Find Sites That Can Actually Deliver the Study
Bioexcel helps medical device and IVD manufacturers identify and activate suitable hospitals, investigators and laboratories based on the actual clinical evidence requirement, recruitment needs, procedure volume, historical device use and study infrastructure.
Our feasibility process is designed to reduce the risk of selecting sites that look strong on paper but cannot meet recruitment, data or follow-up expectations.
Does Bioexcel Provide Site Feasibility for Medical Device Studies?
Yes. Bioexcel provides site feasibility and study start-up support for medical device and IVD studies, including hospital and investigator identification, recruitment assessment, infrastructure review, site qualification, ethics coordination and site initiation.
Bioexcel Lifesciences & Research LLP provides site feasibility and study start-up services for medical device and IVD clinical programs, including hospital and investigator identification, recruitment assessment, infrastructure review, site qualification, ethics coordination, contracting and site initiation.
A Poor Site Can Compromise the Entire Study
Common site-selection risks include:
- Insufficient eligible patients
- Low procedure volume
- Investigator overcommitment
- Weak follow-up
- Inadequate research staff
- Poor source documentation
- Limited device experience
- Missing laboratory capability
- Long ethics timelines
- Difficult contracting
- Limited monitoring access
- Historical records unsuitable for retrospective research
Bioexcel therefore evaluates sites against the protocol and evidence requirement, not only reputation.
From Study Requirement to Activated Site
Study Requirement Review
- Device / IVD
- Indication
- Population
- Endpoints
- Sample size
- Follow-up
- Procedures
- Target geography
Output: Site Requirement Profile
Country / Region Screening
- Patient availability
- Clinical practice
- Investigator expertise
- Regulatory/ethics pathway
- Cost
- Timeline
Output: Preferred Geography
Site Identification
- Hospitals
- Specialty centers
- Investigators
- Laboratories
- Biobanks where applicable
Output: Long List
Feasibility Questionnaire
- Patient volume
- Procedure volume
- Historical device use
- Recruitment capability
- Infrastructure
- Staff
- Ethics information
Output: Feasibility Responses
Site Evaluation
- Recruitment
- Expertise
- Infrastructure
- Timelines
- Cost
- Data quality
Output: Short List
Qualification
- Qualification call
- Remote qualification
- On-site qualification where required
Output: Qualified Site
Start-Up
- Essential documents
- Ethics
- Regulatory requirements
- Budget
- Contract
Output: Start-Up Complete
Site Initiation
- Investigator
- Coordinator
- Study team
Output: Activated Site
Recruitment Launch
- First patient
- Screening
- Enrollment
Output: Operational Site
What Does Bioexcel Assess During Site Feasibility?
Bioexcel assesses patient or specimen availability, procedure volume, investigator expertise, research experience, infrastructure, follow-up capability, Ethics Committee readiness, contracting timelines, source-data access and overall ability to execute the study.
What site feasibility services does Bioexcel provide?
Bioexcel provides hospital and investigator identification, recruitment assessment, procedure-volume review, site qualification, IVD sample feasibility, ethics coordination and study start-up for medical device and IVD studies.
Can Bioexcel support both feasibility and activation?
Yes. Bioexcel can take a site from initial feasibility through qualification, ethics, contracting, initiation and activation.
Can Bioexcel support retrospective PMCF feasibility?
Yes. Bioexcel can identify hospitals with historical device use and evaluate whether existing records contain the endpoints required for retrospective PMCF.
Define What the Site Must Be Able to Do
Before approaching hospitals, Bioexcel can prepare a Site Requirement Profile. Potential requirements:
- Specialty
- Annual procedure volume
- Eligible patient population
- Study population
- Device experience
- Required imaging
- Required laboratory
- ICU support
- Operating theatre
- Cath lab
- Sample storage
- Long-term follow-up
- Research coordinator
- Ethics Committee
- Monitoring access
This improves the quality of site outreach.
Hospital and Investigator Identification
Bioexcel can identify potential sites through:
- Clinical specialty
- Investigator experience
- Procedure volume
- Study indication
- Device use
- Previous clinical research
- Regional accessibility
- Sponsor requirements
Can Bioexcel Identify Hospitals and Investigators?
Yes. Bioexcel can identify and evaluate hospitals and investigators based on the device, indication, patient population, procedure requirements, study design and target geography.
Collect Comparable Data From Every Potential Site
A feasibility questionnaire may include:
Investigator
- Specialty
- Qualification
- Years of experience
- Device experience
- Clinical-study experience
- Current study workload
Patient Population
- Monthly patient count
- Procedure count
- Expected eligible patients
- Recruitment estimate
Infrastructure
- OT / cath lab
- Imaging
- Laboratory
- Sample storage
- Emergency facilities
Site Team
- CRC
- Nurses
- Technicians
- Research staff
Ethics / Start-Up
- Ethics Committee
- Meeting frequency
- Submission timeline
- Contracting timeline
Data
- Source records
- EHR / paper records
- Monitoring access
- Retrospective data availability
Recruitment Estimates Should Be Evidence-Based
Bioexcel can assess:
- Total patient pool
- Disease prevalence
- Procedure volume
- Inclusion/exclusion impact
- Competing studies
- Investigator workload
- Expected consent rate
- Follow-up commitment
Example
Hospital sees:
100 relevant patients/month
Protocol eligibility may reduce this to:
25 potentially eligible
Consent/follow-up assumptions may reduce this further to:
10 realistic enrollments/month
The feasibility should use the realistic number.
Can Bioexcel Estimate Recruitment at a Clinical Site?
Yes. Bioexcel can estimate realistic recruitment based on patient volume, procedure volume, eligibility criteria, competing studies, investigator capacity, consent assumptions and expected follow-up.
Important for Procedure-Dependent Medical Devices
For devices involving:
- Monthly procedure volume
- Investigator procedure volume
- Relevant device use
- Case complexity
- Operator experience
Experience With the Device or Procedure Can Influence Study Quality
Feasibility may assess:
- Prior use of similar device
- Experience with investigational device
- Learning curve
- Training requirement
- Procedure success
- Device handling capability
For novel devices, additional training may be required before activation.
Historical Device Use Is the Starting Point
For retrospective PMCF, Bioexcel can assess:
- How many devices were used?
- During which years?
- Can patients be identified?
- Is device model recorded?
- Is lot/serial information available?
- Are follow-up records available?
- Are complications recorded?
- Is revision/reintervention documented?
- Are imaging records available?
- Can the hospital provide source access?
Can Bioexcel Find Hospitals With Existing Device Records for Retrospective PMCF?
Yes. Bioexcel can identify and assess hospitals based on historical device use, patient-record availability, follow-up duration, endpoint availability and operational feasibility for retrospective PMCF.
Sites for Prospective Post-Market Evidence
For prospective PMCF, assess:
- Current device use
- Annual patient volume
- Investigator familiarity
- Follow-up
- Long-term patient retention
- Routine clinical assessments
- PMCF endpoint availability
Clinical Sites and Laboratories for Diagnostic Studies
IVD feasibility may assess:
Participant Pool
- Target disease
- Positive cases
- Negative controls
- Clinical setting
Samples
- Specimen type
- Sample count
- Sample volume
- Fresh vs archived
- Storage
Reference Testing
- Comparator method
- Laboratory infrastructure
- Reference analyzer
- Molecular testing
- Sample handling
Can Bioexcel Identify Sites for IVD Clinical Performance Studies?
Yes. Bioexcel can evaluate clinical sites and laboratories based on target participant population, specimen availability, reference-testing capability, sample processing and study-specific clinical performance requirements.
Can the Site Supply the Required Specimens?
For IVD studies, feasibility may capture:
- Positive samples
- Negative samples
- Weak positives
- Near-cutoff samples
- Serotypes
- Genotypes
- Disease controls
- Cross-reactive conditions
Match Infrastructure to the Protocol
Cardiovascular
- Cath lab
- Echocardiography
- CT/MRI
- ICU
Orthopedics
- OT
- Radiology
- Rehabilitation
IVD
- Laboratory
- Centrifuge
- Freezer
- Molecular lab
- Sample storage
Surgical Robotics
- Compatible operating theatre
- Trained surgical team
- Equipment support
The Principal Investigator Is More Than a Name on the CV
Bioexcel can assess:
- Relevant specialization
- Procedure experience
- Device experience
- Clinical research history
- Trial workload
- Availability
- Study interest
- Recruitment access
- Team support
Verify the Feasibility Before Final Selection
Site qualification can confirm:
- Feasibility answers
- Facilities
- Patient flow
- Study staff
- Equipment
- Source documentation
- Ethics setup
- Monitoring arrangements
- Device/sample storage
What Is the Difference Between Feasibility and Qualification?
Feasibility assesses whether a site appears capable of conducting the study, while qualification confirms that the shortlisted site has the required facilities, personnel, documentation, patient or specimen access and operational readiness before final selection.
Compare Sites Using Objective Criteria
| Criteria | Weight | Site A | Site B | Site C |
|---|---|---|---|---|
| Patient availability | 25% | 5 | 4 | 3 |
| Investigator expertise | 20% | 5 | 4 | 5 |
| Infrastructure | 15% | 4 | 5 | 4 |
| Ethics timeline | 10% | 4 | 3 | 5 |
| Recruitment commitment | 15% | 5 | 4 | 3 |
| Follow-up potential | 15% | 4 | 5 | 4 |
Illustrative example only — actual site scores remain internal unless sponsor-approved.
Move From Selected Site to Activated Site
Bioexcel can coordinate:
- Investigator documents
- Site documents
- Protocol
- ICF/PIS
- Insurance documentation where applicable
- Ethics submission
- Applicable regulatory submissions
- Contracts
- Budget
- EDC access
- Training
- Site initiation
Ethics Submission Coordination
Potential documentation:
- Protocol
- Synopsis
- ICF / PIS
- Investigator CV
- Device information
- Safety information
- Insurance/compensation documentation where applicable
- Recruitment material
- CRF
- Sponsor documentation
Study-Specific Regulatory Pathway
Requirements can differ based on:
- Country
- Device classification
- Market status
- Study type
- Pre-market vs post-market
- IVD vs medical device
Bioexcel can support study-specific regulatory planning and submission coordination.
Site Agreement Management
Potential elements:
- Scope
- Responsibilities
- Payment terms
- Confidentiality
- Data access
- Monitoring
- Publication
- Study termination
- Record retention
Bioexcel can coordinate contract discussions between sponsor and site depending on project scope.
Budget Should Reflect the Actual Study Workload
Potential cost components:
- PI fee
- Study coordinator
- Procedures
- Follow-up visits
- Imaging
- Laboratory tests
- Sample processing
- Record abstraction
- Ethics fees
- Pharmacy/device storage
- Archiving
- Administrative costs
Can Bioexcel Negotiate Site Budgets?
Yes. Bioexcel can support site-budget development and negotiation based on protocol procedures, patient visits, site workload and study-specific pass-through costs.
Start-Up Documentation Should Be Complete Before Activation
Potential documents:
- Investigator CV
- GCP/training records
- Medical registration
- Financial/conflict disclosures where applicable
- Delegation information
- Ethics approval
- Site agreement
- Laboratory certifications where applicable
- Site contact list
- Training documentation
Activate the Site With Clear Study Expectations
Site initiation should cover:
- Study rationale
- Protocol
- Eligibility
- Recruitment
- Device
- Study procedures
- Safety
- Device deficiencies
- EDC
- Queries
- Monitoring
- Essential documents
Can Bioexcel Conduct Site Initiation?
Yes. Bioexcel can conduct or coordinate site initiation to ensure the investigator and study team understand the protocol, device, data, safety and operational requirements before enrollment begins.
Confirm Readiness Before Recruitment Starts
Need Only One Site?
Bioexcel can support targeted one-site studies. Potential scenarios:
- Sponsor-selected hospital
- Specialized investigator
- Targeted PMCF
- Small IVD study
- Surgical robotics program
- Specialist indication
Can Bioexcel Activate Only One Site?
Yes. Bioexcel can support single-site studies when one qualified site can meet the recruitment, data and evidence requirements.
Standardize Start-Up Across Multiple Hospitals
Bioexcel can centrally coordinate:
- Feasibility
- Site selection
- Documents
- Contracts
- Budgets
- Ethics
- Training
- EDC
- Initiation
Site Dashboard
Medical Device & IVD Sites in India
Bioexcel supports India site feasibility based on:
- Patient volume
- Procedure volume
- Historical device use
- Investigator expertise
- Clinical infrastructure
- IVD specimen access
- Long-term records
Can Bioexcel Find Medical Device Clinical Sites in India?
Yes. Bioexcel can identify and evaluate suitable Indian hospitals and investigators based on the specific study design, indication, patient population and operational requirements.
European Clinical Site Identification
Bioexcel can support European feasibility through suitable local resources based on:
- Country suitability
- Patient population
- Investigator expertise
- Clinical practice
- Regulatory/ethics pathway
- Study timeline
- Site cost
Can Bioexcel Identify European Medical Device Sites?
Yes. Bioexcel can support European country, site and investigator feasibility through appropriate local resources combined with centralized study planning.
Global Strategy. Regionally Efficient Execution.
Bioexcel combines centralized clinical and regulatory management with qualified sites, investigators, laboratories and specialist partners across India and Europe.
India execution
Cost-efficient study delivery where scientifically and regulatorily appropriate
European execution
EU sites and populations for market-specific requirements
Hybrid execution
Bioexcel central management with European partner-network site execution
Multiregional planning
Evidence strategy designed for more than one regulatory market
Sponsor Has the Site—Bioexcel Handles the Operations
Can Bioexcel Work With a Site Already Selected by the Sponsor?
Yes. Bioexcel can assess readiness and provide the required clinical-operations, monitoring, data and reporting support for sponsor-selected sites.
Not Ready to Award the Full Study?
Sponsors may engage Bioexcel initially for:
- Country feasibility
- Site feasibility
- Investigator feasibility
- Patient recruitment estimates
- Sample feasibility
- Indicative site budgets
- Timeline assessment
Output
Clinical Study Feasibility Report
Can Bioexcel Provide Only Site Feasibility?
Yes. Bioexcel can conduct standalone site and study feasibility before the sponsor commits to full study execution.
Recommended Deliverable
- Study Requirement
- Geographic Assessment
- Shortlisted Sites
- Investigator Expertise
- Patient / Sample Availability
- Recruitment Estimate
- Infrastructure
- Ethics Timeline
- Site Budget Estimate
- Key Risks
- Recommended Sites
- Next Steps
Flag Risk Before Site Activation
LOW RISK
Strong patient pool + experienced investigator
MEDIUM RISK
Adequate patient pool but operational limitations
HIGH RISK
Low recruitment, weak records or significant start-up issues
This helps the sponsor make an evidence-based site decision.
The Site Team Should Not Disappear After Selection
This creates continuity between the promises made during feasibility and actual study performance.
Confirm the Site Can Generate the Required Data
Before selection, confirm:
- Required endpoints exist
- Source records exist
- Data can be entered into EDC
- Historical records are accessible
- Follow-up data are available
- Lab results can be matched
- Sample IDs are traceable
Sites for Complex MedTech Programs
Cardiovascular & Structural Heart
Orthopedics & Spine
Surgical Robotics
Urology
IVD
Why MedTech Sponsors Use Bioexcel for Site Feasibility
Device & IVD Focus
Site questions reflect the actual evidence requirements.
Recruitment-Based Selection
Patient volume is converted into realistic recruitment potential.
Retrospective Capability
Historical device-use and record availability can be assessed.
IVD Sample Feasibility
Sites can be evaluated for sample and reference-testing capability.
India + Europe
Cross-regional site feasibility.
Full Start-Up Support
Feasibility can continue directly into site activation and monitoring.
Site Feasibility Deliverables
Depending on scope:
- Country feasibility assessment
- Site Requirement Profile
- Site long list
- Investigator list
- Site Feasibility Questionnaire
- Completed feasibility responses
- Feasibility comparison matrix
- Site recommendation
- Site Qualification Report
- Recruitment estimate
- Sample feasibility report
- Site budget assessment
- Start-up tracker
- Ethics tracker
- Contract tracker
- Essential-document tracker
- SIV report
- Site activation confirmation
Site Feasibility in Practice
Implantable Cardiac Device
Requirement: Retrospective long-term evidence
Feasibility Focus: Historical device use, follow-up and medical records
IVD Rapid Test
Requirement: Positive and negative specimens
Feasibility Focus: Patient/sample availability, reference method and laboratory capability
Sponsor-Selected Hospital
Requirement: One-site prospective study
Bioexcel Role: Site readiness assessment, start-up and operational support
Frequently Asked Questions About Site Feasibility
Yes. Bioexcel provides site feasibility for medical device, PMCF and IVD clinical programs.
Bioexcel selects sites according to their ability to generate the required clinical evidence—not simply their name or location.