About Us
At Mixenra Consulting, we believe that excellence in clinical research and regulatory operations comes from a blend of expertise, precision, and a deep understanding of the needs of every client. Our mission is to empower organizations with tailored solutions that streamline operations, ensure compliance, and deliver results that truly make an impact.
Mission
We partner with pharmaceutical and biotech companies to deliver expert guidance, ensure compliance, and drive successful clinical research from start-up through study completion.
What Sets Us Apart
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Proven Expertise – Extensive experience across clinical trials (Phase I–IV), FDA and Health Canada regulatory affairs, ICH-GCP compliance, vendor management, and CRO collaborations.
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Specialized Knowledge – Deep expertise in oncology studies and clinical trial operations, with advanced skills in leading CTMS platforms (Medidata, Veeva Vault, Medrio, InForm, Oracle, Pro Pharma) and User Acceptance Testing (UAT) for system builds and revisions.
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Efficiency & Quality – Driving operational excellence through faster trial start-up, streamlined protocol development, and cost-effective solutions—all while upholding the highest compliance standards.
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Flexibility & Customization – Delivering tailored strategies that adapt to each client’s unique requirements, ensuring scalable, practical, and results-driven outcomes.
Skills & Capabilities
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Clinical Trial Operations – Coordination of oncology and multi-therapeutic trials, including study design and protocol development across Phases I–IV.
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Regulatory Submissions – Preparation and management of IND, CTA, NDA, and other regulatory filings in compliance with FDA, Health Canada, and ICH-GCP standards.
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Site Management – Expertise in site selection, feasibility assessments, and patient recruitment strategies, with proven success in oncology trial enrollment.
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Process Optimization – Development and implementation of streamlined workflows, SOPs, and best practices to improve operational efficiency.
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Data & Quality Oversight – Data management, verification, and quality control to ensure accuracy, compliance, and audit readiness.
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Vendor & CRO Management – Skilled in overseeing vendors, managing CRO partnerships, and maintaining effective sponsor communication.
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Risk Management & Monitoring – Proactive identification of risks and implementation of monitoring strategies to safeguard trial integrity.
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System Expertise – Advanced experience with User Acceptance Testing (UAT) and implementation of CTMS platforms and eClinical systems.
Credentials & Professional Background
At Mixenra Consulting, our team brings together a strong academic and professional foundation with diverse expertise across the life sciences industry. Collectively, our consultants hold Bachelor’s, Master’s, and PhD degrees in relevant scientific and clinical disciplines, along with industry-recognized certifications such as SOCRA.
Our professional experience spans roles within pharmaceutical and biotechnology companies as well as global CROs, where we have supported the successful execution of clinical trials from early development through late-stage commercialization. This background provides us with a comprehensive understanding of the challenges faced by sponsors and the strategies required to navigate them effectively.
With a proven record of advancing projects in compliance with international regulatory standards, our team combines scientific expertise, operational insight, and regulatory knowledge to deliver solutions that drive efficiency, ensure quality, and maintain compliance at every stage of clinical research.
Case Studies & Impact Highlights
1. End-to-End Sample Tracking System
Challenge: A sponsor running a large-scale oncology trial had no clear oversight of thousands of patient samples collected across global sites over a 4-year period. Critical gaps existed—whether samples were collected, shipped, stored, processed, or analyzed.
Solution: We developed and implemented a centralized tracking system to monitor every step of the sample lifecycle.
Impact: Provided full visibility, improved accountability, and ensured compliance with ICH-GCP and regulatory requirements. The sponsor gained real-time access to accurate sample status, preventing data loss and costly delays.
2. Turnaround Time Optimization
Challenge: Trial operations faced long cycle times due to fragmented workflows and delayed communication across stakeholders.
Solution: Streamlined communication, restructured workflows, and implemented process automation where applicable.
Impact: Reduced turnaround times by over 40%, accelerating protocol amendments, query resolutions, and database lock timelines. This allowed faster trial progress and earlier decision-making for critical milestones.
3. Cost Savings Through Multi-Role Expertise
Challenge: Sponsors were incurring high costs from multiple vendors and redundant staffing for overlapping roles.
Solution: Provided expertise across regulatory, data management, monitoring, and vendor oversight functions under a single consultant framework.
Impact: Saved the sponsor an estimated $250,000 annually in staffing costs by consolidating roles while increasing operational efficiency and reducing inter-team delays.
4. Vendor & CRO Oversight in Oncology Trials
Challenge: A global oncology study struggled with fragmented vendor deliverables (labs, CRO, EDC vendors), causing delays and compliance risks.
Solution: Introduced a governance structure and oversight process with clearly defined KPIs, escalation pathways, and performance metrics.
Impact: Improved vendor accountability, cut reporting delays by 30%, and strengthened compliance with both FDA and Health Canada requirements.
Future Vision
At Mixenra Consulting, we believe the future of clinical research lies in innovation, adaptability, and patient-centered solutions. Our vision is to stay at the forefront of an evolving industry—helping clients not only meet today’s challenges but also prepare for tomorrow’s opportunities.
We embrace digital health solutions and decentralized clinical trials (DCTs) to bring studies closer to patients, improving accessibility and diversity in participation. By leveraging artificial intelligence (AI) and machine learning (ML) in data management, we help sponsors uncover insights faster, enhance data quality, and streamline decision-making.
Our commitment to patient-centric design ensures that trial protocols are not only scientifically rigorous but also practical and compassionate—prioritizing participant experience while meeting regulatory and operational demands.
Looking ahead, Mixenra Consulting is dedicated to being a trusted partner for organizations seeking to navigate the next generation of clinical trials. Our long-term value lies in anticipating industry shifts, adopting cutting-edge technologies, and delivering flexible, compliant, and efficient solutions that drive both clinical and business success.
