services
Clinical, Quality & Regulatory
The specialized team at Arete supports clinical diagnostics and medical device industries by managing clinical trials, quality systems and audits, and regulatory strategy. We ensure compliant, efficient product development from concept to commercialization, offering flexible support through collaborative consulting or fully outsourced functions.
Overview
Backed by decades of collective experience, Arete supports clinical trials, quality systems, product development, and global regulatory strategy with a hands-on, collaborative approach from concept through launch. We integrate closely with client teams to navigate complex requirements, reduce risk, and generate the evidence needed to achieve regulatory approval with confidence.
Why Arete?
By embedding clinical, quality, and regulatory experts as early as possible, we become a seamless extension of your team. This hands-on collaboration powers smarter strategies, rooted in a deep understanding of your product, your users, and your goals. From day one of our partnership, we craft practical, efficient, and end-user focused approaches that drive compliance and accelerate your path to market success.
our expertise
Clinical Strategy & Support
We design and manage studies that are efficient, operationally sound, and aligned with regulatory and commercial goals, from concept through data reporting.
Quality System Development &
Certified Audit Services
Certified Audit Services
Our team builds and implements audit-ready 21 CFR and ISO 13485-compliant QMS tailored to your organization’s size, maturity, and risk profile, while also offering certified auditing services to help you proactively identify gaps, withstand inspections, and maintain continuous compliance.
Regulatory Strategy & Market Access
We navigate the full regulatory lifecycle for FDA, IVDR, and global pathways with proactive planning, clear documentation, and hands-on regulatory engagement to drive timely approvals.
Services Overview
Boutique CRO Services
Where science meets strategy — building assays and core technologies that set the stage for everything that follows.
- Customized clinical trial planning and execution, from pre-clinical studies to post-market surveillance
- Strategic study design aligned with regulatory and commercial objectives
- Full coordination of site management, monitoring, and data collection
- Vendor selection and oversight, with transparent communication and accountability
- Cross-functional coordination between clinical, regulatory, and quality functions
- Support for under-resourced teams or emerging companies needing capacity and expertise
Customized Execution
Seamless Coordination
Scalable Support
Clinical Affairs
Strategic clinical guidance to strengthen your development plans and submission package.
- KOL and investigator engagement strategy development
- Creation or gap analysis of clinical study conduct operating procedures and templates
- Development of clinical development plans aligned with product and regulatory strategy
- Guidance on clinical evidence requirements for regulatory submissions and market access
- Advisory on clinical endpoints, study populations, and feasibility in diagnostics
- Evaluation and optimization of clinical workflows
- Clinical due diligence for partnerships, acquisitions, or funding rounds
Study Feasibility
Clinical-Regulatory Sync
Strategic Guidance
Custom Clinical Data Systems
Efficient, compliant platforms built to fit your study and scale with your needs.
- Build, design, and deploy 21 CFR Part 11 compliant electronic databases
- Deliver complete eCRF build specifications and user acceptance testing (UAT) reports
- Enable secure electronic informed consent (eConsent) workflows
- Provide custom dashboards and ongoing clinical data analysis to support regulatory and business decision-making
- Maintain in-house Certified Database Administrator and Builder for responsive, expert support
Compliant Platforms
eCRF & eConsent
Real-Time Insights
Clinical Operations & Data Management
Coordinated clinical execution, from site activation to clean data and sample logistics.
- Activate and monitor clinical sites, ensuring trials run smoothly, safely, and in compliance with protocols, GCP guidelines, and regulatory requirements.
- Develop data management and statistical analysis plans with final report generation
- Design CRFs for efficient and accurate data collection
- Compile and organize study line data
- Procure specimens to support all phases of product development
- Store clinical samples at our Carlsbad, CA-based biorepository
Full Trial Oversight
Clean Data
Sample Logistics
Quality Management System Support & Compliance
Scalable, audit-ready quality systems aligned with regulatory expectations.
- Build ISO 13485:2016 / 21 CFR 820-compliant QMS from the ground up
- Create ISO 14971-compliant risk management files
- Support document control and quality documentation processes
- Guide eQMS selection, validation, and rollout
- Review batch and manufacturing records for audit readiness
- Serve as quality representative on cross-functional product development teams.
Audit-Ready QMS
Risk Management
Document Control
Certified Auditing Services
Clear, professional and thorough analysis and guidance to strengthen your Quality Systems, promote continuous improvement and meet external audit goals.
- Conduct thourough and informative internal audits
- Perform system, process and product audits to ensure robust processes lead to safe, compliant products suitable for release
- Identify gaps in Quality Management System to regulations and standards (ISO, MDSAP, QMSR)
- Determine QMS audit readiness through thorough analysis and evaluation of processes, records and systems for compliance with national and international standards
- Provide feedback for Quality Management System improvement to ensure favorable audit outcomes
Quality Audits
QMS Gap Analysis
Continuous Improvement
Regulatory Affairs
Smart, focused regulatory strategy to help you reach the right markets.
- Craft targeted regulatory strategies aligned with product and market needs and assist in defining intended use
- Lead FDA submissions: Q-Sub, 510(k), De Novo, CLIA Waiver, and more
- Navigate U.S. pathways for OTC, POC, and moderate and high-complexity diagnostics
- Review labeling for regulatory accuracy and compliance
- Develop Operator’s Manuals, IFUs, QRIs to meet FDA requirements and de-risk execution of studies
- Support the development of product naming conventions and system definitions to promote consistency, traceability, and regulatory clarity across documentation, submissions, and lifecycle management.
Targeted Strategy
FDA Submissions
Labeling Compliance
Verification Strategy & Execution
From study design to execution, we support every step of verification with scientific and regulatory rigor.
- Design FDA-submissible verification studies specific to your product
- Interpret FDA feedback and adjust study design for alignment and approval readiness
- Develop Design History File (DHF) documentation to support regulatory submissions
- Plan and execute Flex and Usability studies as required by device classification
- Offer flexible execution models: we can run studies, place experts on-site, or equip your team with ready-to-go documentation
- Define and justify product specifications with data-driven methodologies
- Develop and refine QC testing methods to support manufacturing and release
FDA-Ready Studies
Practical Execution
Usability Testing
Testimonial
My team and I have had the pleasure of working closely with the team at Arete Biosciences over the past couple of years. Arete embedded long-term executive leadership to oversee regulatory, clinical, and quality functions, and placed seasoned talent to lead the day-to-day internal and external clinical activities, including support for marketing, product management, and R&D. They are extremely knowledgeable about all aspects of the IVD landscape and provided essential guidance on strategy and execution. Work products were always of the highest quality and were delivered on time with an eye for detail and precision. Above all, the team was an absolute pleasure to work with and operated with the highest level of professionalism and integrity. Arete Biosciences is a valuable partner in the industry, consistently going above and beyond to meet and exceed expectations.”
Anthony Green
Former VP, Head of Commercial, Talis Biomedical Corporation
