Biostatistics and statistical programming consultants
Statisticians and programmers who turn clinical data into submission-ready analysis.
The problem we solve
Analysis is on the critical path and usually understaffed.
Database lock arrives and the TLFs are due in four weeks. The one statistician who knows the SAP is on another study. Programming standards drift between vendors and the CDISC validation report is red.
Vakula supplies biostatisticians and SAS and R programmers who can join a running programme, plus managed programming teams for full SDTM/ADaM/TLF packages.
Tell us what you need
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What we do
Biostatistics capabilities
Statistical analysis plans
Design input, sample size and power, SAP authoring and shell development.
SDTM and ADaM programming
CDISC-compliant datasets with define.xml and Pinnacle 21 clean reports.
Tables, listings and figures
Production and QC programming for CSR and submission outputs.
Statistical consulting
Adaptive designs, interim analyses, DMC support and regulatory statistical questions.
Clinical data management
CRF design, EDC build, edit checks and database lock in partnership with our clinical team.
Submission support
Integrated summaries (ISS/ISE), analysis data reviewer guides and agency question responses.
How an engagement runs
What happens after you contact us
Intake call
A consultant who works in this function takes the brief: scope, systems, regulatory context, timeline and budget band. Same day where possible.
Proposal and people
Within a few business days you get a written scope or a shortlist of named consultants with availability and rates. No generic CVs.
Kick-off under a clear SOW
Deliverables, acceptance criteria, reporting cadence and escalation path are agreed in writing before work starts.
Delivery with oversight
A Vakula engagement lead stays accountable for quality and continuity, including cover if a consultant rolls off.
Questions
Before the first call
SAS or R?
Both. Most regulatory deliverables remain SAS-based; we also support R-based pipelines where the sponsor has validated them.
Do you provide independent QC programming?
Yes, including double programming for key efficacy and safety outputs.
Can one person cover statistics and programming?
For small studies sometimes; for submissions we recommend separating the roles for independence and throughput.
Offshore delivery?
Our India team provides additional programming capacity under US statistical oversight, where the client permits.
Related
Adjacent services
Start with one requirement.
Send us a role, a scope or a problem. We come back with a plan and a named consultant, not a sales deck.