Loading

CDISC

Expertise.
  • 01

    Dedicated & experienced team Team of 30 professionals to provide CDASH & CDISC submission package Technical review team ensures accurate interpretation of SDTM / ADaM is applied in the package.

  • 02

    On-time: Whether it is a First-to-File, First-to-Market or a standard study, we commit to the timeline & meet it.

  • 03

    Delivers high quality & compliant services, cost-effectively

Services

Strategic Consulting
CDISC Standards Implementation
Standardizing legacy data models and Data conversion
Training of CDISC standards and Governance

Ongoing study data into CDISC compliant

CDASH Compliance
SDTM and ADaM
Open CDISC Validation (Pinnacle 21 validator)
Define.xml/ Define.pdf

CDISC Deliverables

SDTM
  • Domain XPTs
  • Reviewer
  • Annotated CRF
  • Define.xml
  • Define.pdf
  • CDISC validation report
ADaM
  • Input from biostatistician
  • Domain XPTs
  • Reviewer guide – ADRG
  • CDISC validation report
  • Define.xml
  • Define.pdf

Let’s Talk

Phone
+91 79661 35601
Address
17, Sigma I Corporates,
Opp. Mann Party Plot,
Off S.G. Highway, Bodakdev,
Ahmedabad - 380054.
Email
info@solvius.com