ACM Presentation 2014

8/17/2019 ACM Presentation 2014

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Partnering with Pharmaceutical Leaders

Active in Clinical Research


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Company Overview

DO IT RIGHT THE FIRST TI

• Berlin-based CRO

• Founded in 2004

• Founding eber o MEDIS RESE"RCH GRO#$• "udi%ed eber o B&M" e'&' (in asso)ia%ion *i%+ E#CROF,

sin)e 200

• S.e)ialis% or s%ud/ anageen% and oni%oring

• Clien% base in%erna%ional and regional bio%e)+s1 large

.+ara

• Full-seri)e in se%%ing u. and )ondu)%ing )lini)al %rials *i%+

our***'allied-)lini)al')o


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Academic Sourcing


• Close rela%ions+i. *i%+ a)adei) ins%i%u%ions %raining

)lini)al resear)+ .roessionals

(Beu%+ Ho)+s)+ule1 $are3el ")ade/1 Mibeg Ins%i%u%e,• $la)een%s or .ra)%i)al %raining and %+esis *or

• Earl/ re)rui%en% o %o.-o-%+eir-)lass u%ure .roessionals

• Ca.a)i%/ or sudden in)rease o e.lo/ees

• Hig+ s%a5 re%en%ion due %o s%rong rela%ionss+i.s *i%+

e.lo/ees

***'allied-)lini)al')o


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Company History



• 2004 ounding Mi)+ael Roe+l ounds "llied Clini)al

Manageen%'

• 2007 res%ru)%uring 89rg :orb (orerl/ C+ari%;,


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Quality Management: Computer Security


• "))ess-res%ri)%ed and >re-.ro%e)%ed a)ili%/

• Ba)-u. IT-S/s%es

• Mirrored serers in se.ara%e lo)a%ions• $ro%e)%ed and a))ess-)on%rolled serers

• Fire*all irus .ro%e)%ion

• eel-based a))ess rig+%s



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Study Management


• Oersig+% o s%ud/ )ondu)% and s%ud/ oni%oring

• Budge% anageen% and %ra)ing

• $riar/ )on%a)% or %+e s.onsor• Coordina%ion o %+e s%ud/ %ea

• Oersig+% o uali%/ and %ielines

• Ris assessen%

• &endor anageen%

• S%ud/ se%-u.



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Study Management


• TMF se%-u. and ain%enan)e

• Consul%ing on (e,CRF sele)%ion and design

• Si%e easibili%/ and si%e sele)%ion• Organia%ion J leading o ines%iga%or ee%ings

• Crea%ion o s%ud/ do)uen%s and s%ud/ s.e)i>) o.era%ion

guides

• On-si%e se%/ ("E J S"E J edi)al in)iden%s, anageen%

• Drug su..l/ and des%ru)%ion

• Clini)al s%ud/ re.or% and reie*



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Study Monitoring


• Full oni%oring-seri)e1 on-si%e and reo%e

• Ris-based oni%oring

• Si%e isi%s (sele)%ion1 ini%ia%ion1 in%eri1 )lose-ou%,• Sour)e da%a eri>)a%ion

• C+e) o s%ud/ lis%s and do)uen%s

• ISF se%-u. and ain%enan)e

• Training o si%e s%a5



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Study Monitoring


• Moni%oring )o.lian)e *i%+ ICH-GC$1 s%ud/ .ro%o)ol and

regula%or/

reuireen%s• "E J S"E anageen%

• Condu)% o in%eri anal/sis

• uer/ anageen%

• Ines%iga%ional .rodu)% a))oun%ing

• Moni%oring re.or%s and ollo*-u. le%%ers



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Study Documentation


• TMF se%-u. and ain%ena)e

• ISF se%-u. and ain%enan)e

• Consul%a%ion on (e,CRF sele)%ion and design• Design o s%ud/ do)uen%s (logs1 *ors+ee%s1 anuals1

guidelines1

• %ra)ing lis%s e%)',



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Proofreading and ranslation


• $rooreading and %ransla%ion o s%ud/ .ro%o)ols1 .a%ien% diaries1

.a%ien% inora%ion and inored )onsen% and o%+er e/

)lini)al %e3%s• Ka%ie Englis+ and Geran s.eaers



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!ull Service


MEDIS RESE"RCH GRO#$ o5ers i%s )lien%s ull CRO seri)es

In addi%ion %o "CM seri)es i% o5ers

• Bios%a%is%i)s• Da%a Manageen%

• Medi)al @ri%ing

• $+ara)oigilan)e

• S)ien%i>) Consul%ing



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"#perience wit$ Remote Data Capture % Manageme


• Medida%a R"&E s/s%e

• RDC Ora)le s/s%e

• Ini%ia%or eCRF s/s%e• S)ien)e and %e)+nolog/ on e)ien% inora%ion s/s%es

and s%ud/ .lanning %ools (IM$"CT1 Cognos )lini)al %rial

.lanning s/s%e e%)',

and o%+er )lini)al %rial anageen% s/s%es

• Cos% %ra)ing %ools



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"#perience: Study ypes




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"#perience: $erapeutic Areas




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Countries



"CM +as oni%ored and .erored oersig+% isi%s in%+e ollo*ing )oun%ries

L "us%ria L Israel

L Ce)+ Re.ubli) L a%ia

L Fran)e L Ke%+erlands

L Geran/ L $oland

L Grea% Bri%ain L S.ain

L Hungar/ L S*i%erland

L I%al/


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Contact


lli d li i l

Allied Clinical Management &m'H M"D(S R"&RO)P

Berlin o)e inoedis-resear)+')oBo/ens%raNe 4? ***'edis-resea?0??A Berlin

Tel 4 60 - 240 4 == 0 4 60 - 240 4 == 22Fa34 60 - 240 4 == 2 22

inoallied-)lini)al')o


ACM Presentation 2014

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