Data Analytics

Our global Data Anayltics group is a dedicated, experienced team of biostatistics, statistical programming, and data management professionals devoted to delivering individualized, adaptable, and dedicated services to support all of your data and analytical needs.
The key to excellent data management is flexibility. We respond to your needs by nimbly adjusting to change and striving to avoid timeline modifications.

Case report form (CRF) design, electronic or paper
Database set-up and validation
Electronic data capture (EDC) systems implementation and training
Double data entry for paper CRF–based studies
In-depth, thorough quality assessments, checking for errors or trends and querying data through final database lock
Validation of all system components throughout the study period as modifications are introduced
Adherence to benchmarks set by SCDM and CDISC

Work with us for full-trial build, or select from our suite of Data Management Services:

Use of familiar systems improves efficiency because it frees sites to focus on the protocol requirements rather than technology. We work with industry-leading technology partners substantiated by solid records in the field, allowing us to provide the right solutions for each trial and every sponsor. Our stellar data-management services—and therefore your study’s success—is based on these cloud-based Electronic Data Capture (EDC) systems:

At the end of the day, regulatory agencies speak the language of P-Values and Confidence Intervals. Fervor’s expert Biostatistics and Programming team will ensure the statistical analyses con-ducted in your study are not only correct, but also easily understandable. Fervor’s biostatisticians close the gap between statistical analysis results and understanding what they truly mean.

Our statisticians frequently collaborate and/or meet with regulators in various therapeutic divisions including standard and alternative regulatory paths such as orphan, breakthrough, and fast-track.

Sample size and power calculations
Randomization schedules, treatment kit lists, blind break documents, masking plans
Customized tables, figures, and listings for Phase I-IV clinical trials
CDISC database standardization and legacy conversions
Data integration and integrated summaries (ISS/ISE)
Interim analysis (futility, sample size re-estimation, efficacy, endpoint reviews) and safety updates
Supportive analyses for publications, manuscripts, scientific presentations, ab-stracts, etc.
Adaptive designs
Data monitoring committees
Biometrics leadership on timelines, handoffs, communication plans, and milestones across data vendors and all functional areas and vendors
Review of data management documents and database setup

Statistical Analysis

CDISC: SDTM and ADAM

Our team has CDISC expertise and can set up a CDISC strategy that fits corporate, financial, and regulatory goals. We have created CDISC SDTM and ADaM compliant datasets for over 60 studies and performed many CDISC compliant regulatory submissions.

Ongoing studies and historical databases/legacy conversions
Programming specifications for SDTM and ADaM
SDTM and ADaM domains (SAS datasets/transport files)
SDTM annotated CRF (acrf.pdf)
Define.xml files for SDTM and ADaM
Reviewer’s guides in multiple formats (e.g., PHUSE standard) including validation confirmation and OpenCDISC/Pinnacle 21 notes
Study program guides that provide details on how programs and macros are used to create the SDTM and ADaM domains

Our team has CDISC expertise and can set up a CDISC strategy that fits corporate, financial, and regulatory goals. We have created CDISC SDTM and ADaM compliant datasets for over 60 studies and performed many CDISC compliant regulatory submissions.

Strategic product development plans
Individual study protocol development including novel and complex trial designs
Adaptive trial designs
Real-world evidence and/or other external controls
Natural history studies
Patient registries
Exploratory analyses for corporate or scientific support
Sample size and power calculations
Regulatory submission strategies

Statistical consulting and development strategy

Data monitoring committee and Scientific Review Committees

Our industry recognized statisticians will advise and support you throughout the entire DMC process. We can guide sponsors in subject safety, potential risks, identifying indicators that warrant the trial to stop early due to futility or efficacy, sample size changes, and dropping treatment arms in multi-armed trials.

Statistical representation as either voting DMC member or as independent external statistician
Identify and recruit committee members
Prepare and/or review DMC charter and interim analysis plan
Prepare masking plans and maintain blinded and unblinded firewalls
Coordinate and manage organizational and data review meetings
Attend and/or lead meetings
Perform statistical analysis (blinded and/or unblinded)
QC prepare and distribute DMC data packages
Prepare open and closed session meeting minutes
Post-meeting follow-up and additional data requests