Clinical Investigations Built Around the Evidence You Need
Bioexcel helps medical device manufacturers design and execute clinical investigations that generate scientifically robust, operationally reliable and regulatory-relevant clinical evidence.
Our integrated services include clinical strategy, protocol development, site feasibility, investigator selection, study start-up, monitoring, EDC, data management, biostatistics and Clinical Investigation Report preparation.
Does Bioexcel Conduct Medical Device Clinical Investigations?
Yes. Bioexcel supports medical device clinical investigations from evidence-gap assessment and CIP/protocol development through site feasibility, ethics and regulatory coordination, monitoring, EDC, data management, biostatistics and final clinical reporting.
Bioexcel Lifesciences & Research LLP is a specialized medical device and IVD clinical research organization supporting clinical investigations from study strategy and protocol development through site execution, monitoring, data management, biostatistics and regulatory-ready reporting.
Medical Device Clinical Investigations Require Device-Specific Evidence Design
Medical device investigations often differ from pharmaceutical trials because the evidence strategy may need to account for:
- Device design
- Intended purpose
- Implant duration
- User interaction
- Procedure dependency
- Operator learning curve
- Device deficiencies
- Technical success
- Procedural success
- Device-related complications
- Reintervention
- Long-term device performance
- State-of-the-art benchmarks
- CER and PMCF integration
Bioexcel therefore designs the investigation around the device's clinical and regulatory evidence question, rather than applying a generic drug-trial model.
What Type of Medical Device Clinical Study Does Your Product Need?
First-in-Human Clinical Investigation
Suitable for innovative technologies requiring initial evidence of safety, feasibility and early performance.
Potential Objectives
- Initial safety
- Technical feasibility
- Procedural feasibility
- Device performance
- Early clinical benefit
- Identification of device-related risks
Early Feasibility Study
Useful where initial clinical experience is required before a larger confirmatory investigation.
Potential Objectives
- Refine study procedures
- Evaluate device operation
- Identify early safety issues
- Assess endpoint feasibility
- Inform pivotal study design
Pivotal Clinical Investigation
Designed to generate confirmatory evidence supporting regulatory submission or conformity assessment.
Potential Features
- Defined primary endpoint
- Safety endpoints
- Performance endpoints
- Statistical hypothesis
- Multicenter execution
- Predefined follow-up
- Formal Statistical Analysis Plan
Prospective PMCF Study
Prospective clinical follow-up after market access to confirm continued device safety, performance and clinical benefit.
Explore Prospective PMCFRetrospective Clinical Study
Use existing clinical records from previously treated patients when the data can appropriately address the evidence objective.
Explore Retrospective StudiesMedical Device Registry
Structured long-term data collection for devices requiring ongoing surveillance or longitudinal outcome assessment.
Explore Registry StudiesWhat Types of Medical Device Studies Does Bioexcel Support?
Bioexcel supports first-in-human studies, early feasibility investigations, pivotal clinical investigations, prospective PMCF, retrospective studies, registries and other appropriately designed medical device evidence programs.
What clinical investigation services does Bioexcel provide?
Bioexcel provides clinical investigation strategy, protocol development, site feasibility, study start-up, monitoring, EDC, clinical data management, biostatistics, medical writing and final clinical reporting for medical device studies.
Where can Bioexcel support clinical investigations?
Bioexcel supports medical device clinical evidence programs in India and Europe, with centralized clinical, data, statistical and regulatory services for international sponsors.
Can Bioexcel support only part of a study?
Yes. Bioexcel can support full-service clinical investigations or individual functions such as monitoring, site management, data management, biostatistics or medical writing.
From Regulatory Question to Clinical Evidence
Evidence Gap Assessment
- Device description
- Intended purpose
- Regulatory market
- Existing clinical data
- Clinical Evaluation Report
- Risk Management
- PMS / PMCF
- Notified Body feedback
Output: Defined Clinical Evidence Requirement
Study Design
- Study objective
- Endpoints
- Study population
- Comparator
- Sample size
- Follow-up
- Statistical methodology
Output: Clinical Study Strategy
CIP / Protocol Development
- Clinical Investigation Plan
- Synopsis
- Study procedures
- Safety reporting
- Monitoring strategy
- Data strategy
- Statistical framework
Output: Study Documentation
Site Feasibility & Start-Up
- Country feasibility
- Hospital identification
- Investigator identification
- Ethics
- Applicable regulatory steps
- Contracts
- Budgets
- Site initiation
Output: Activated Study Sites
Study Execution
- Recruitment
- Clinical procedures
- Follow-up
- Monitoring
- Safety
- Device accountability
- Protocol compliance
Output: Reliable Clinical Data
Data & Biostatistics
- eCRF
- EDC
- Data review
- Queries
- Database lock
- Statistical analysis
Output: Validated Clinical Evidence
Clinical Reporting
- Clinical Investigation Report
- Statistical interpretation
- Study conclusions
- CER integration
- PMCF integration
Output: Regulatory-Ready Clinical Evidence
Start With the Clinical Question
Before recommending a study, Bioexcel can review available evidence to determine what information is actually missing.
Inputs
- IFU
- Device description
- Existing CER
- CEP
- Risk Management
- PMS
- PMCF
- Previous studies
- Literature
- Notified Body findings
Questions Addressed
- Is a new study needed?
- What should the study demonstrate?
- Which claims require clinical support?
- What follow-up is required?
- Which risks need confirmation?
- Can retrospective evidence help?
- Is PMCF more appropriate?
- Are existing studies sufficient?
Clinical Investigation Plan Development
Bioexcel can support development and review of the CIP.
- Study title
- Background
- Device description
- Clinical rationale
- Intended purpose
- Study objectives
- Primary endpoint
- Secondary endpoints
- Safety endpoints
- Study design
- Study population
- Inclusion criteria
- Exclusion criteria
- Device procedure
- Follow-up schedule
- Safety reporting
- Device deficiencies
- Monitoring
- Data management
- Statistical methodology
- Ethics
- Quality controls
Can Bioexcel Prepare a Clinical Investigation Plan?
Yes. Bioexcel can develop or review Clinical Investigation Plans for medical device studies, including study design, endpoint strategy, safety, monitoring, data management and statistical considerations.
Endpoints That Answer the Regulatory Question
Bioexcel helps define clinically relevant and statistically evaluable endpoints.
Safety Endpoints
- Serious adverse events
- Device-related events
- Procedure-related events
- Device deficiencies
- Reintervention
- Revision
- Hospitalization
- Mortality where relevant
Performance Endpoints
- Device success
- Technical success
- Procedural success
- Functional performance
- Device durability
- Anatomical outcome
Clinical Benefit
- Symptom improvement
- Functional improvement
- Quality of life
- Reduction in intervention
- Reduction in hospitalization
- Patient-reported outcomes
Statistical Planning Before Recruitment Begins
Bioexcel biostatistics support includes:
Can Bioexcel Calculate Sample Size for a Medical Device Study?
Yes. Bioexcel provides medical device sample-size calculations based on the study objective, endpoint, expected performance or event rate, statistical power, precision requirements and anticipated attrition.
Selecting Sites That Can Deliver the Study
Bioexcel feasibility can evaluate:
Investigator
- Relevant specialty
- Device experience
- Clinical research experience
- Procedure expertise
- Availability
Patient Population
- Eligible population
- Procedure volume
- Recruitment potential
- Competing studies
- Follow-up potential
Infrastructure
- Procedure rooms
- Cath lab / OT where applicable
- Imaging
- Laboratory
- ICU
- Device storage
- Research team
Operations
- Ethics Committee
- Contract timelines
- Site budget
- Data access
- Monitoring readiness
Can Bioexcel Identify Hospitals and Investigators?
Yes. Bioexcel can conduct site feasibility to identify suitable hospitals and investigators based on the device, indication, patient population, study design and operational requirements.
Already Have a Hospital or Investigator?
Bioexcel can work with a sponsor-selected site.
- Feasibility confirmation
- Protocol implementation
- Start-up
- Ethics coordination
- Site initiation
- Monitoring
- Data management
- Statistics
- Clinical reporting
Can Bioexcel Manage a Site Selected by the Sponsor?
Yes. Where the sponsor already has a hospital or investigator, Bioexcel can provide the required clinical operations, monitoring, data, biometrics and reporting support depending on the agreed scope.
Clinical Study Start-Up
Bioexcel can coordinate:
- Investigator documentation
- Site documents
- Essential documents
- Ethics package
- Regulatory documentation
- Contracts
- Budgets
- Training
- EDC access
- Site initiation
- Recruitment planning
Ethics and Regulatory Support
Study-specific pathways may involve:
- Ethics Committee / IRB
- Institutional review
- Competent authority or CDSCO requirements where applicable
- Local regulatory requirements
- Data privacy requirements
Bioexcel can support document preparation, submission coordination and query responses according to the applicable country and study pathway.
Medical Device Clinical Monitoring
Monitoring can include:
- Site initiation
- Interim monitoring
- Remote monitoring
- Source data review
- Consent review
- Eligibility review
- Safety review
- Device accountability
- Protocol deviation review
- CRF review
- Query follow-up
- Site close-out
Does Bioexcel Provide Clinical Monitoring?
Yes. Bioexcel supports medical device clinical monitoring using on-site, remote or hybrid models depending on the study design, site requirements and monitoring strategy.
Safety in Medical Device Investigations
Bioexcel can support study workflows involving:
- Adverse events
- Serious adverse events
- Device-related events
- Procedure-related events
- Device deficiencies
- Safety reconciliation
- Investigator follow-up
- Ethics/regulatory safety submissions where applicable
- Safety analysis
Device Traceability During the Study
Study-specific device accountability may include:
- Device receipt
- Device identification
- Lot / batch
- Serial number
- Site inventory
- Device use
- Return
- Destruction where applicable
- Device deficiency documentation
From First Patient to Database Lock
Bioexcel supports:
- Data Management Plan
- CRF/eCRF
- EDC
- Edit checks
- Data review
- Query management
- Safety reconciliation
- Data cleaning
- Database lock
- Statistical dataset
Can Bioexcel Provide EDC and Data Management for the Study?
Yes. Bioexcel can provide eCRF design, EDC configuration, clinical data management, query management, data cleaning and database lock for medical device clinical investigations.
Statistical Analysis of Clinical Evidence
Potential analyses may include:
Clinical Documentation Across the Study Lifecycle
Pre-Study
- Synopsis
- CIP
- Protocol
- ICF / PIS
- CRF content
During Study
- Protocol amendments
- Safety narratives
- Study updates
Post-Study
- Clinical Investigation Report
- Publication support
- CER integration
- PMCF documentation
- Regulatory responses
From Clinical Data to Final Study Conclusions
Bioexcel can support preparation of the Clinical Investigation Report using finalized study data and statistical outputs.
- Executive summary
- Device information
- Study design
- Study population
- Subject disposition
- Baseline characteristics
- Protocol deviations
- Device exposure
- Primary endpoint
- Secondary endpoints
- Safety results
- Device deficiencies
- Statistical analysis
- Discussion
- Limitations
- Conclusions
Can Bioexcel Prepare the Clinical Investigation Report?
Yes. Bioexcel can prepare Clinical Investigation Reports using finalized study documentation, clinical data and statistical outputs, with interpretation aligned to the study objectives and intended regulatory use.
The Study Should Feed the Clinical Evaluation
Clinical investigation results can become a key input to the Clinical Evaluation Report.
Clinical Investigation and Post-Market Evidence
Where relevant, study results can help:
- Close previous CER gaps
- Refine PMCF strategy
- Confirm known risks
- Identify residual uncertainties
- Support long-term follow-up planning
Medical Device Studies in India
Bioexcel supports suitable clinical programs in India through:
- Site feasibility
- Investigator identification
- Study start-up
- Monitoring
- Data management
- Biostatistics
- Medical writing
Can Bioexcel Conduct Medical Device Studies in India?
Yes. Bioexcel supports medical device clinical investigations through suitable Indian hospitals and investigators, with centralized project management, monitoring, data management, statistics and reporting.
Medical Device Clinical Programs in Europe
Bioexcel supports European evidence programs through suitable local clinical resources combined with centralized Bioexcel clinical, data and regulatory support.
- European site feasibility
- Investigator identification
- Ethics/regulatory coordination
- Site initiation
- Monitoring
- Data management
- Statistics
- Reporting
Can Bioexcel Support Clinical Investigations in Europe?
Yes. Bioexcel supports European medical device clinical programs through appropriate local clinical resources combined with centralized project management, data management, biostatistics and regulatory evidence support.
Clinical Evidence for Complex Medical Devices
Bioexcel can support evidence programs involving:
- Cardiovascular implants
- Structural heart devices
- Coronary devices
- Vascular devices
- Orthopedic implants
- Spine implants
- Surgical robotics
- Urology devices
- Long-term implantables
- Other higher-risk technologies
Medical Device Clinical Expertise
Flexible Clinical Investigation Support
Full-Service CRO
Bioexcel supports strategy through final report.
Clinical Operations Only
Sponsor retains strategy; Bioexcel supports sites and monitoring.
Biometrics Only
Bioexcel supports EDC, data management and statistics.
Medical Writing / Regulatory Only
Bioexcel supports study documentation and final evidence outputs.
Why Medical Device Manufacturers Work With Bioexcel
Medical Device Focus
Clinical studies are structured around device-specific evidence requirements.
Clinical + Regulatory Integration
Study design considers how the evidence will eventually support CER, PMCF or submission needs.
Full Evidence Lifecycle
Strategy, operations, data, statistics and medical writing can remain connected.
Flexible Delivery
Full-service or functional support.
India + Europe
Cross-border clinical evidence options.
Relevant Clinical Investigation Experience
Frequently Asked Questions About Medical Device Clinical Investigations
A medical device clinical investigation is a systematic study involving human subjects designed to assess the safety, performance or clinical benefit of a medical device.
Bioexcel designs and executes medical device clinical investigations around the evidence the manufacturer ultimately needs to defend.