Company Presentation. (sfi) 2 karrieredag. 31 October Knut T. Smerud Founder, Chairman and CEO SMERUD MEDICAL RESEARCH GROUP

Transkript

1 Company Presentation (sfi) 2 karrieredag 31 October 2012 Knut T. Smerud Founder, Chairman and CEO 1

2 2 AGENDA SMERUD CRO firmaprofil Hva gjør vi? Hvem er vi? Hvor er vi? Stillingstyper for statistikere Ledige stillinger

3 3 FASER I ET LEGEMIDDEL-UTVIKLINGSPROGRAM PRE-CLINICAL REGULATORY CLINICAL DEVELOPMENT RESEARCH REVIEW POST- MARKETING EVALUATION Synthesis Phase I Phase II Phase III Phase IIIb Phase IV Basic research Biological testing & pharmacological screening volunteers patients patients Exploratory development Commercialisation Regulatory development Time (yrs):

4 4 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

5 5 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

6 List of Services Clinical operations Biostatistics Data management Regulatory affairs Medical writing Consulting Training courses 6

7 Services Biostatistics Study design Sample size estimations Power analyses Randomization Analysis plans Statistical analysis and report 7

8 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 8

9 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 9

10 Hvem og hvor? Operations since 1993 Approx 75 employees 4 statistikere 2,6 årsverk Client base: Biotech Pharma Clinical academics Global HQ: Oslo (Norway) Subsidiary offices: Oslo (Norway) Copenhagen (Denmark) Uppsala (Sweden) Helsinki (Finland) Manchester (UK) Warsaw (Poland) St Petersburg (Russia) Budapest (Hungary) Vienna (Austria) 10

11 Statistikerens rolle hos SMERUD Ekspertrådgivning til tverrfaglig team Regulatory Affairs Drug manufacturing Legal & IP Non-Clinical Development Project Core Team Business & Marketing Clinical development Health Economics Statistics 11

12 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 12

13 Ansettelsesplan statistikere Ledig NÅ Timebetalt veiledning for Statinet-studenter % stilling for prosjektstatistiker Lengre sikt (0.5-3 år) Avdelingsdirektør Post doc Global consulting Markedsposisjonering synlig i markedet publikasjoner forskningsaktiv Personalledelse Resultatansvar 13

14 Takk for oppmerksomheten, velkommen til oss! Hovedkontoret: Drammensveien 41, Oslo Web Phone Mobile