.
Convert the Protocol Into a Working Study Database
The database build should define:
- Visit structure
- Forms
- Field types
- Required fields
- Calculated fields
- Conditional logic
- Visit windows
- Edit checks
- User roles
- Query workflow
- Export structure
Test the Database Before First Patient In
Potential validation activities:
- Field verification
- Visit workflow testing
- Edit-check testing
- Conditional logic testing
- Calculation testing
- User-role testing
- Query testing
- Data-export testing
- Audit-trail testing
Detect Data Problems Early
Potential automated checks:
- Missing required values
- Invalid dates
- Visit sequence conflicts
- Eligibility conflicts
- Impossible age ranges
- Out-of-range laboratory values
- Device ID mismatch
- Duplicate specimen IDs
- Follow-up-window issues
Edit Check Types
Queries Should Improve Data Quality Without Overloading Sites
Potential Query Categories
- Missing data
- Inconsistent data
- Safety clarification
- Eligibility issue
- Endpoint clarification
- Device detail
- Protocol deviation
Does Bioexcel Manage Clinical Data Queries?
Yes. Bioexcel supports automated and manual query management, including query generation, site response review, aging oversight and closure of clinically relevant data discrepancies.
Continuous Review During Study Conduct
Bioexcel can monitor:
- Enrollment data
- Missing forms
- Data completion
- Query aging
- Follow-up completion
- Safety data
- Device deficiencies
- Protocol deviations
- Primary endpoint completeness
Suggested Dashboard KPIs
Standardized Coding Where Appropriate
Depending on study scope and sponsor requirements:
- Medical history
- Adverse events
- Concomitant medications
- Clinical conditions
- Procedures
Align EDC With Safety Records
Potential reconciliation:
- Participant
- Event
- Onset date
- Seriousness
- Severity
- Relatedness
- Outcome
- Report status
Data Sources
Laboratory, Imaging & Device Data
External data may include:
- Central laboratory
- Local laboratory
- Imaging core lab
- Reference laboratory
- Device-reader data
- Surgical system outputs
- Diagnostic analyzer data
- Wearable/device logs
Bioexcel Can Support
- Transfer specifications
- File structure
- Participant/sample matching
- Data validation
- Reconciliation
- Integration
Trace Every Specimen From Collection to Analysis
Potential Fields
- Specimen ID
- Participant ID
- Sample type
- Collection date
- Storage temperature
- Shipping
- Receipt
- Aliquot
- Reference result
- Index result
- Test lot
- Operator
Site Monitoring and Data Review Should Work Together
Shared Focus Areas
- Eligibility
- Consent
- Safety
- Device accountability
- Protocol deviations
- Primary endpoints
Turning Historical Hospital Records Into Standardized Data
Challenges May Include
- Missing variables
- Different terminology
- Variable follow-up
- Non-standard historical documentation
Can Bioexcel Manage Data for Retrospective PMCF?
Yes. Bioexcel can develop data-abstraction forms, eCRFs, validation rules, query processes and analysis-ready datasets for retrospective PMCF studies using historical clinical records.
Structured Data for Post-Market Evidence
PMCF databases may need to capture:
- Prospective patient follow-up
- Historical data
- Registry information
- Patient-reported outcomes
- Long-term device outcomes
- Safety
- Revision
- Reintervention
Clinical Data Management for European Programs
European programs may require consideration of:
- GDPR
- Data minimization
- Pseudonymization
- Role-based access
- Data-controller / processor roles
- Cross-border data flows
- Security
- Retention
- Contractual requirements
Can Bioexcel Manage Data for European Medical Device Studies?
Yes, subject to the applicable privacy, contractual, security and regulatory requirements governing the specific study data flow.
Central Data Management for India Clinical Studies
Bioexcel can support centralized data management for India-based:
- Clinical investigations
- PMCF
- Retrospective studies
- IVD performance studies
Prepare the Database Before Lock
Potential final checks:
- Forms complete
- Required fields complete
- Queries resolved
- Coding completed
- Safety reconciled
- External data reconciled
- Protocol deviations reviewed
- Critical endpoints verified
- Investigator sign-off completed where required
Controlled Finalization of the Clinical Database
A lock process may include:
- Recruitment/follow-up completion
- Final data entry
- Query closure
- Safety reconciliation
- External data completion
- Coding completion
- Final QC
- Required approvals
- Database lock
- Archive/export
Outputs
Can Bioexcel Perform Database Lock?
Yes. Bioexcel can manage the database-lock process after completion of required data entry, query resolution, reconciliation, final quality review and study-specific sign-offs.
Build the Database With the Final Analysis in Mind
ALCOA+ Principles
Clinical data should be:
Use this as a visual data-integrity framework.
Traceability of Data Changes
Appropriate electronic systems should preserve traceability of changes such as:
- Original value
- Updated value
- User
- Date/time
- Reason for change
This helps support data integrity and inspection readiness.
The Right User Should See the Right Data
Potential roles:
- Investigator
- Coordinator
- Monitor / CRA
- Data manager
- Medical reviewer
- Statistician
- Sponsor
- Project manager
- Administrator
Controls
- Unique user accounts
- Defined permissions
- Access review
- Access revocation
- Audit trail
Electronic Records and Controlled Systems
Where applicable to the study and intended use, relevant controls may include:
- User authentication
- Audit trail
- System validation
- Controlled access
- Record retention
- Electronic signatures where implemented
- Data security
Medical Device Data Under ISO 14155
Medical device data-management workflows should support:
- Data integrity
- Source traceability
- Safety data
- Device deficiencies
- Protocol deviations
- Monitoring
- Accurate clinical reporting
Measure Data Quality During the Study
Recommended KPIs:
- CRF completion rate
- Missing-data rate
- Query rate
- Query aging
- Average query-response time
- Missing visits
- Primary endpoint completion
- Safety reconciliation status
- Protocol deviation rate
- Site-level data quality
Use these metrics for operational oversight.
Study Visibility Without Reviewing Every CRF
Recruitment
- Screened
- Enrolled
- Completed
Data
- Completion %
- Missing forms
- Open queries
- Query aging
Study Quality
- Protocol deviations
- Missing visits
- Safety status
Database
- Cleaning status
- Lock readiness
Full-Service or Functional Data Management
Full-Service Study
Clinical operations + data + statistics.
Data Management Only
Sponsor/CRO manages the study; Bioexcel manages the database and data.
EDC Only
Database design, configuration and support.
Data + Statistics
Bioexcel manages database cleaning through final statistical analysis.
Rescue Data Management
Bioexcel reviews an ongoing study experiencing:
- Excessive queries
- Missing data
- Database design problems
- Delayed cleaning
- Lock-readiness issues
Can Bioexcel Take Over Data Management for an Ongoing Study?
Potentially yes. Bioexcel can assess an ongoing study database, identify data-quality and workflow issues and develop a rescue plan for query management, data cleaning, reconciliation and database lock.
Why MedTech Sponsors Use Bioexcel for Clinical Data Management
Medical Device & IVD Focus
Data structures accommodate device procedures, deficiencies, implants, specimens and diagnostic testing.
Protocol-to-Database Design
The database is developed from the evidence and endpoint strategy.
Monitoring Integration
Clinical monitoring and data management operate as connected functions.
Statistics Integration
The final analysis is considered before database build.
Regulatory Orientation
Data are structured for CIR, CPSR, PMCF, CER and related evidence outputs.
Flexible Scope
Full-service or standalone functional support.
Clinical Data Management Deliverables
Depending on scope:
- Data Management Plan
- CRF
- eCRF
- CRF completion guidelines
- Database specification
- Edit-check specification
- EDC build
- UAT documentation
- Role-access matrix
- Data Review Plan
- Query-management process
- Coding plan where applicable
- External-data specifications
- Reconciliation documentation
- Data-cleaning records
- Database Lock Checklist
- Final data exports
- Analysis datasets
- Archive package
Clinical Data in Practice
Medical Device Prospective Study
Need: Multi-visit device study
Bioexcel Role: Bioexcel Role: eCRF, EDC, queries, database lock, statistics
Retrospective PMCF
Need: Convert hospital records into analyzable data
Bioexcel Role: Bioexcel Role: Abstraction form, EDC, source review, cleaning, analysis dataset
IVD Clinical Performance
Need: Match reference and index-test results
Bioexcel Role: Bioexcel Role: Specimen database, validation, discordant-result tracking and statistical transfer
Frequently Asked Questions About Clinical Data Management
Clinical data management is the structured process of designing, collecting, reviewing, validating, cleaning and finalizing clinical study data so that it can be reliably analyzed and reported.
Bioexcel designs clinical data systems around the final evidence the study needs to produce.