Clinical Development & OperationsBiometrics, Clinical Data & Statistical Sciences

CDISC, Submission Data & TLFs

Compare vendors for cdisc, submission data & tlfs within Biometrics, Clinical Data & Statistical Sciences, covering Clinical Data Standards & CDISC Consulting, SDTM Dataset Programming, ADaM Dataset Programming, Tables, Listings & Figures (TLFs)….

Capabilities in this workflow

Vendors supporting this workflow

Veristat is a specialty CRO providing biostatistics, clinical data management, and regulatory strategy and writing services.

Products: InStat, CoAuthor

Evidence-backed workflow match
Matches ADaM Dataset Programming
“Development of Analysis Data Model (ADaM) datasets in accordance with applicable standards and controlled terminology”
Source: veristat.com

Also offers: Biostatistics & Statistical Programming, Full-Service Clinical Trial Execution (CRO Services), +3 more

Saama is a life-sciences software and services provider offering biostatistics, clinical data management, data integration and AI-enabled analytics.

Products: Smart Data Quality, Smart Medical Coding +7 more

Evidence-backed workflow match
Matches ADaM Dataset Programming
“One place for all the statistical programming activities, program and dataset creation validation, to submission artifact development; all supported by integrated workflows, code…”
Source: saama.com

Also offers: Clinical Data Management, Data Integration, ETL & Interoperability, +1 more

Frontage Laboratories is a CRO and CDMO providing bioanalysis, DMPK and ADME studies, toxicology, Phase I support, and drug manufacturing.
Evidence-backed workflow match
Matches ADaM Dataset Programming
“Statistical analysis and programming support for data queries, database edit checks, and creation of analysis datasets”
Source: frontagelab.com

Also offers: Bioanalysis & Biomarker Assay Services, Integrated CDMO/CMO Services, +3 more

Celerion is a CRO and laboratory services provider supporting clinical development, bioanalysis, biometrics, trial operations, and regulatory submissions.

Products: ClinQuick

Evidence-backed workflow match
Matches ADaM Dataset Programming
“…Leveraging this involvement, Celerion delivers top-quality, SDTM- and ADaM-compliant data packages that meet regulatory requirements for submissions across a wide range of…”
Source: celerion.com

Also offers: First-in-Human (Phase I) Clinical Pharmacology Support, Clinical Trial Bioanalytical & Biomarker Testing, +2 more

Althian Clinical Research is a boutique CRO supporting clinical trials, regulatory submissions, safety, data, and real-world studies in Mexico and LATAM.
Evidence-backed workflow match
Matches Tables, Listings & Figures (TLFs)
“Our biostatistics team develops the statistical analysis plan, performs all required analyses, and generates tables, listings, and figures (TLFs) for inclusion in your clinical…”
Source: althian.com

Also offers: Full-Service Clinical Trial Execution (CRO Services), Marketing Authorization & Lifecycle Submission Support, +3 more

Inotiv is a CRO and research models provider offering toxicology, in vivo pharmacology, research and transgenic models, bioanalysis and DMPK.

Products: Teklad, Target Sufficiency +1 more

Evidence-backed workflow match
Matches Submission Dataset Preparation & Define.xml
“Inotiv’s expert team delivers CDISC compliant regulatory submissions SEND packages, transforming your nonclinical study data into structured, submission-ready formats.”
Source: inotiv.com

Also offers: Toxicology Studies, In Vivo Pharmacology & Efficacy Models, +3 more

Altasciences is an early phase CRO and CDMO providing toxicology, IND-enabling studies, clinical pharmacology, bioanalysis, and drug manufacturing.

Products: Acceleration Platform

Evidence-backed workflow match
Matches SDTM Dataset Programming
“Produce Clinical Data Interchange Standards Consortium (CDISC)-compliant datasets (SDTM, ADaM)”
Source: altasciences.com

Also offers: Toxicology Studies, First-in-Human (Phase I) Clinical Pharmacology Support, +2 more

Castor provides cloud-native software and services for clinical data capture, eConsent, eCOA, and data management, in trials and real-world evidence studies.

Products: Castor EDC, Castor CDMS +2 more

Evidence-backed workflow match
Matches Submission Dataset Preparation & Define.xml
“Export packages formatted for FDA eSub, EMA, and PMDA submission requirements. Define.xml generation and dataset validation are part of the standard export workflow.”
Source: castoredc.com

Also offers: Electronic Data Capture (EDC), eConsent, +2 more

ZS is a life-sciences consulting, technology and data firm providing commercial strategy, market access, medical affairs and clinical planning services.

Products: ZAIDYN, ZS Trials.ai +3 more

Evidence-backed workflow match
Matches Clinical Data Standards & CDISC Consulting
“Accelerate clinical data flow through standards-first governance and AI-enabled automation, helping teams speed analysis and improve submission readiness.”
Source: zs.com

Also offers: Segmentation, Targeting & Call Planning, Medical Insights Management, +6 more