Veranex delivers best-in-class clinical data management and statistical analysis through teams that are flexible, scalable, and responsive to varying client types and levels of need.

Our data management capabilities extend from statistical programming and biostatistics, medical writing and publishing to data visualization and medical device safety, which help you better understand your data to maintain control of your clinical trial. Our clinical data services deliver the quality, expertise, and speed you need to advance your study with confidence. 

For Data Management To Maintain Control Of Your Study, Veranex Is Your Difference

Our Capabilities

Biostatistics is at the core of every clinical study, from design and protocol development to analysis and reporting. Get the accurate, reproducible data you need throughout the entire clinical development process with Veranex.

Our highly skilled team of biostatisticians provides biostatistical consulting and services for medical device evaluation, clinical, registration phase, and postmarketing studies, including regulatory submission and agency meeting representation. We ensure biometrics operations are compliant and up to date across all applicable regulations, including 21CFR, ICH GCP, US-FDA, UK/NICE SI, EU CTR, and more.

Services:

  • Provide statistical study design expertise for defining the study
  • Protocol development and review: including statistical sections, sample size,  power calculations, and randomization methodology
  • Randomization plan development, schedule generation, review and implementation, IVRS and IWRS support
  • Blinded/unblinded data review and analysis support
  • Statistical analysis plan development and mock shells creation with adaptable approaches
  • PK and PK/PD analyses and modeling
  • Analysis of cardiac safety data (pilot and thorough QTc studies)
  • Support and provide consultancy for data and safety monitoring board (DSMB), DMC, and interim analysis
  • TLFs review and interpretation of results
  • Exploratory analyses for publications, abstracts, and marketing, including meta-analysis

Our 21 CFR Part 11-compliant data management processes suit paper CRFs, EDC-based projects, and rescue studies. We deploy a data capture system, 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 medical writing experts. Get collaborative, affordable support for clinical, data management, and biostatistics groups — whether you need minimal support or a dedicated team. From protocol development and informed consent to regulatory support and publishing, we deliver accurate, clearly written documents prepared by experienced medical writers.

All documents go through rigorous scientific, statistical, editorial, and quality control review, and are always compliant with FDA, EMA, and other regulatory requirements.

Take your reports to the next level. Recognize patterns and identify outliers easily with our Confero Visualization Technology.

Clinical 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 lets you 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.

Monitor, understand, report, and prevent adverse events with pharmacovigilance from Veranex.

Monitor your project within a robust safety system and ensure consistent communication and pharmacovigilance writing with safety experts. Veranex experts work with your team to create a well-designed risk management plan (RMP) and prepare all applicable medical device reports.

Learn more about our Pharmacovigilance Services Here

Get scalable, global resources that mitigate costs without sacrificing quality. Our 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 many 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.

Since the FDA and EMA published regulatory guidance on risk-based monitoring (RBM) in 2013, the concept of Central Monitoring has become a technological enabler that makes clinical research more data-driven and more efficient than ever. To plan a Centralized Monitoring strategy, one should be familiar with the concept of risk management: identifying risks, estimating the potential impact, and creating mitigation plans. To do Central Monitoring, one needs to apply statistics to detect outliers or even detect possible scientific misconduct.

Veranex Risk Based Monitoring (RBM) services deliver business insight by applying structured problem solving to your data. This approach combines Industry Standard Concepts & Technologies to focus on three crucial areas:

  • Central Monitoring Core Activities
  • Clinical Monitor/ Remote CRA Support &
  • Web Analytics Training Support

Learn more about our Risk Based and Central Monitoring Services Here

Veeva CRO Partner Program for Clinical Data Management

Veeva Vault EDC enables an agile design approach for configuring casebooks that allows Veranex to collaborate effectively with sponsors during the build process and make changes to case report forms in real-time. This significantly reduces the time to build a study database so that data collection can start sooner. Veranex is also fully trained to build complex studies, migrate existing studies from different EDC platforms and make mid-study changes quickly in Vault EDC. Learn More.

Functional Service Provider Partner

With the creation of KPS in 2006, the founders envisioned a better alternative solution to traditional full-service outsourcing to CROs. One that would be customer-centric, nimble, and flexible. One that would provide only the most reliable and seasoned clinical professionals, and a full range of services and capabilities to help you in the specific way you need. In fact, KPS delivers peerless outsourced solutions across the spectrum of clinical trials: from Phase I through Phase IV. KPS Life maintains a far-reaching network of functional and therapeutic experts. Learn More.

Medrio Accelegro Partner Program

At Medrio, they know it takes a global village to achieve a healthier world. Since 2005, they’ve developed a successful ecosystem of visionary people who want to change the world – employees, customers, and partners alike. Their flexible eClinical suite consists of EDC, ePRO, eConsent, Direct Data Capture, and RTSM, and provides the most complete and accurate data in a traditional, hybrid, or virtual trial environment. We’ve supported sponsors, CROs, and sites from across the life sciences industry spectrum. Veranex has supported more than 300 studies using Medrio technology. Our expertise spans all therapeutic areas and phases of clinical trials. We aim to deliver the best customer experience possible because your success is our success. Learn More.

Medidata Accredited Partner

Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 1,900+ customers and partners access the world’s most trusted platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systèmes company (Euronext Paris: FR0014003TT8, DSY.PA), is headquartered in New York City and has offices around the world to meet the needs of its customers. Learn More.