Veranex employs best-in-class clinical data management and statistical analysis delivered 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 testing, 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.

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.