Company Presentation
(sfi)2 karrieredag 31 October 2012
Knut T. Smerud – Founder, Chairman and CEO SMERUD MEDICAL RESEARCH GROUP
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AGENDA • SMERUD CRO firmaprofil • Hva gjør vi? • Hvem er vi? • Hvor er vi?
• Stillingstyper for statistikere • Ledige stillinger
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FASER I ET LEGEMIDDEL-UTVIKLINGSPROGRAM PRE-CLINICAL RESEARCH
Basic research
CLINICAL DEVELOPMENT
Synthesis
Phase I
Phase II
Phase III
Biological testing & pharmacological screening
20 – 80 volunteers
100 – 1000 patients
1000 – 25000 patients
REGULATORY REVIEW
POSTMARKETING EVALUATION
Phase IIIb
Phase IV
Exploratory development
Commercialisation Regulatory development
Time (yrs): 0
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Stadier i én utprøvning Planning •Clinical rationale •Statistical plan •Protocol outline
Pre-study •Feasibility analysis •Identify investigators •Full protocol •Full data collection forms •Applications •Training / Ops Manual
During study •Patient selection •Patient recruitment •Patient treatment •Quality control (GCP) •Monitoring •Source data verification
Post-study •Data management •Statistical analysis •Study report •Publication of results •Conference (s) •Journal (s) •Investors •Media
time
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Kjernevirksomhet
CRO = contract research organisation • Kompetanse / Consulting Klinisk-regulatorisk strategi Medisinsk statistikk
• Kapasitet / Resourcing
Project management Clinical monitoring Data management Medical writing, Regulatory affairs & Quality Assurance
• Egen forskning Kliniske utprøvninger / samarbeid med akademia Statistisk metode anvendt i klinisk forskning
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List of Services • Clinical operations • Biostatistics
• Data management • Regulatory affairs • Medical writing
• Consulting • Training courses
SMERUD MEDICAL RESEARCH GROUP
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Services – Biostatistics • Study design • Sample size estimations
• Power analyses • Randomization • Analysis plans
• Statistical analysis and report
SMERUD MEDICAL RESEARCH GROUP
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Services – Consulting • Regulatory research • Regulatory strategy plan
• Clinical development plan • Direct Regulatory Authority interaction • Total contracting from phase II to market • External clinical and scientific advisors • Pro-active project proposals • Co-funding of clinical trials/programmes
SMERUD MEDICAL RESEARCH GROUP
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Smerud Statinet AS • Internett-basert kurs i medisinsk statistikk Innføring i statistikk, del I Innføring I statistikk, del II
Videregående statistikk • Varians- og regresjonsanalyse
Levetidsanalyse
• Typiske kursdeltagere: leger, biologer, farmasøyter
• Samarbeid med Legeforeningen / UiO Startet år 2000 m/ Petter Laake, Harald Fekjær
SMERUD MEDICAL RESEARCH GROUP
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Hvem og hvor? • Operations since 1993
• Global HQ:
• Approx 75 employees
• Subsidiary offices:
• 4 statistikere • 2,6 årsverk
• Client base: • Biotech • Pharma • Clinical academics
SMERUD MEDICAL RESEARCH GROUP
• Oslo (Norway) • • • • • • • • •
Oslo (Norway) Copenhagen (Denmark) Uppsala (Sweden) Helsinki (Finland) Manchester (UK) Warsaw (Poland) St Petersburg (Russia) Budapest (Hungary) Vienna (Austria)
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Statistikerens rolle hos SMERUD Ekspertrådgivning til tverrfaglig team
Regulatory Affairs
Drug manufacturing
Non-Clinical Development
Legal & IP Project Core Team
Clinical development
Business & Marketing Health Economics
SMERUD MEDICAL RESEARCH GROUP
Statistics
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Statistikerens rolle hos SMERUD Ansvarsområder og oppgaver
• Planning of clinical trials • Experimental design • Sample size estimations • Input to Case Record Form design
• Input to improve data quality in clinical trials
• Analyses of clinical trials • Statistical modelling
• Development of clinical trial analysis plans • Interpretation of data • Reporting of clinical trials Compiling statistical reports Co-author publications SMERUD MEDICAL RESEARCH GROUP
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Ansettelsesplan statistikere Ledig NÅ
Lengre sikt (0.5-3 år)
• Timebetalt veiledning for Statinet-studenter
• Avdelingsdirektør
• 50-100% stilling for prosjektstatistiker
• Post doc • Global consulting • Markedsposisjonering
‘synlig’ i markedet
publikasjoner
forskningsaktiv
• Personalledelse • Resultatansvar
SMERUD MEDICAL RESEARCH GROUP
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Takk for oppmerksomheten, velkommen til oss!
Hovedkontoret: Drammensveien 41, Oslo
SMERUD MEDICAL RESEARCH GROUP
Web
www.smerud.com
E-mail
[email protected]
Phone
+47 2327 2000
Mobile
+47 9089 2577
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