1. No category

Legacy data conversion
We are embedded in CDISC colors and we intend to spread it to the World!
Proprietary Information of aCROnordic Health Claim Services ApS
About Founder
Søren Strøh
Master of Science in Electric Engineering 1979
Software developer - Medical Diagnostic equipment - from 1979 to 1986
Novo Nordisk 1985-1996 – Director since 1989
Diploma in Drug and Device Development – 1996
Personal competences
15 years as CEO for up to 60+ employees
Deep technical knowledge within
● Clinical Data Management
● CDISC Standardization and
● Life Science IT solutions
Personal relations
Well established network within Biotech and Pharma
Business relations
15 years as partner with Oracle HSGBU and SAS Institute
CDISC Registered Solution Provider, Advisory Board Member, member since 2004
Proprietary Information of aCROnordic Health Claim Services ApS
Partner
Jinesh Shah
Master of Science in Biostatistics and Epidemiology from Georgetown University – 2010
SAS certified base programmer – 2010
Biostatistician – Henry Jackson Foundation and Statistics Collaborative – 2011
Consulting statistician for Big Pharma – 2013
Personal competencies
4+ years of Statistical consulting experience in the industry – USA
Expertise in
●
●
●
●
Statistical consulting
Project management
Clinical data management and
CDISC Standardization
Personal relations
Well established network within Biotech and Pharma
Business relations
Member of American Statistical Association and Society for Clinical Trials
Active contributor and participant of Biostatistics and CDISC related Meetup groups
Proprietary Information of aCROnordic Health Claim Services ApS
The beginning …
The foundation to every
solution lies in the problem
Proprietary Information of aCROnordic Health Claim Services ApS
Past issue:
non-standard data
FDA received massive amounts of data for review
The data were in very disparate formats – using various
proprietary standards without following consistent rules
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Non-standard
data examples
Subject
Gender
DOB
Subjid
Sex
Date
11001
Male
1/9/1967
001
1
9JAN1967
11002
Female
5/6/1967
002
2
6MAY1967
11003
Female
2/8/1971
003
2
8FEB1971
11004
Male
3/1/1956
004
1
1MAR1956
PID
M/F
BDate
Usubjid
Gender
DOB
A100
M
1-9-1967
PS1001
M
1/9/67
A101
F
5-6-1967
PS1002
F
5/6/67
A102
F
2-8-1971
PS1003
F
2/8/71
A103
M
3-1-1956
PS1004
M
3/1/56
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Simple solution:
standardization
FDA and CDISC developed a set of data standards and
electronic (eCTD) submission guidelines
FDA developed – JANUS a hub for integrating data within
the FDA to support regulatory decisions
JANUS accepts CDISC SDTM as input
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ApS
CDISC:
What, why and when
What
CDISC study data as integrated part of eCTD submission
● FDA Guideli
ne - Submission Under Section 745A
● FDA Guideline - Standadized Study Data
Why
To optimize review
process
Fulfilment of PDUFA
benchmark KPIs
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When
Approved December 2014
● Standardization plan from start
● 2 years of initial run-in period
● 1 year of notice on updates
Current challenge:
CDISC legacy data conversion
Many pharma/biotech companies have not yet adopted
prospective use of CDISC data standards
Substantial amount of investment in infrastructure and expertise
Change in proprietary working procedure, data standards,
programs, reports etc.
Massive amounts of completed and ongoing studies to
be converted into CDISC
eCTD submission using CDISC data is approaching
soon
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Optimal problem solving …
Providing a simple solution
to an extraordinary problem
Proprietary Information of aCROnordic Health Claim Services ApS
aCROnordic
CDISC registered solutions provider
“We provide a simple solution to an
industry renowned problem:
CDISC legacy data conversion”
Proprietary Information of aCROnordic Health Claim Services ApS
aCROnordic
CDISC registered solutions provider
Simple business process
Highly efficient infrastructure tools
Pièce de Résistance
Proprietary Information of aCROnordic Health Claim Services
ApS
Simple business process
Client provides
aCROnordic
provides
Client receives
Study protocols
World class
infrastructure
High quality CDISC
compliant SDTM data
Annotated CRFs
Lean conversion
processes
Metadata define.xml
Legacy study data
Experienced local
/global resources
CDISC validation report
SAP, if applicable
Double layer
QC/validation
Brief medical/statistical
conversion report
Study Reports
Cost efficient services
Exploratory
medical/statistical
evaluation as add-on
service
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Highly efficient infrastructure tools
Global platform system
GCP validated
data & metadata
repository
CDISC compliant
medical/statistical
evaluation tool
CDISC validator
High proficiency mapping tools
Powerful validation and QC System
QC regulated programs for define.xml and statistical reports
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Pièce de Résistance
Competitive fixed-cost pricing
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How do we keep costs low?
Highly efficient Infrastructure tools
Increases productivity, cuts-down tiring repetitive work
and provides high confidence validation capabilities
Simple business process
We have narrowed it down to clear input and output
deliverables – thus saving time and money
Expert workforce
Our global and local resources are very proficient in their
respective fields
We use external consultants with specific therapeutical
expertise for medical/statistical review and exploration
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Why choose aCROnordic?
Our commitment to provide high quality results to the
client and to the medical community at large – is our true
motivation
We are CDISC registered solution providers who yield
outstanding services on a low-cost fixed charge basis –
without any compromise in quality, efficiency and
accuracy
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Contact Information
aCROnordic Health Claim Services ApS
Denmark (Headquarter)
India
Copenhagen Bio Science Park
Ole Maaløes Vej 3
DK- 2200 Copenhagen N
Denmark
Plot # 38, Phase - 1
Paigah Colony
Secunderabad, Hyderabad
Telangana 500003,India
Phone: +45 7199 4400
Phone: +91 98853 74030
US Phone
E-mail:
Web:
Proprietary Information of aCROnordic Health Claim Services ApS
+1 201 606 2282
[email protected]
www.aCROnordic.com