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CDISC is an open, multidisciplinary, neutral, 501(c)(3) non-profit standards developing organization that has been working through productive, consensus-based collaborative teams, since its formation in 1997, to develop global standards and innovations to streamline medical research and ensure a link with health care. The CDISC mission is "to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare". The CDISC Vision is "informing patient care and safety through higher quality medical research". The CDISC suite of standards supports medical research of any type from protocol through analysis and reporting of results. They have been shown to decrease resources needed by 60% overall and 70–90% in the startup stages when they are implemented at the beginning of the research process.

They are harmonized through a model that is now not only a CDISC standard but also an HL7 standard on the path to becoming an ISO/CEN standard, thus giving the CDISC standards (harmonized together through BRIDG) international status and accreditation.

StatsMetrika - Bridging the gap to get CDISC approved.

 

First of all, What is CDISC?

CDISC is a global, non-profit standards developing organization that has been working through productive, consensus-based collective teams, since its formation in 1997, to develop global standards and innovations to design effective medical research and ensure a relationship with health care.

 

CDISC Vision For The Future

The CDISC vision is to inform patient care and safety through higher quality medical research.

Principles CDISC Proudly Sticks By.

  • To lead the development of standards that improve efficiency while supporting the scientific nature of clinical research.
  • Recognizing the ultimate goal of creating regulatory submissions that allow for flexibility in scientific content and are easily interpreted, understood, and navigated by regulatory reviewers.
  • Acknowledging the data content, structure and quality of the standard data models are of utmost importance
  • Maintaining a global, cross-functional composition for CDISC and its working groups.
  • Working with other professional groups to encourage that there is maximum sharing of information and minimum duplication of efforts.
  • To provide educational programs on CDISC standards, models, values and benefits.
  • Accomplishing the CDISC goals and mission without promoting any individual vendor or organization.

 

Perks of implementing CDISC standards include:

  • Advanced Efficiency
  • Enhanced Innovation
  • Facilitated Data Sharing
  • Increased Predictability
  • Complete Traceability
  • Improved Data Quality
  • Reduced Costs
  • Efficient Processe

 

Efficient Processe

As CDISC Registered Solutions Provider, StatsMetrika has a strong track record in providing CDISC solutions and as registered trainers in SDTM ( Study Data Tabulation Model ) and ADaM ( Analysis Data Model ), we provide professional expertise about requirements, processes, systems, as well as consultants, experienced in implementing these standards.

We have advised several major pharmaceutical companies all the way from first steps of implementing CDISC through to full implementation.

The United States Food and Drug Administration recommends using CDISC (SDTM) standards for electronic submissions of all clinical data, and requires agreement with CDISC standards for all new clinical studies starting after December 2016.

The European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency have also expressed intention to require CDISC.

 

CDISC [SDTM & ADaM] - Is This Standard Mandatory?

Regulatory authorities require data in standard format which is implemented over the globe. Clinical Data Interchange Standards Consortium (CDISC) has developed the various standards which include required standards Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM).

FDA has been already supporting and reviewing CDISC standards since long back.

FDA and PMDA has been already implemented CDISC standards and other regulatory authorities are also in process of the same. The data standards submission is becoming more important and challenging as FDA’s latest published guideline on December 2014 indicates that submission has to be done in CDISC standards for trials started after December 2016.

 

How Can StatsMetrika Help You ?

StatsMetrika has a strong track record in providing CDISC solutions and we are a CDISC Registered Solutions Provider.

We have converted more than 150 studies as part of ANDA submissions, most of which have been accepted by FDA and remaining are under review phase.

We have used our product development expertise to deliver productivity improvements with TMetrika , an in-house tool, used for mapping data to the SDTM format. The combination of efficient technology, and a global team of trained and experienced resources enables us to deliver high quality datasets at a cost saving of around 20% to 40% compared with traditional service providers.

We are CDISC solution providers of the following CDISC standards:
  • Analysis Data Model (ADaM)
  • Clinical Data Acquisition Standards Harmonization (CDASH)
  • Controlled Terminology
  • Define-XML
  • Standard for Exchange of Nonclinical Data (SEND)
  • Study Data Tabulation Model (SDTM)

StatsMetrika can successfully convert the unstructured data into standard format with our proprietary process and accelerators.

Our processes enable faster, efficient and reliable conversion of existing clinical trial data to standard domains that would be part of the submission to the regulatory authorities for their review and approval.