Advanced Clinical Research Technology

Advanced Technological Capabilities for Clinical Research

Since client budgets and objectives vary, our information technology capabilities are designed with scalability. This allows iuvo to provide options that meet the specific clinical data and information processing needs of our clients.

Our eCDM applications feature industry-proven software to facilitate acceleration of clinical trials with proven software for study design, data capture, and data management. It allows clinical database design to be performed rapidly and query development/validation delivered in real time.

Clinical data entry can be done in a controlled, timely manner. Data monitoring and query generation/resolution can be completed in advance of site monitoring visits. What’s best, assigned users have 24/7 data access and review throughout the duration of a clinical trial.

We enhance study administration with the availability of secure, study-specific, collaborative web portals for email, documents, data extracts, study metrics, and news items.

iuvo’s expert systems analysts provide programming support in compliance with 21 CFR Part 11 for seamless collection, storage, and extraction of clinical study data and information.

There are so many reason to perform clinical research — preliminary evaluation of safety (first in human, dose escalation, etc.), assessments of efficacy (comparisons of dosage levels, comparisons vs. gold standard, etc.), or performance/user preference comparisons versus alternative products or treatments. Regardless of your objectives, access to statistical expertise is critical to running a successful trial that will yield the best data, and, ultimately, meet your study goals.

iuvo’s clinical statisticians and programmers have experience with trial design and data analysis across a broad range of medical specialties and therapeutic areas. iuvo can provide statistical and clinical programming support for each stage of the clinical study process — before, during, and post-study They carry extensive knowledge of and experience in various types of trials, including: preliminary, early-phase studies; pivotal studies for regulatory submissions; and post-approval/marketing studies.

Careful planning in the design phase will not only ensure that the data collected can be used to evaluate the study hypotheses, it can also increase efficiency and decrease costs. During the pre-study stage, we offer our clients:

  • Input on clinical study design: a statistical perspective as to the appropriate models for study design and objective study endpoints
  • Sample size and power analysis: Determining the number of clinical study subjects necessary to appropriately and effectively evaluate study hypotheses
  • Protocol development: This is a particular expertise of iuvo. We will collaborate  with the clinical team and sponsors to develop the statistical sections of the protocol to ensure that study endpoints are appropriately collected for the analysis of study objectives
  • Randomization schedule development: This can help minimize any study enrollment bias
  • CRF Review: It is critical that the data is captured in an appropriate manner considering planned safety and efficacy analyses. Careful review by Biostatistics and Clinical Programming will also ensure that data is captured efficiently, resulting in a quick turnaround from data entry to analysis results incurring as few queries and data clarifications as possible.

Once a trial has begun, the Biostatistics and Clinical Programming Team can provide a variety of services so that valuable inferences can be drawn from the data at the conclusion of the study.

We also work with the Data Management team to conduct a careful, ongoing review of data as it becomes available to create a smooth transition to database lock and the generation of tables, listings and graphs.

To assist in the analysis of the data, we offer: 

  • Statistical methodology consultation: Determining the appropriate statistical tests, providing input on the types of tables and graphs best suited for summarizing the study endpoints, re-evaluating study assumptions, and making appropriate modifications to the analysis as necessary.
  • Statistical analysis plan (SAP) development: Providing pre-specification and documentation of the planned analyses in a comprehensive SAP in order to maintain the validity of statistical results. The SAP typically includes operational definitions of endpoints to be analyzed, rules for data handling and for inclusion into the various analysis populations (intent-to-treat, per protocol, safety, etc.), description of statistical methodology, identification and presentation of shells for planned statistical tables, figures and listings.
  • Analysis dataset specifications: Developing specifications for the analysis datasets to document the algorithm used in creating analysis variables
  • Interim statistical analyses: Performing pre-specified interim analyses for regulatory bodies, safety monitoring boards or as otherwise requested by the sponsor

We also work with the Data Management Team to conduct a careful, ongoing review of data as it becomes available to create a smooth transition to database lock and the generation of tables, listings and graphs. To assist in the review of incoming data, we offer.

  • Customized data listings: Enabling independent parties to conduct blinded or un-blinded safety reviews or facilitating the Sponsor’s data cleaning processes

After the clinical data has been entered and cleaned, the Biostatistics and Clinical Programming Team work together to determine whether or not the study’s objectives have been met.

At the conclusion of the study, we provide the following:

  • Final statistical tables, listings and figures: Generating tables, listings and figures from the locked database in a format that can be easily incorporated into a final report or presentation
  • Review and interpretation of statistical results: Interpreting statistical results to facilitate the understanding of the data analysis and provide guidance to medical writers on the implications of the statistical results
  • Ad-hoc exploratory analyses: Providing additional analysis of the data as indicated by the initial study results

In addition to the services we provide for formal clinical studies, iuvo’s Biostatistics and Clinical Programming Team offer assistance for:

  • Scientific presentations/journal articles: Providing statistical consultation and clinical programming support for scientific abstracts, presentations or articles submitted to conferences or publications
  • QC of tables and analysis datasets: Providing an independent accuracy check of Program Sponsor’s tables and analysis datasets based on the SAP and analysis dataset specifications

iuvo’s quality control procedures for statistical output involve a combination of independent programming and internal review to verify accuracy and completeness of tables, figures, and listings.