Biostatistics and statistical programming aligned to ICH E9.
Praveg provides biostatistics and statistical programming services: statistical analysis plans, sample size, interim and final analyses, and the SDTM, ADaM and TLF programming behind them. It is for sponsors and CROs that need senior statistical judgement and submission-grade programming on a flexible model.
Scope of work
Statistical analysis plans
SAP development aligned to ICH E9 and the estimand framework, with mock TLF shells.
- Protocol statistical sections
- SAP and TLF shells
- Randomisation specification
Analysis
Interim and final analyses, DMC support and statistical reporting.
- Sample size and power
- Interim analysis and DMC packages
- Clinical study report statistical sections
Statistical programming
SDTM and ADaM datasets, TLFs and validation programming with double programming where required.
- Dataset specifications
- TLF generation and QC
- Independent validation
Retrospective and real-world analyses
Survival and prognostic analyses on retrospective datasets, for investigators and publications.
- Analysis planning and costing
- Modelling and reporting
- Manuscript statistical support
A good fit when
- Sponsors without an in-house biostatistics function
- CROs needing senior statistical cover on specific studies
- Investigators with retrospective datasets to analyse
Senior, hands-on, accountable
Discovery call
A conversation about the real problem, not only the stated one.
Scoped proposal
Fixed scope, retainer or fractional model, with outcomes named.
Delivery alongside your team
Implementation, not only recommendations; adoption measured.
Handover and sustain
Capability transferred, lighter-touch support thereafter.
Trusted across industries
Praveg provided valuable strategic direction while helping us establish scalable biometrics processes. Their understanding of both operations and technology ecosystems significantly accelerated our setup activities.
The guidance on EDC workflows, role structures, and governance models helped us avoid several costly mistakes during our platform planning phase.
The training sessions bridged the gap between textbook knowledge and industry realities. Participants particularly appreciated the practical examples from live clinical-trial environments.
The Clinical Data Management course content was industry-oriented and extremely relevant for freshers entering the field.
FAQ
Do you provide independent statistical review?
Yes. Praveg provides independent review of SAPs, analyses and submission datasets, and can act as an unblinded statistician for interim analyses.
Which standards do you follow?
ICH E9 and E9(R1), ICH GCP E6(R3), CDISC SDTM and ADaM, and sponsor or CRO SOPs where they apply.
Let’s accelerate together.
Reach out for a discovery conversation, no obligation, just clarity on where structure can unlock speed.