Pillar B · pharma · biotech · CRO · medical devices

Biometrics and life-sciences AI.

Praveg provides clinical data management, biostatistics and programming, CDISC and submission deliverables, vendor oversight and inspection readiness, and AI domain intelligence for pharma, biotech, CROs and medical device companies. It is for organisations that need senior clinical-data expertise delivered audit-ready and aligned to global standards.

·  CDM·  SDTM / ADaM / TLF·  Biostatistics·  CDISC·  21 CFR Part 11·  AI domain intelligence
What we deliver

Six ways we work with clinical data, statistics and technology leaders.

Clinical data management

eCRF design, edit checks, cleaning, coding, SAE reconciliation and database lock, audit-ready by design.

Learn more →

Biostatistics & programming

SAPs, sample size, interim and final analyses, SDTM, ADaM and TLF programming aligned to ICH E9.

Learn more →

CDISC & submissions

SDTM and ADaM mapping, TLFs, Define.xml, reviewer's guides and submission packages.

Learn more →

Vendor oversight & inspection readiness

Vendor oversight, data quality KPIs, audit and inspection readiness under GCP, GCDMP and Part 11.

Learn more →

CDM training

CDM Accelerate certificate, CDISC, EDC workshops, medical coding and regulatory compliance training.

Learn more →

AI domain intelligence

Requirement translation, GxP-aware AI guidance and business analysis for EDC, eCOA and clinical platforms.

Learn more →
End to end

From study start-up to database lock and submission.

1

Study start-up

  • Protocol review
  • eCRF design
  • Metadata build
  • Edit-check programming
2

Data collection

  • EDC configuration
  • UAT and site training
  • Query management
  • Data-entry oversight
3

Data cleaning

  • Medical coding
  • SAE reconciliation
  • Discrepancy resolution
  • Blind-review prep
4

CDISC standards

  • SDTM mapping
  • ADaM datasets
  • Define.xml
  • Reviewer's guide
5

DB lock & submit

  • Lock checklist
  • QC and audit trail
  • Final reconciliation
  • Regulatory package
ICH GCP E6(R3)ICH E9GCDMPCDISC SDTM / ADaM21 CFR Part 11Sponsor & CRO standards

AI inside Biometrics, not beside it. Praveg translates regulated clinical requirements into AI tool specifications, guides GxP-aware implementation with human oversight by design, and provides business analysis for EDC, eCOA and clinical platforms. AI domain intelligence →

Who we work with

Sponsors, CROs and the companies that build for them.

  • Pharma and biotech sponsors outsourcing or overseeing biometrics
  • CROs scaling data management, statistics and programming capacity
  • Medical device companies running clinical investigations
  • Clinical technology companies building EDC, eCOA and analytics products
  • Institutes and training providers in clinical research
Training

Practitioner-led CDM training.

CDM Accelerate certificateCDISC standardsEDC workshopsMedDRA / WHODrug codingICH GCP and Part 11

Industry-oriented programmes for graduates, institutes, CROs and EDC vendors. CDM training →

From the field

What the diagnostic finds in practice

Clinical researchP

Three teams, three versions of the same SOP, each believing theirs was current.

A contract research unit came to Praveg after a difficult inspection. The regulatory finding was about data integrity; the diagnostic found something more basic: no governance mechanism for SOP version control across sites, in an organisation that had grown from twelve people to ninety in four years. The gap was visible inside a week. A process governance board, a single SOP repository and a quarterly compliance review took eight weeks to implement. The next inspection outcome was materially different.

Chapter 1, Praveg OPTIC Maturity Model™ (First Edition 2026)
Clinical data managementOPTI

Passed not because the organisation was perfect, but because it could see itself clearly.

Six weeks before a sponsor quality audit, the assessment of a mid-sized CRO found a Data Management Lead role vacant for eleven weeks, a database lock checklist in two versions, an EDC system not revalidated after a protocol amendment, and query timelines tracked by study but not by site. The Priority Lens put Process first with Organisation worked to its enabling floor: the lead role filled on an interim basis in week one. The audit closed with four observations, none critical, and the sponsor's quality team noted the CRO's structured response to its own gaps as a positive indicator of quality culture.

Chapter 11, Praveg OPTIC Maturity Model™ (First Edition 2026)

Field vignettes are drawn from real engagements and have been anonymised, compressed and in places composited, as the book itself states. Figures are as reported by the people involved, not audited. They illustrate patterns; they are not case-study evidence.

What clients say

Trusted by sponsors, CROs and institutes

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.

FounderClinical Research Services Company

The guidance on EDC workflows, role structures, and governance models helped us avoid several costly mistakes during our platform planning phase.

Product LeadClinical Technology Startup

The training sessions bridged the gap between textbook knowledge and industry realities. Participants particularly appreciated the practical examples from live clinical-trial environments.

Training CoordinatorClinical Research Training Institute

The Clinical Data Management course content was industry-oriented and extremely relevant for freshers entering the field.

Student ParticipantIndia-based Leading CRO Training Programme
Questions people ask

Biometrics and life-sciences AI, answered

What biometrics services does Praveg provide?

Clinical data management, biostatistics and statistical programming, CDISC (SDTM, ADaM, TLFs, Define.xml) and submission packages, vendor oversight, data quality and inspection readiness, and CDM training, for pharma, biotech, CROs and medical device companies.

Is AI a separate practice?

No. AI domain intelligence and business analysis for pharma and biotech sit inside the Biometrics pillar: translating regulated clinical requirements into AI tool specifications, GxP-aware implementation guidance, BA for EDC, eCOA and clinical platforms, and practitioner tools.

Which standards and regulations do you work to?

ICH GCP E6(R3), ICH E9, GCDMP, CDISC SDTM and ADaM, 21 CFR Part 11, and sponsor or CRO SOPs where they apply.

Do you work with medical device companies?

Yes. Clinical data management, statistics and inspection readiness for device trials, and business analysis for device companies developing clinical data systems.

Can Praveg set up a biometrics function for a new CRO?

Yes. SOPs, QMS, role structures, training and the operating model, with the first studies run alongside the new team.

Let’s talk

Let’s accelerate together.

Reach out for a discovery conversation, no obligation, just clarity on where structure can unlock speed.

Book a call → Email info@pravegcs.com
Explore further
Inside BiometricsAI domain intelligencePillar APM & PMO Consulting