Clinical Biometrics & Data Services for Clinical Development
Specialized CRO support across biostatistics, statistical programming & CDISC, clinical data management and medical writing - from study planning through analysis, reporting and submission-ready delivery.
THE SPACE FOR DATA ANALYSIS
ABOUT TUNECT
Specialized biometrics support for clinical development
TUNECT is a specialized CRO focused on clinical biometrics. We support Sponsor and CRO teams with biostatistics, statistical programming & CDISC, clinical data management and medical writing through project-based and FSP delivery models.
Our cross-functional teams keep data, analysis and documentation connected from study planning through reporting and submission-ready delivery.
INTEGRATED DELIVERY
One biometrics partner across the study lifecycle
Bring biostatistics, statistical programming & CDISC, clinical data management and medical writing into one coordinated delivery model. TUNECT can support an individual workstream or combine functions around a single study or development program.
– Study design and statistical strategy
– Sample size calculation and justification
– Endpoint and estimand strategy
– Randomization strategy and specifications
– Statistical Analysis Plan (SAP) development
– Statistical methods, sensitivity analyses and missing-data strategy
– TFL shell and output specification development
– Statistical interpretation and support for clinical reporting
– SAS and R statistical programming
– Randomization schedule implementation based on approved specifications
– SDTM mapping, programming and annotated CRFs
– ADaM specifications and dataset development
– TFL programming and independent QC
– CDISC validation and conformance checks
– define.xml development
– SDRG and ADRG development
– Submission-ready dataset package support
– Clinical study protocols and amendments
– Clinical Study Reports (CSRs)
– Clinical development and regulatory documentation
– Scientific literature review and evidence synthesis
– Study rationale and endpoint documentation
– Manuscripts, abstracts and conference materials
– Cross-document consistency and quality review
– Data Management Plan development
– CRF/eCRF design and EDC build
– Edit-check specification and implementation
– Data review, cleaning and query management
– Medical coding
– SAE and external-data reconciliation
– Data transfer and vendor-data integration
– Database lock readiness and database lock
– Data archiving and close-out support
Scale your clinical development team with experienced specialists matched to your project, therapeutic area, study phase and delivery needs.
TUNECT provides flexible FSP and dedicated-team support across:
– Statistical Programming
– Biostatistics
– Clinical Data Management
– Medical Writing
Individual specialists or dedicated functional teams can be embedded within Sponsor or CRO workflows and scaled as project needs evolve.
Study design and statistical strategy
Sample size calculation and justification
Endpoint and estimand strategy
Randomization strategy and specifications
Statistical Analysis Plan (SAP) development
Statistical methods, sensitivity analyses and missing-data strategy
TFL shell and output specification development
Statistical interpretation and support for clinical reporting
SAS and R statistical programming
Randomization schedule implementation based on approved specifications
SDTM mapping, programming and annotated CRFs
ADaM specifications and dataset development
TFL programming and independent QC
CDISC validation and conformance checks
define.xml development
SDRG and ADRG development
Submission-ready dataset package support
Clinical study protocols and amendments
Clinical Study Reports (CSRs)
Clinical development and regulatory documentation
Scientific literature review and evidence synthesis
Study rationale and endpoint documentation
Manuscripts, abstracts and conference materials
Cross-document consistency and quality review
Data Management Plan development
CRF/eCRF design and EDC build
Edit-check specification and implementation
Data review, cleaning and query management
Medical coding
SAE and external-data reconciliation
Data transfer and vendor-data integration
Database lock readiness and database lock
Data archiving and close-out support
Scale your clinical development team with experienced specialists matched to your project, therapeutic area, study phase and delivery needs.
TUNECT provides flexible FSP and dedicated-team support across:
– Statistical Programming
– Biostatistics
– Clinical Data Management
– Medical Writing
Individual specialists or dedicated functional teams can be embedded within Sponsor or CRO workflows and scaled as project needs evolve.
COLLABORATION
Designed to work within your clinical ecosystem
We collaborate with Sponsor teams, CRO partners, laboratories and specialist vendors, adapting to established systems, standards and governance.
Our role can focus on a single deliverable or extend across a broader clinical development program, with clear ownership and cross-functional coordination.
HOW WE WORK
Clear ownership, reproducible workflows and independent QC
TUNECT teams work from agreed specifications, documented processes and traceable review cycles. Statistical, programming, data-management and writing activities stay connected so that changes are carried consistently into datasets, analyses and documents.
We integrate with existing Sponsor or CRO standards and systems rather than introduce an unnecessary parallel process.
