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Future direction:
CDISC - an integrated part of eCTD
May 2015
aCROnordic - CDISC Legacy Data Conversion Services
Are you prepared for the future?
FDA submissions will soon require CDISC formatted study data. According to new FDA Guidelines1 NDAs, ANDAs, BLA and
INDs must be in electronic format specified by FDA, and must
include CDISC formatted study data. The guidelines was approved December 2014 and will be effective 24+ months from
approval.
Study Data Standards for Regulatory Submissions Position Statement
Position Statement
FDA recognizes the investment made by sponsors
over the past decade to develop the expertise and
infrastructure to utilize Clinical Data Interchange
Standards Consortium (CDISC) standards for study
Ad 1: www.fda.gov/forindustry/DataStandards
data. The submission of standardized study data
enhances a reviewer’s ability to more fully under-
Implication of CDISC means:
stand and characterize the efficacy and safety of a
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The Prescription Drug User Fee Act (PDUFA V)
All submitted trial data must be submitted in CDISC format
All new studies must be captured in CDISC format
“Submissions not reviewable to FDA will not be filed unless
exempted”
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aCROnordic can help converting your
Legacy study data to CDISC
medical product.
Performance Goals state that FDA will develop guidance for industry on the use of CDISC data standards for the electronic submission of study data in
applications. In the near future, FDA will publish
guidance that will require study data in conformance
to CDISC standards.
FDA envisions a semantically interoperable and
sustainable submission environment that serves
both regulated clinical research and health care. To
Why aCROnordic ?
this end, FDA will continue to research and evaluate,
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Cost efficient, high quality
current and emerging data standards. FDA does not
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Fast delivery, fixed price
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Including medical/statistical reconciliation
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10+ years using CDISC
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CDISC member since 2004
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CDISC Registered Solution Provider
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GCP validated infrastructure
with its stakeholders, potential new approaches to
foresee the replacement of CDISC standards for
aCROnordic Health Claim Services ApS
study data and will not implement new approaches
without public input on the cost and utility of those
approaches.
September 13, 2013
About aCROnordic
aCROnordic is a virtual company operating globally with
local customer contact. We focuse on the clinical
documentation required for health claim products including:
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Pharmaceutical products
Medical devices
Food supplements
Cosmetics
Our services cover:
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Full Clinical Trial Services –Single Point of Contact
CDISC Legacy Data Conversion and consulting
Research Site Services and Support
All our services are supported by a unique cloud based
infrastructure with well proven QA System and Standard
Operating Procedures.
Contact Us
For more information about our services :
Web: www.aCROnordic.com
Mail: getCDISCnow@aCROnordic.com
aCROnordic Health Claim Services ApS
Copenhagen Bio Science Parrk
Ole Maaløes Vej 3
2200 Copenhagen N
Phone: +45 7199 4400
India:
Plot # 38, Phase - 1
Paigah Colony
Secunderabad, Hyderabad
Telangana 500003,India
Phone: +91 98853 74030
US Phone: +1 201 606 2282
Finder’s Fee
We believe that the best way of selling our services is through satisfied customers. Please share your experiences with us on our website. If your recommendations give us new customers, we will reward you with
a finders fee for the first contract. Please contact us as soon as possible with potential leads to ensure that
your are the lead holder qualified to receive our award.
aCROnordic Health Claim Services ApS