CDISC, SDTM, ADaM and submission-ready deliverables.
Praveg maps and programs CDISC-compliant SDTM and ADaM datasets, TLFs, Define.xml and reviewer's guides for regulatory submissions. It is for sponsors and CROs that need submission packages built and validated to the standards regulators expect.
Scope of work
SDTM and ADaM
Mapping specifications, dataset programming and conformance validation.
- Controlled terminology and versioning
- Pinnacle 21 conformance
- Traceability from CRF to analysis
TLF deliverables
Tables, listings and figures programmed to the SAP, with a tracked deliverables plan.
- TLF tracker and QC status
- Double programming where required
- Output review cycles
Define.xml and reviewer's guides
Define.xml, SDRG and ADRG prepared for submission.
- Define 2.x
- Study and analysis data reviewer's guides
- Submission package assembly
Standards governance
Sponsor-level CDISC standards, global libraries and change control.
- Standards library and governance
- Legacy data conversion
- Training for programmers and data managers
A good fit when
- Sponsors preparing a first regulatory submission
- CROs needing surge capacity for CDISC deliverables
- Organisations setting up CDISC standards governance
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
Can you convert legacy studies to CDISC?
Yes. Legacy data conversion to SDTM and ADaM, with Define.xml and reviewer's guides, is a standard engagement.
Do you validate with Pinnacle 21?
Yes. Conformance checks are run and findings dispositioned before any package is released.
Let’s accelerate together.
Reach out for a discovery conversation, no obligation, just clarity on where structure can unlock speed.