The drive to value-based healthcare puts increasing pressure on medical device companies to innovate while delivering growth and profitability. With the premier technical expertise of Quartesian, we utilize advances in informatics and digitalization to help clients innovate and achieve operational excellence.

Veranex helps medical device companies innovate in a value-based healthcare environment, supporting market access, value communication, and solutions development, delivered through innovative business models that help innovators and their customers win in the following clinical areas:

Focus Areas

  • Cardiovascular
  • CNS | Neurology
  • Diabetes
  • Drug delivery | Combination products
  • Imaging | Visualization, all modalities
  • Inpatient monitoring
  • OB/GYN
  • Oncology
  • Ophthalmology
  • Orthopedics
  • Pulmonology
  • Remote monitoring | Home health
  • Surgical devices
  • Women’s health
  • Wound care

Well-Designed Studies Optimize Outcomes

We help our clients satisfy testing requirements for intended markets. We oversee both GLP and non-GLP animal studies for acute or chronic assessments as well as cadaver studies. We support study design and operations, managing first-in-human and early feasibility studies, pivotal trials for commercial approval, and post-market registries.

Clinical Services Include:

  • Case report forms
  • Clinical report
  • Informed consent
  • Investigator brochure
  • Protocol
  • Clinical events committee
  • reporting
  • Data safety monitoring board
  • Essential documents/central study files
  • Investigator meeting
  • Manual of operations
  • Monitoring plan/oversight
  • Reading center/core lab interface
  • SAE narratives/reporting
  • Study management
  • Clinical readiness of product
  • FDA early feasibility IDE opportunity
  • U.S. and/or OUS studies
  • Bioresearch monitoring (BIMO) inspections
  • cGMP support
  • Clinical audits of sponsor or CRO
  • Clinical SOPs
  • Literature search
  • Closeout
  • Identification/selection
  • IRB/EC submission
  • Initiation
  • Interim monitoring
  • Investigator agreements Qualification
  • Regulatory files
  • Study budgets
  • Training
  • First-in-human/feasibility study
  • Pivotal trial
  • Post-market study/registry

Expert Data Services

Biostatistics is at the core of every clinical study from design and protocol development to analysis and reporting. Get the right support for your trial — throughout the entire clinical development process — and ensure that the correct data is captured and prepared for analysis.

Our highly skilled team of biostatisticians provide biostatistical consulting and services for preclinical, clinical, registration phase, and post-marketing studies, including regulatory submission and agency meeting representation for accurate, accessible, and reproducible high-quality clinical data. We ensure biometrics operations are compliant and up to date across a variety of different regulations, including 21CFR, ICH GCP, US-FDA, UK/NICE SI, EU CTR, and more.

Are you looking to add capacity or new services? Veranex delivers top-notch, low-cost resources so you can win business and maintain margin. Are you looking for data support? Veranex augments your staff and expertise to keep your trial on track and under budget.

Veranex’s data management processes are 21 CFR Part 11 compliant and user-friendly — ideal for paper CRFs, EDC-based projects, and rescue studies. We start by deploying a data capture system, then build the study database, review and verify data, and format it for submission to regulatory authorities — with database lock on or before deadline — every time.

Manage constantly evolving regulatory protocols and submission guidelines with our experts. Get collaborative, affordable support for clinical, data management, and biostatistics groups — whether you need minimal support or a whole team. From protocol development to regulatory support to publishing, our expertly prepared reports comply with local and ICH guidelines.

Our experts support writing and regulatory services to ensure complete, compliant, and high-quality deliverables. Receive documents that have undergone rigorous scientific, statistical, editorial, and quality control review, compliant with FDA, EMA, and other regulatory requirements.

The key to a solid working relationship with your sites and CRO partners is ensuring proper management during all stages of a trial. Go beyond traditional reporting to recognize patterns and identify outliers easily with our Confero Visualization Technology.

Clinical and medical data visualizations enable you to see relationships and patterns in data — they supplement the tables and reports traditionally found in clinical trial management. Confero data visualization enables you to track connections between operations and overall trial performance. This solution integrates with your clinical applications to collect trial data and other relevant information in one place, formatting it into graphics, charts, and dashboards that clarify data insights. Aggregate thousands of variables from disparate systems, no matter the source.

Detect, assess, understand, and prevent adverse effects and other treatment-related problems — enhance patient care and safety with pharmacovigilance.

Monitor your project within a robust safety system, and ensure consistent communication with safety experts. Veranex’s expert resources work with your team to create a well-designed safety management plan (SMP) for tests related to medicine testing and usage.

Get scalable, global resources that mitigate costs without sacrificing quality. Our clinical functional service provider (FSP) model offers flexible services tailored to the unique needs of your trial and situation. When you have one last hurdle to clear for a successful program — high-quality data, in a submission-ready format — Veranex delivers.

How do we do it? Our certified experts have years of experience dealing in a number of different formats, from statistical programming to data management. And our industry-leading employee retention provides a consistent team that understands your systems, processes, and expectations.