Clinical Trials | Quality Assurance | Regulatory Compliance

Clinical, Quality & Regulatory

Accomplished clinical, quality, and regulatory professionals with extensive experience in the in vitro diagnostics and medical device industries

We offer broad and deep knowledge in all aspects of bringing innovative healthcare products to market from discovery through commercialization. With over 100 years of combined experience and an established track record of collaborating with clinical professionals, research scientists, and regulators, we have consistently demonstrated success in building clinical value and utility while also ensuring regulatory/quality compliance in diagnostics, combination products, and medical devices.

We provide expertise in:

Clinical Affairs

  • Creation of clinical study conduct operating procedures & templates

  • Clinical strategy, study design & protocol development for POC, OTC, moderate & high complexity in vitro diagnostic devices

  • Site identification, qualification & initiation

  • Contracts, budget negotiations & IRB submissions

  • Clinical monitoring plan generation

  • Oversight of informed consent recruitment & study monitoring

  • Clinical validation reports

  • ICH/GCP/BIMO Audits

Regulatory Affairs

  • Regulatory strategy & planning

  • FDA Submissions (Q-Submission, 510k – traditional, abbreviated & special, De Novo Classification Request, CLIA Waiver Application, Dual Submission) for OTC, POC, moderate & high complexity IVD & medical devices

  • Labeling review

Clinical Operations & Data Management

  • Electronic database development, build, verification, & deployment

  • eCRF build specification & user acceptance testing reports

  • Electronic informed consent (eConsent) capabilities

  • Clinical site set up & training material development

  • Data Management & Statistical Analysis plan & report generation

  • Case report form creation

  • Line data compilation

  • Procurement of clinical specimens to support feasibility to validation

  • Biorepository in Carlsbad, CA

Product Development

  • Guidance on assay development, verification, & validation strategies

  • Study design, protocol development, execution, & report creation for analytical verification activities

  • Creating design control deliverables, from design inputs to design transfer

  • Drafting manufacturing transfer documentation (BOMs, specifications, QC test methods & batch records)

  • Design & formatting Instructions for Use

Quality Management Systems & Compliance

  • Creation and implementation of ISO 13485:2016 & 21CFR820 fully compliant QMS

  • Quality system gap analysis, audits (ISO/FDA/MDSAP) & remediation

  • Risk Management File creation (ISO 14971:2019)

  • Document control support

  • eQMS selection, validation & implementation

  • Review of manufacturing records for compliance

Program Management

  • Lead cross-functional project core teams

  • Track and maintain project schedules & deliverables

  • Distribution of meeting minutes & action item follow up

  • Presentation to executive leadership of project status

Anthony Green - VP, Head of Commercial, Talis Biomedical Corporation

“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
VP, Head of Commercial, Talis Biomedical Corporation

Karen Menge, PhD.  Former Vice President & Chief Scientific Officer, ChromaCode, Inc.

“We partnered with Arete Biosciences for regulatory and clinical support for several 510k and EUA programs. We were an early-stage molecular diagnostics company with limited internal resources needing to move rapidly within the framework of meeting regulatory requirements. The Arete team delivered. They seamlessly integrated with the core teams and internal stakeholders and provided the expertise, flexibility, and resourcefulness critical to the success of the programs, particularly during the COVID-19 pandemic. Whether sourcing samples, constructing 510k pre-subs and EUA submissions, or supporting clinical operations, they did so with a sense of ownership, high quality, and a drive to succeed, no matter what curve balls we threw at them. In essence, they were a true part of the team, and a delight to work with.”

Karen Menge, PhD. 
Former Vice President & Chief Scientific Officer, ChromaCode, Inc.

Paul A. Granato, PhD, D(ABMM)Director of Microbiology / Scientific Director, Clinical Microbiology, Laboratory Alliance of Central New York

“Working with Arete Biosciences has been an exceptional experience for our research team. Their unwavering commitment to scientific rigor, coupled with their responsive communication and deep understanding of clinical research objectives, has made them an excellent partner. Arete Biosciences consistently provides the tools our research team needs to deliver results that exceed the Sponsor's expectations and contribute to the success of our collaborative projects. I have worked with the Arete clinical team for over 8 years, including companies prior to Arete Biosciences, and I have full confidence in recommending their services to any Sponsor seeking a collaborative, efficient, and results-driven Contract Research Organization.”

Paul A. Granato, PhD, D(ABMM)
Director of Microbiology / Scientific Director, Clinical Microbiology, Laboratory Alliance of Central New York

Why Arete?
Ask Yourselves This:

  1. Do you have a clinical and regulatory strategy?

  2. Where will you conduct your clinical trial?

  3. Do you have a robust and compliant quality management system?