Business Need

Clinical Development can take years to complete, and can involve a large number of clinical trials. The preparation of submission to regulatory agencies requires aggregation of data from these trials in a consolidated and standardized form. The data the sponsor is in possession of would not be in a format that could be used for the presentation of the data to the regulatory agencies – and this requires data standardization and conversion.

Why Data Standardization?

This clinical submission process involves identifying which of the STDM datasets need to be produced, and generating the same for a submission – using the data available from multiple sources, in multiple formats. The challenge is even bigger when clinical studies are conducted over many years, and the sponsors have not followed CDISC standards while the studies were conducted, and such legacy studies need converting to SDTM to be part of a submission. This demands significant metadata logical mapping and programming, in addition to deep expertise in CDISC Standards and the understanding of clinical data.

There is significant business value that can be derived from an effective non-clinical data standards approach. SEND, or the Standard for Exchange of Nonclinical Data, is an implementation of the CDISC Standard Data Tabulation Model (SDTM) for nonclinical studies, which specifies a way to present nonclinical data in a consistent format. Standardized datasets are expected to support:

  • FDA’s efforts to develop a repository for all submitted study data
  • Suite of standard review tools to access, query, and view the tabulations

The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) released binding guidance on December 17, 2014 that sets requirements for the submission of SEND datasets.

How Can Navitas Help?

Navitas provides end to end data standards processing services that include Clinical Data Interchange Standards Consortium (CDISC)’s compliant Study data tabulation model (SDTM) and Analysis data model (ADaM) conversion activities such as annotation, mapping specification, programming, preparation of reviewers guide and define.XML. Navitas’ proprietary process and accelerators for CDISC, SDTM (Study Data Tabulation Model) conversion, increase the speed and efficiency of the drug development process for businesses in the Life Sciences vertical. They enable faster, efficient and reliable conversion of existing clinical trial data to CDISC SDTM domains that would be part of the Company’s New Drug Applications (NDA) submitted to the regulatory agencies such as the FDA and EMA, for their review and approval.

Offerings

Unlike ad-hoc approaches that make the standardization a tedious and time consuming task, fraught with potential data integrity and quality risks, Navitas’ proprietary process uses standard reusable metadata repositories, software tools, and a proprietary process (modularized approach) to automate the logical mapping and to generate the SDTM data sets. Our process also embeds best practices like – checklists for logical mapping, CRF annotation, verification of SDTM datasets, automated target exception report, and guideline documents for all the activities. The resulting package includes Converted SDTM Datasets, DEFINE package, SDTM annotated CRFs and a Reviewer’s guide.

  • Consulting for CDISC Standards
  • SDTM Conversion
  • ADaM Implementation
  • Sponsor Designed Standards Implementation
  • Governance Processes
  • All
  • AMS
  • BI
  • Brochure
  • CaseStudy
  • Clinical
  • CMS
  • MedicalDevices
  • On DemandWebinar
  • Quality
  • Regulatory
  • Safety
  • Technology
  • Whitepaper

Latest News

20
Apr2017

ICH Reflection on “GCP Renovation”: Modernization of ICH E8 and...

Navitas welcomes the opportunity to provide comments on this Reflection Paper... Navitas welcomes the opportunity...

13
Apr2017

Navitas Life Sciences Augments Global Executive Management Team

Navitas Life Sciences announced the appointment of Dr. Krishnan Rajagopalan as Chief Growth Officer....

24
Jan2017

Navitas Networks announce Forum dates for Spring, 2017

The Navitas Networks are pleased to confirm the dates for our upcoming Spring forums... ...

17
Jan2017

Navitas Launches Labeling Assessment Express

Regulators are changing the way they look at labeling. The emphasis is on ensuring...

02
Nov2016

BioVectra chooses pharmaREADY for eCTD Solution

BioVectra has chosen pharmaREADY for its eCTD requirements. BioVectra, located in Canada, manufactures...

05
Oct2016

Navitas at DIA's 10th Annual Forum for Qualified Persons...

Navitas Principal Jeffrey Ho will present "Efficient content management for the compilation and...

04
Oct2016

News 2016

[row id="1" class="ROW_CLASS"] [col class="span12"] 02 Nov 2016 AbbVie and Navitas Present Case Study on the Evolution...

27
Sep2016

Navitas releases paper on CDISC, the standards and why the...

The FDA (and eventually, regulatory agencies from around the world) will require clinical data...

13
Sep2016

AbbVie and Navitas Present Case Study on the Evolution and...

At 10:30a.m. (East Coast Time) on September 22nd, Navitas and AbbVie will...

29
Jul2016

Navitas Networks announce Forum dates for Autumn, 2016

The Navitas Networks are pleased to confirm the dates for our upcoming Autumn forums....

12
Jul2016

Navitas Celebrates 100th pharmaREADY customer

pharmaREADY is Navitas’ intuitive and easy to use, fully integrated, regulatory compliant, web-based suite...

28
Jun2016

Navitas' PVTech Summit Defines Future Success

Navitas’ PVTech Summit was held on June 15th at the Hudson Hotel in New...

18
May2016

Navitas Welcomes Tara Baer to Navitas

Navitas is pleased to welcome Tara Baer, who joins Navitas' Regulatory Practice. With over...

18
May2016

Navitas Speaks at Sparta Connection in Orlando

David Gwyn, Navitas' Technology Practice lead, will unveil idmpREADY at the Sparta Connection conference...

14
Mar2016

Navitas Earns Speaking Sessions at DIA’s 52nd Annual Meeting

In two different sessions, Subject Matter Experts from Navitas will address new challenges facing...

09
Mar2016

Navitas is pleased to announce the introduction of our networks...

Navitas' inaugural pvindia meeting took place in Mumbai on Thursday 03 March, 2016. ...

25
Jan2016

Navitas Announces the Inaugural pvindia Forum

Navitas will soon be adding to our portfolio of industry leading networks with the...

18
Jan2016

Navitas Relaunches pharmaREADY.com

pharmaREADY.com is Navitas' next generation website for its fully integrated, regulatory compliant document management,...

14
Dec2015

Steve Arlington, Navitas Advisor, Spoke on the Challenges, Opportunities and...

Steve Arlington, Navitas Advisor, Spoke on the Challenges, Opportunities and Future of the Pharmaceutical...

03
Nov2015

The changing trends in drivers of life sciences R D...

Outsourcing is not new in the life sciences sector. Clinical research outsourcing, contract sales...