Clinical Research Services
Evidence-Based Support for Regulatory Success
Robust clinical evidence is fundamental to securing global medical device approvals. At PCS, we manage the entire clinical research continuum ,clinical research management encompassing protocol development ,clinical research management system trial execution, and post-market vigilance. Our seasoned professionals offer comprehensive biostatistical analysis and scientific documentation services, enabling you to produce credible data, substantiate device safety, and ensure regulatory adherence throughout your product's lifecycle.
Clinical Study Management (Design & Execution)
Clinical Evaluation Reports (CER) (In Line with MDR)
Post-Market Surveillance & Clinical Follow-Up (PMCF) (Ongoing Device Monitoring & Long-Term Data Collection)
Safety & Clinical Performance (Evaluating Benefits & Risks)
Clinical Investigation Report (Formal Assessment of Trial Data))
Periodic Safety Update Report (PSUR) (Regulatory Compliance Reporting)
Biostatistics & Medical Writing (Data Analysis & Documentation)
Your Compliance Journey – Simplified!
Our Five Step Journey Process
Contact PCS
Start with a quick consultation, get clarity instantly!
List Your Requirements
Share device details & compliance challenges.
Get a Quote
Transparent pricing. No surprises!
Kick-off Meeting
Strategies aligned, execution begins.
Approval & Execution
Deliverables on time, compliance achieved!
TESTIMONIALS
Words From Our Clients!"Pinnacle Compliance Solutions” has consistently demonstrated exceptional expertise and a proactive approach to navigating complex EU regulations. Their guidance has been instrumental in ensuring regulatory compliance and achieving significant success. I recommend Pinnacle Compliance Solutions for their reliable and timely regulatory support within the EU, which has been invaluable to your organization's strategic growth and operational efficiency.
M. Viswanathan
Senior Regulatory Manager
TESTIMONIALS
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Ruben Velez, MD
Duncan International Private Limited
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