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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
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• 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
DO IT RIGHT THE FIRST TI
***'allied-)lini)al')o
• 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
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• "))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
***'allied-)lini)al')o
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Study Management
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• 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.
***'allied-)lini)al')o
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Study Management
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• 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*
***'allied-)lini)al')o
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Study Monitoring
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• 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
***'allied-)lini)al')o
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Study Monitoring
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• 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
***'allied-)lini)al')o
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Study Documentation
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• 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%)',
***'allied-)lini)al')o
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Proofreading and ranslation
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• $rooreading and %ransla%ion o s%ud/ .ro%o)ols1 .a%ien% diaries1
.a%ien% inora%ion and inored )onsen% and o%+er e/
)lini)al %e3%s• Ka%ie Englis+ and Geran s.eaers
***'allied-)lini)al')o
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!ull Service
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MEDIS RESE"RCH GRO#$ 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
• $+ara)oigilan)e
• S)ien%i>) Consul%ing
***'allied-)lini)al')o
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"#perience wit$ Remote Data Capture % Manageme
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• 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
***'allied-)lini)al')o
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"#perience: Study ypes
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***'allied-)lini)al')o
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"#perience: $erapeutic Areas
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***'allied-)lini)al')o
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Countries
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***'allied-)lini)al')o
"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
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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
***'allied-)lini)al')o