Veranex employs best-in-class clinical trial data & analytics services that are coordinated and comprehensive. Services are delivered through teams that are flexible, scalable, and responsive to varying client types and levels of need.

Our service capabilities range from statistical programming and biostatistics, clinical data management, risk-based monitoring, and data visualization to medical writing/publishing, and pharmacovigilance, all of which help you build robust eCRF and better understand your data to maintain control of your clinical trial.

View trends, risks, and track performance with our data visualization tools, better understand adverse events through rigorous pharmacovigilance, and submit thorough, accurate reports to regulatory agencies with the help of our medical writing team.

Our range of services delivers the quality, expertise, and speed you need to advance your study with confidence. Get collaborative, affordable support for clinical data management, biostatistics and programming, RBM, medical writing, and pharmacovigilance groups — whether you need minimal support or a dedicated team.

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

Our Capabilities

Veranex_0104_PPTGraphics_051022_vF_biostatics

Biostatistics is at the core of every clinical study, from design and protocol development to analysis and reporting. Our highly skilled team of biostatisticians provides biostatistical consulting and services for preclinical and early phase studies to regulatory submissions and postmarketing activities for drugs, biologics, and devices. We are experienced in handling innovative designs, including adaptive methods, Bayesian techniques, basket trials, simulations, seamless trials, umbrella trials, and RWE. Our experienced consultants are available for agency meeting representation.

Statistical programmers at Veranex work closely with our statisticians to ensure analysis and reporting is accurate and adheres to study specifications and plans. Programmers have extensive CDISC experience with a range of therapeutic experience, including oncology, CNS, and cardiovascular indications. We select and/or recruit the right-sized statistical programming team (from our staff of 250+ programmers) to meet study needs and to deliver study deliverables on time. Whether study needs are small or large, urgent or still in the planning phases, Veranex can provide an experienced team to do the job on a cost-effective basis.

We ensure biometrics operations are compliant and up to date across all applicable regulations, including 21CFR, ICH GCP, U.S./FDA, U.K./NICE SI, EU CTR, and more.

Statistical and Programming Services:

  • Provide study design expertise for protocol development
  • Protocol development and review, including statistical sections, sample size and power calculations, and randomization methodology
  • Randomization plan development review and implementation, with IVRS and IWRS support
  • Blinded/unblinded data review and analysis support
  • Statistical and programming support for data monitoring committees (DMC, DSMB)
  • Statistical analysis plan (SAP) and mock shell development
  • PK/PD analyses and modeling
  • Analysis of cardiac safety data (pilot and thorough QTc studies)
  • Development of data set (SDTMs, ADaMs, ADS) and TLF SAS programming and validation based on a statistical analysis plan (SAP)
  • Review and interpretation of tables, listings and figures for statistical study report and/or as input to a CSR
  • Exploratory analyses for publications, abstracts, and marketing including meta analyses
  • Support with regulatory reporting for DSUR, PSUR, and 120-day safety updates
  • CDISC conversion of legacy data
  • BIMO listings and other regulatory reports
Veranex_0104_PPTGraphics_051022_vF_Data_Managment

Data management activities have an essential part to play in clinical trials, especially as trials are becoming increasingly complex. The collection, integration, and validation of high-quality data from a growing array of data sources is an integral part of the clinical trial and supports the success of a trial.

We have 21 CFR Part 11-compliant data management processes which can be used for paper CRFs, EDC-based projects, and rescue studies. Our team of professional data managers has certification in a number of top EDC systems and can work with clients to determine the best fit.

Need a decentralized trial? Our use of technologies to facilitate data management activities using remote consent and other electronic source data as documentation can help. These capabilities can provide adaptable and accurate data capture while maintaining regulatory compliance.

Once we select a data capture system, we build the study database, code the data (AE, MH, CM), review and verify data, and format it for submission to regulatory authorities, successfully working to achieve database lock on or before deadline.

Close collaboration with other functional groups, such as statistics and programming, project management, client and site-based staff, functions to keep data management activities on track with stakeholders informed and involved.

An additional service from this collaboration may come in the form of central monitoring/risk-based monitoring where the process of reviewing aggregate data from the ongoing trial using analytics and visualizations to identify patterns/issues/risks in the data can be carried out.

Data Management Services and Capabilities:

  • Case report form (CRF) design/eCRF
  • CDASH library of templates for CDISC SDTM mapping
  • Database development and validation
  • EDC system selection, set up, and training
  • Training for User Acceptance Testing
  • IRT integration within EDC system for randomizations
  • Development of data management plan
  • Coding of AEs and MHs using MedDRA, coding of CMs using WHODD
  • Quality process for query/resolution/reconciliation
  • Technology for handling decentralized monitoring and electronic source data
  • Use of dashboard visualizations and available service for risk-based management analysis and reporting

Veranex’s risk based monitoring (RBM) services deliver business insight by applying structured problem solving to your data. This approach combines “Industry Standard Concepts” and “Technologies” to focus on three crucial areas:

  • Central monitoring core activities
  • Clinical monitor/remote CRA support
  • Web analytics training support

A chief tenet of RBM is to evaluate your data and identify “risks” using a remote, “centralized” process rather than sending monitors to all your study sites. These processes employ statistical analyses to identify data problems, issues with sites (e.g., potential training issues that show up in the data, or data integrity), trends (e.g., increasing protocol deviation rates), and to focus on the most meaningful measurements for a study.

There may still be a need for on-site monitoring with centrally monitored trials, but the use of technology can make this a more focused and efficient endeavor than the traditional 100% SDV monitoring. With information from the monitoring reports, on-site reviews can respond to identified issues in a targeted manner. For decentralized trials, where the need for patients to travel to specific study sites is reduced or eliminated, the use of technology for monitoring activities may also take the place of on-site visits for SDV.

Key Veranex Deliverables for On-Site and Remote Monitoring:

  • Real time review of “targeted” data for source data verification and review
  • 100% review of informed consent forms (ICFs) for all subjects screened for the study
  • Review of protocol deviations and violations
  • Train investigator site personnel to ensure understanding of the protocol and all protocol-required procedures
  • Resolution of monitoring queries at every visit when possible
  • Evaluate any IRB responses or questions to make sure they have been answered and/or followed up
  • Issuing queries where required into the platform
  • Follow-up meetings with investigator to discuss findings/observations

Web Analytics Training Support:
Success with new processes and technology relies on good training and support. Veranex supports your organization to ensure questions get answered quickly, your users gain confidence, and you get the best possible results.

  • Training & first layer of user support
  • Work as point of contact (POC) to provide support post training
  • Gather requirements (i.e., navigation issues, report downloads, etc.)

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

Data visualization track data relationships and patterns to aggregate data from an ongoing trial using analytics and graphs/charts/figures to:

  • Identify poorly performing investigational sites
  • Detect unusual patterns in patient- and site-level data
  • Predict potential issues
  • Mitigate areas of risk
  • Correct problems in the execution of a clinical trial

Veranex has developed a process flow to bring this information to our clients, as part of our risk based management service.

rbm department overview key process handled and process flow site patient and site data into edc ctms labs ivrs spotfire key risks and cm analytics central data review integrated site support monitoring analytics output to study team and cra monitoring insights report (mir) study insight report (sir) cra equals clinical research associate, kri equals key risk indicator
Veranex_0104_PPTGraphics_051022_vF_Medical_Writing

Manage constantly evolving regulatory protocols and submission guidelines with our medical writing experts.

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, always compliant with FDA, EMA, and other regulatory requirements.

Veranex medical writing has generated over 500 CSRs, protocols, IBs, ICFs, and safety narratives with experience in early to late phase studies and submissions for drugs and devices.

Medical Writing Services and Capabilities:

  • Initial document development of protocols, investigator brochures (IBs), informed consent forms (ICFs) to
  • Periodic regulatory reporting needs for development safety update report (DSUR) or periodic safety update report (PSUR), to
  • Submission documents such as clinical study reports (CSRs), safety narratives, and CTD Module 2 summaries for clinical and non-clinical sections of a submission
  • Submission publishing/eCTD document publishing for an electronic submission gateway dispatch
  • Report publishing using publishing tools and Documentum
  • Redaction services for data protection
  • Clinical trial registration and results posting on clinicaltrials.gov
  • Publication abstracts, manuscripts, and conference posters
  • Extensive experience in PK and clinical endpoint/bioequivalence studies
Veranex_0104_PPTGraphics_051022_vF_pharmacovigilance

Patients come first. Stay on top of safety with better surveillance.

Veranex can help you monitor your projects within a robust safety system and ensure consistent communication and pharmacovigilance writing with safety experts. Our team of 40+ experts works with your team to create a well-designed safety management plan (SMP) and prepare all applicable reports for drugs, biologics, and devices.

What differentiates us from other service providers is the insight and all-around expertise we bring to our company.

We have a significant presence in India and two decades of experience implementing industry leading platforms enabling biopharmaceutical companies to better tackle their PV needs. We provide efficiency at a competitive cost while maintaining the highest standard in terms of quality and compliance.

With our in-house tracking and visualization tools, we manage deliverables leveraging prioritization, quality, and compliance.

We are a global company with multinational strategic locations, providing regulatory expertise across global markets:      

  • USA, Europe, & India (Bangalore, Hyderabad, Chennai, and Kolkata)

Our services include clinical development through postmarketing studies, with a host of integrated service offerings:

  • Pharmacovigilance with clinical data management, medical writing and publishing, statistical programming and biostatics, data visualization, and functional sourcing

Our Pharmacovigilance/Device Vigilance Services Include:

  • Case processing (clinical and postmarketing)
  • Aggregate reports
  • Literature screening
  • Signal detection
  • QPPV services
  • Safety database hosting
  • All other documentational logistics
  • Global PV audits
Veranex_0104_PPTGraphics_051022_vF_Functional_Sourcing

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.

Veranex’s Successful FSP Model Is Based On:

  • Skilled resources trained on customer’s process
  • Multiple teams (based on therapeutic area expertise) tied together to a centralized governance structure delivers consistency across portfolio
  • Flexibility to provide around-the-clock coverage
  • Dedicated resources who become integrated with the customer’s teams, driving synergies and cost efficiencies
  • Continuous training programs ensure our resources are upskilled to meet the challenges of new technology and solutions
  • Metrics driven performance evaluation increases productivity, maintains quality, and reduces timelines
  • Robust capacity management models allow flexibility to ramp up and down as needed
  • Manage and maintain high retention rates by providing incentives and career progression

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.

Veranex data management, biostatistics, and statistical programming staff have delivered clinical data services for more than a 1,000 trials. Our FSP engagements have ranged from two to three resources to as many as 75.

Through effective governance using skilled resources, we develop a cost-effective and transparent relationship with our clients that consistently delivers on timelines and quality.