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
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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)
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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
knut.smerud@smerud.com
Phone
+47 2327 2000
Mobile
+47 9089 2577
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