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CDISC Presentation - aCROnordic Health Claim Services ApS
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 Proprietary Information of aCROnordic Health Claim Services ApS 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 Proprietary Information of aCROnordic Health Claim Services ApS 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 Proprietary Information of aCROnordic Health Claim Services 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 Proprietary Information of aCROnordic Health Claim Services ApS 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 Proprietary Information of aCROnordic Health Claim Services ApS 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 Proprietary Information of aCROnordic Research Clinic ApS 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 Proprietary Information of aCROnordic Research Clinic ApS Pièce de Résistance Competitive fixed-cost pricing Proprietary Information of aCROnordic Health Claim Services ApS 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 Proprietary Information of aCROnordic Health Claim Services ApS 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 Proprietary Information of aCROnordic Health Claim Services ApS 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
