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Identify Regulatory Pathways Early
Bioskills can be the initial entry point by identifying the regulatory pathway as you work through feasibility. Our cadaver lab helps establish clear development direction from the start.
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Fine-Tune Protocols
Helps explore different approaches to testing your device. Bioskills help work out any kinks before moving into formal testing, saving time and reducing development costs.
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Build Physician Confidence
Real-world surgical environments in our cadaver lab across all specialties. Physicians gain hands-on experience with anatomically accurate models.
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Most Accurate Patient Simulation
Cadaver simulates a patient in the most accurate environment. Cadaver represents your patient yesterday, today and tomorrow—providing unmatched training realism.
Stream Live Procedures Across Surgical Suites
Our AV system connects three ORs and a dedicated cath lab to three conference rooms in real time. Didactic sessions flow directly into live demonstrations, cutting training cycles and accelerating device consensus.
Schedule When Surgeons Can Attend
We operate evenings and weekends so physicians balance clinic commitments with hands-on training. Your key opinion leaders get the repetition they need to bring life-changing devices to patients with confidence.
Image Everything, Source Anything
A dedicated CT unit and two mobile OEC 9900 C-Arms with vascular packages deliver comprehensive imaging on-site. Our sourcing team procures or rents device-specific equipment within 48 hours, eliminating logistics delays.
Phase 1 Pharmacokinetic Protocol QC Review
Situation
Client needed comprehensive QC review of a Phase 1 clinical study protocol under urgent deadlines to ensure regulatory compliance and submission readiness. Challenges included:
- Stringent timeline constraints requiring rapid yet thorough review
- Complex Phase 1 PK protocol demanding precise technical accuracy
- External collaboration coordination with medical writer
- Comprehensive content verification including Schedule of Assessments
Successes
- Client satisfaction achieved - QC review delivery highly appreciated
- Timeline compliance - Met all urgent deadlines through efficient execution
- Protocol accuracy enhanced - Delivered error-free, submission-ready protocol
- Regulatory alignment ensured - All elements met industry standards
- Seamless collaboration established - Effective coordination with external writer
Services by Veranex
- Systematic QC approach with critical content reviews and robust checklists
- Comprehensive technical analysis identifying discrepancies and missing data
- Strategic planning framework to meet urgent timelines
- Definitive revision recommendations for seamless protocol flow
- Schedule of Assessments validation and timing table review
Source Document Processing Challenge Resolution
Situation
Client faced significant delays in regulatory publishing due to monitoring CRO point of contact issues. Challenges included:
- Monitoring CRO had inadequate awareness of scope, causing misinterpretations and delays
- Site-related source documents not provided within defined timelines
- CRO demanded out-of-scope activities from Veranex team
- Approximately 2,000 documents across 91 sites needed USFDA standard processing
Successes
- Document processing completed - Successfully processed ~2,000 documents across 91 sites
- Communication channels established - Efficient workflow between all parties
- Scope clarification achieved - Resolved misunderstandings and timeline delays
- CSR delivery accomplished - Clinical Study Report met regulatory requirements
- Ethical standards maintained - Highest standards throughout resolution process
Services by Veranex
- Comprehensive training on Veranex regulatory publishing process for all stakeholders
- Structured approach with regular meetings and documentation protocols
- Collaborative communication with client stakeholders and monitoring CRO
- Domain expertise application leveraging regulatory publishing knowledge
- Adaptive approach with patience and flexibility tailored to scenario
