clinical data management 1216360964016453 9

7/24/2019 Clinical Data Management 1216360964016453 9

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C L I N I C A L D A T A

M A N A G E M E N T S Y S T E M & S O

F T W A R E S

BII Training Programs www.bii.in/biodlp

PRESENTATION ON

CLINICAL DATA MANAGEMENT

SSTEM ! SO"T#ARES

B$

SNIGD%A DEBNAT%

BIOIN"ORMATICS INSTIT&TE O" INDIA

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M A N A G E M E N T S Y S T E M & S O

F T W A R E S


INDE'

CLINICAL DATA MANAGEMENT SSTEMINTROD&CTIONNEED

"&NDAMENTALS O" CLINICAL TRIAL SO"T#ARE

ORACLE CLINICAL SO"T#ARE

SAS CLINICAL SO"T#ARE

TCS CLIN(E)E SO"T#ARE

COGNOS * B&SINESS INTELLIGENCE SO"T#ARE

SMETRIC SO"T#ARE


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M A N A G E M E N T S Y S T E M & S O F T W A R E S


INDE'

A+A,A-S OPENCLINICA SO"T#ARE

SIGMASO"T-S DMSS SO"T#ARE

PROGEN CLINICAL SO"T#ARE

ABO&T BII

BII-s PROGRAMS IN CLINICAL TRIALS


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CLINICAL DATA MANAGEMENT SSTEM

INTROD&CTION

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CLINICAL DATA MANAGEMENT SSTEM

NEED "OR CLINICAL DATA MANAGEMENT

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"&NDAMENTALS O" CLINICAL TRIAL SO"T#ARE

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on in50sm0n 3ig30r.

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Oral0 Clinial is a sop3isia0d sol2ion 3a 30lps on0 m00 30 bigg0s 3all0ng0$ 3ow o g0 o mar04as0r in oda1-s ompl0= b2sin0ss and r0g2laor1 0n5ironm0n.

Abo2 Compan1

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Smoo3 ransiion 4rom pap0r o EDC 6El0roni Daa Cap2r07 rials.

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Abo2 So4war0

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SAS r0ord o4 r050n20 grow3 050r1 10ar9 sin0 H;9 0nabl0s r0in50sm0n o4 a s2bsanial p0r0n o4r050n20s in R!D 0a3 10ar 6) p0r0n in )@@;7.

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SAS sr0amlin0s daa in0graion o 0radia0 0rrors and man2al wor 3a d0la1 bringing no50l 30rapi0s omar0.

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Abo2 Compan1

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T30 so4war0 is load0d wi3 30 4ollowing 42nionalii0s$

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Ens2r0s 30 prop0r 2s0 o4 sandards b1 anal1sing bo3 30 sr22r0 and 30 on0n o4 30 daa and 2sing CDISC sandards s23 as ODM and SDTM.

B1 2sing SAS o manag0 and a2oma0 daa in0graion9 daa 82ali1 and omplian0 wi3 ind2sr1 sandards9 on0 an 4r00 2p 5al2abl0 r0so2r0s o wor on mor0 ompl0= and sra0gi pro0s9 and 30n09 sa50 im0.

Abo2 So4war0

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and m0dial d05i0s ind2sri0s.

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Abo2 Compan1

Esablis30d in H*9 Taa Cons2lan1 S0r5i0s 3as grown o is 2rr0n posiion as 30larg0s IT s0r5i0s 4irm in Asia. TCS is a pr040rr0d allian0 parn0r o4 mos l0ading ITprod2 and pla4orm ompani0s9 inl2ding Oral09 SAP9 Miroso49 IBM and %P9 amongo30rs.


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+01 "0a2r0s$

Protocol Driven Ens2r0s in(b2il 5alidaion aross 30 0nir0 Daa Manag0m0n Pro0ss.

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$%er# M!n!e'ent Wor()lo* Rol0(bas0d 820r1 manag0m0n wor4low 4or daa modi4iaion and orr0ion.

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Re%l!tor# Co'"li!nce Complian wi3 ) C"R Par 9 GCP.

D!t! St!n+!r+ b!e+ M00s 30 CDISC ODM and SDTM Sandards.

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Cognos- li0n lis9 w3i3 oda1 0=00ds ):9@@@9 also inl2d0s a broad rang0 o4 li40 si0n0 and 30al3 ar0

ompani0s.

Earl1 adop0rs o4 03nolog1 3a50 impl0m0n0d s1s0ms li0 EDC and CTMS 3a ar0 poin sol2ions and o440rlimi0d d0ision s2ppor. B1 a2ra0l1 m0as2ring sp00d o mar09 im0lin0ss in d050lopm0n9 daa 82ali19and 30 p0r4orman0 o4 p0rsonn0l and parn0rs9 Cognos ma0s manag0m0n o4 linial daa simpl0r and30n09 impro50s p0r4orman0.

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Abo2 Compan1


http://www.cognos.com/index.html




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M A N A G E M E N

T S Y S T E M & S O F T W A R E S



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D!,bo!r+ & Scorec!r+

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Monior p0r4orman0 agains 01 mil0son0s s23 as in50sigaor s0l0ion9 IRBs or

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a naional9 r0gional9 0rrior1 and prod2 l050ls 2sing das3boards and sor0ards.





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M A N A G E M E N



SMETRIC SO"T#ARE

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SMETRIC SO"T#ARE

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M A N A G E M E N



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ABO&T BII PROGRAMS O""ERED

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IND&STR PROGRAM IN CLINICAL TRIALS9 RESEARC% ! ADMINISTRATION 6) MONT%S DISTANCE PARTICIPATION PROGRAM7

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ADANCE PROGRAM IN CLINICAL TRIALS9 RESEARC% AND DATA MANAGEMENT

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