Core Functions - Clinical Evidence

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 At Cardiovascular Lifesciences, we partner with cardiovascular MedTech innovators—whether you're an agile startup or a global market leader—to bring therapies to life with unmatched clinical and scientific precision. Our Medical Affairs team provides strategic guidance across every stage of your product’s lifecycle to ensure regulatory confidence, clinical relevance, and commercial success

Transforming data into influence.
We deliver high-impact, scientifically rigorous materials tailored for clinicians, regulators, and stakeholders.

• Literature reviews & evidence generation 
• Competitive intelligence gathering 
• Podium presentations & ICJME-compliant manuscripts 
• Regulatory briefing documents 

💡 Benefit to You: Amplify your product’s value through compelling, data-driven narratives.

Bridging innovation with clinical reality.
We identify and engage the right experts to validate and champion your technology.

• KOL strategy and relationship management 
• Medical advisory boards & scientific symposia 
• Conference coverage & virtual engagement sessions 

💡 Benefit to You: Build advocacy and accelerate early adoption through trusted clinical voices

Empowering teams. Educating clinicians. Enhancing outcomes.
We design tailored programs to build confidence and capability in your product.

• Sales force & commercial training 
• Physician workshops & wet labs 
• Onboarding, refresher, and launch training programs 

💡 Benefit to You: Enable informed adoption and drive usage from day one.

Sustaining value through post-market insight.
We manage post-approval strategies that ensure ongoing safety, efficacy, and payer alignment.

• Investigator-sponsored studies (ISS)
• Adverse event tracking & benefit-risk assessments 
• Global RWE generation with HEOR & market access support 

💡 Benefit to You: Support regulatory submissions, value-based pricing, and market expansion.

Delivering scientific answers—timely and compliant.
We handle the full spectrum of medical information needs.

• On-label & off-label inquiry management
• Validated response systems
• Scientific exchange via clinician discussions & site visits 

💡 Benefit to You: Build trust, maintain compliance, and engage clinicians effectively.

Our team acts as an extension of yours, ensuring that your innovations are safe and effective and that the cardiovascular community understands, embraces, and champions them.

We align science with strategy to support your clinical, regulatory, and commercial goals.

 Transforming Scientific Rigor into Market Success

At Cardiovascular Lifesciences, we deliver high-impact clinical trial strategy and oversight that helps cardiovascular innovators generate robust, regulator-ready evidence—accelerating product approvals, de-risking development, and improving time-to-market.

We partner with your internal teams to design and execute clinical trials that are scientifically sound, regulator-ready, and commercially relevant.

What We Offer:

• Comprehensive clinical research strategies across preclinical and Phases I–IV
• Protocol development, eCRF design, site selection, and IRB/EC approvals
• KPI-driven performance oversight of sites and CROs
• Clinical study budgeting, TMF oversight, informed consent development
• Statistical analysis review and clinical study report (CSR) authorship and approval 

Your Business Benefit:

✔ Accelerated trial start-up and execution
✔ Reduced protocol deviations and costly delays
✔ High-quality data for confident decision-making and submission

We bring deep experience in preparing clinical documentation that meets the rigorous standards of the U.S. FDA.

Our Capabilities Include:

• FDA IDE protocols and amendments 
• Clinical modules for PMA submissions
• Clinical Study Reports (CSRs), technical summaries, SSED development 
• Meeting preparation and FDA correspondence support

Your Business Benefit:

✔ Streamlined FDA interactions
✔ Greater likelihood of first-round approvals
✔ Clinical documentation aligned with evolving FDA expectations

Navigate EU MDR with confidence. We support clients in generating and evaluating clinical evidence in compliance with stringent European regulations for Class III and implantable devices.

Our Deliverables Include:

• Clinical Evaluation Plans (CEP), Clinical Investigation Plans (CIP)
• Clinical Evaluation Reports (CERs), PMCF Plans & Evaluation Reports
• State-of-the-art (SOTA) literature and competitor analysis
• Summary of Safety and Clinical Performance (SSCPs)
• Clinical Investigation Reports & post-approval evidence plans 

Your Business Benefit:

✔ Fast-tracked CE Mark submissions
✔ Robust, audit-ready documentation
✔ Reduced remediation risk during NB review

We ensure global regulatory, ethical, and scientific compliance—protecting trial integrity and safeguarding your pathway to approval.

We Support:

• Monitoring adherence to FDA, GCP, ISO14155, and global regulatory standards
• Review of monitoring reports, deviations, and site-level performance metrics
• Edit checks and query resolution across study databases 

Your Business Benefit:

✔ Minimized regulatory risks and rework
✔ Elevated trial quality and stakeholder confidence

We lead the medical oversight of your study, ensuring that safety signals are identified early and appropriately addressed.

We Provide:

• Oversight of Clinical Events Committees (CEC) and DSMBs
• Adverse event adjudication and safety board leadership
• SAE trend monitoring and benefit-risk analysis
• Periodic medical safety reviews and safety communication plans 

Your Business Benefit:

✔ Enhanced patient safety profile
✔ Clean, well-documented safety data for regulatory confidence
✔ Strengthened risk-benefit positioning for market access

We help you build clinical buy-in through transparent communication, effective training, and physician advocacy.

Our Approach:

• Clear communication of trial rationale, endpoints, and follow-up procedures
• Proctorship and physician ambassador programs to drive enrollment
• Ongoing investigator engagement and site-specific education 

Your Business Benefit:

✔ Improved enrollment rates and investigator retention
✔ Stronger clinical relationships to support launch and adoption
✔ Higher protocol compliance and cleaner data

• 30+ years in cardiovascular surgery, interventional cardiology, and global clinical trials
• Deep experience in Class III devices, IDE/PMA processes, and EUMDR clinical evidence
• Integrated expertise in clinical strategy, regulatory alignment, and market readiness