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Reduci ngCl i ni calTr i alCos t s& St r eaml i ni ng eSol Dat aWi t hNextGener a on Remot u ons ASpeci alRepor tForCl i ni calOper a on Execu ves& Strategi cDi rectors

I MPROVEDCLI NI CAL MANAGEMENT


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Reduci ngCl i ni calTr i al Cost s& St r eaml i ni ng I NDUS TRYANAL YSI S Da t aWi t hNex tGener a on RemoteSol u ons . Al lf ac t sandďŹ g ur esi nt hi sbook l et are dr awn f r om recogni zed s our ces ,orf r om act ualr es ul t s exper i encedbyRemot eTr i al empl oyees .Fi gur esar ei nU. S. dol l ar s . Theaut hor sandpubl i s her shave t ak enc ar ei npr eper a onoft hi s r epor t ,butmak enoex pr es s edor i mpl i edwar r ant yofanyk i ndand assumenor esponsi bi l i t yf or er r or soromi s s i ons . Phubl i s hedby : Remot eTr i al ,I nc. 3201Budi ngerAv e. St .Cl oud,FL34769 Copy r i ght2014 Remot eT r i al ,I nc . www. Remot eT r i al . c om

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“ Butt hec hal l engeof r es ear c hi ngnew c ompundsandbi ol ogi c s havenotgoneaway , ev eni ft hebudg ethas . ”

Ex ec u veSummar y TheeRemot epl a or mi sacos teffec vesdi r ectt opa entcl i ni calr esear chsol u on t hatdel i ver shi ghqual i t ycl i ni caldat aanddynami cpa entengagementmodul est o s t udys t akehol der s,boggeddownbyi ncr easedcompl exi t yandr i si ngcos t s,unl i ke cur r entcl i ni calsol u ons,t hatdemandcos t l ydecent r al i z edoneoffsol u ons.

I NDUS TRYANAL YSI S

Near l yal lResear ch&Devel opmentdepar t ment sar eunderpr essur et ocont ai n cost s;i nf actmanyar ebei ngaskedt or educeR&Dbudget sby20%.Butt he chal l engeofdevel opi ngnewcompoundsandbi ol ogi cshavenotgoneaway ,even i ft hebudgethas.I nf act ,t omany ,t hey’ vebecomemor eacut e. Andmanys t udysponsor sneedbe ersol u ons,t oweat hercutbacksi nanFDA r egul at edenvi r onment .Forexampl e,manyGl obalTr i alcoor di nat or sar el ooki ngf or qui ckerr esponset of as t changi ngcondions,ands t r ongerdeci si onsuppor tt ohel p gener at et hebes tpos s i bl ecl i ni calout comesf r om t oday’ schal l engi ngci r cums t ances. And,t heyneedi tnow. Buthowcanagl obalBi ophar maceu calor gani z a onpossi bl ymakecut sandi nves t i nnewsol u onsatt hesame me? Theans weri sbyt hi nki ngs t r at egi cal l y ,t ocr eat enewsol u onst hatr educespend andi ncr easeeffici enci es.Thecur r entR&Dr es t r uct ur i ngenvi r onmenti sani deal mef ors t udysponsor st omakecar ef uli nves t ment si nkeyar east hatwr i ngi n be ercl i ni calout comesf r om smal l erR&Dbudget s. Thi sspeci alr epor tl ooksatonewayCl i ni calOper a onExecu vescanr ol lout si gni ficant l ymor epower f ulcl i ni calmanagementf unc onsatanaffor dabl ecos t :by ext endi ngexi s ngsyst emswi t hspeci al i zeddi r ectt opa enteRemot esol u ons del i ver edasaser vi ce( SaaS) . Looki ngatt hel i mi t eddi r ectt opa entsol u onsnow bei ngusedf or gl obal r esear ch—t hi spaperconcl udest hats t udys t akehol der swoul dbewi set oconsi der ext endi ngt hesef unc onswi t hSaaS,asawayt ot r ul y“ domor ewi t hl ess. ”

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Pr obl ems Cos tt odev el opas i ng l e appr ov eddr ug(*Projecon)

$1, 821M1*

5Y earc os tv ar i a onpers t udyparc i pant ( 20082013) Phas eI Cl i ni c alT r i al

( *Mi l l i onsofUSDol l ar sI n$2013dol l ar s Us i ngGDPI mpl i c i tPr i c eDea t er )

Phas eI I I Pi v ot alT r i al

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( per pa entc os t )

$1, 241M $900M $393M

1982

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2015

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$15k

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$ 2 5 . 7 k

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+108%

Gr owt hi nT r i alCompl ex i t yandPa ent sPerT r i al

$48. 5k

20082013

+157%

Me d i a nn u mb e r o f C RF pag esperpr ot oc ol

227%

T ot a l s i t ewor kbur de n

64%

El i g i bi l i t yc r i t er i aper pr ot oc ol

58%

T ot alpr oc edur eper pr ot oc ol

57%

Me d i a ns t u d yd u r ao n i nda y s

25%

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Cl i ni c a l T r i a l S pe ndi npe r c e nt a g e t o2010I ndus t r yI nde xAv er a g e

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+57% USA S i t eS pend

X X / X X / X X X X

EDC

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C l i n i c a l Op e r ao n s

C l i n i c a l Op s

3 0 0 0 0 0 0 0 0 9

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+65% E x US A S i t eS pend


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Sol u ons eRemot eAv er ag eCos tVar i a onpers t udy parc i pant( 2013Av gI ndex )

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$38k

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e R o t i n i c a l T r i a l S p e n di nc o mp a r i s o n Re em mo te e:Cl t oI ndus t r yI nde xAv e r a g eI nPe r c e nt a g e

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47% USA

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Remot eT r i aldel i ver s c onfigur abl ec l i ni c al moni t or i ngwor kflows t or educ ec os tand i nc r eas epr oduc vi t y .

I nt r oduc i ngRemot eT r i al seRemot ePl a or m e

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I ns t antaccesst opa ent sands t udydat adel i verac onabl eout comesf orf as t er , r eal medat adr i vendeci si ons.

I NDUS TRYANAL YSI S

Remot eTr i al seRemot ePl a or mi mpr ovesCl i ni calOper a onsi nt oamor eagi l e, i nnova ve,andeffici entpr ocess. TheFDAr egul at or ycompl i antpl a or m pr ovi desr eal -mepa entmoni t or i ngand gl obalt r i alover si ght ,soyouror gani z a oni mpr ovespa entout comes,r educest r i al st udy cost swhi l ei mpr ovi ng communi ca ons,col l abor a onandqual i t yf oral l s t akehol der s. Wi t heRemot est el eheal t hpl a or m andaut omat edwor kflows,al er t s,escal a ons andaudi tt r ai l s,yourt eam canpr ovi de“ac onabl eout comes”t hatl owercos t s whi l ei mpr ovi ngqual i t yandcompl i ance-akeybenefitt hatnot r adional cl i ni calmanagementpl a or m ors ys t emsoffer s. I naddiont ol ower i ngi t scos t st hr oughi ncr easedpr oduc vi t y ,youror gani z a on r educesi t sover al lcos tofowner shi pwi t heRemot es“So war easaSer vi ce( SaaS) ar chi t ect ur e.I nt egr a oni sst andar di zedt hr oughpr ebui l tdat aaccel er at or s andi mpl ement a onpl ans,soyoupayonl ypers t udycos t s. Remot eTr i al smodul ardesi gnl et syousel ectt her i ghtt el emoni t or i ngcapabi l ies f oryourparcul ars t udyormoni t or i ngengagement .Al l owi ngi mpl ement edand managedr emot es t udi eswi t hi mpr ovedcoor di na onandcont r ol . Thecl oudbasedar chi t ect ur esi mpl i fiesuseraccessandr equi r esonl yani nt er net connec on.Noneedf oraddionalhar dwar eorso war e. Youror gani z a oncanaddnewf eat ur eswi t hnodi sr up ont oyouror gani z a on. Wet akecar eofever yt hi ngbehi ndt hescenes.

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I NDUS TRYANAL YSI S

Remot eTr i alCol l abor a oni nt er f acesl ever agesdi r ectt opa enti nt er f aces wi t hapower f ult el eheal t hpl a or mt ost r eaml i necommuni ca ons.Teams sharei nf orma on,col l aborateandstayconnected.Thesecure, r ol ebasedenvi r onmenti sf orus ebyi nvesgat or s ,pr ogr am t eams ,ands t udy parci pant s.Col l abor a onacr ossst at eandi nt er na onall i nesensur est udy or gani za onsgr eat erengagementandi mpr ovedpr oduc vi t y . eRemoteAnal y csPortali sast at eof theartuserf r ameworkthat aut omat est hecapt ur eofr emot epa entdat aandl ogi cal l ygr oupspa ent s i nt oi nt uivewor kflowst ohel pel i mi nat equer y' sandsetoffal er t swhen noncompl i ancei ssuesari se vi apre-approvedi ndi cators,whi ch i nt uivel ycat egor i zepa entdat ar eal me.eRemotei nstantl yprovi des st udypr ogr essandno fica onst ouser sbyaut oma ngs t r at egi cmi l est ones t os peci al i s t ,r es ear chs i t eandpa ent st her ebyenabl i ngpr oacvemanagement . Runni ngbehi ndt hescenes,audi tt r i al scon nuousl yt r ackandr ecor dac ons f ori mpr ovedaccount abi l i t yandcompl i ance.

Por t alwi t hRol eBas edVi ews F DAAppr ov edT el ehea l t hGa t e wa y Al er t s ,Es c al a ons ,No fic a ons Config ur abl eWor kflows T r i ag eVi deoConf er enc eCal l s 21CF RPar t11Compl i ant Config ur abl eCas eRepor tF or m I nt er acv eI VR&T ex tNo fic a on Res ear c hS i t eRec r ui t ment Cal lCent er /Hel pDes kS uppor t S uppl yManag ement&Del i v er y Onl i neF or mL i br ar y /eDi ar yAPI

Por t alWi t hRol ebas edVi ews Al er t s ,Es c al a onsNo fic a ons Da t aRepos i t or y Anal yc sandDas hboar ds Dev i c eI nv ent or yT r ac k i ng Us erAcv i t yMoni t or i ng S i t eEnr ol l ment&T r ac k i ng I den t yVer i fic a on T r ai ni ng&E duc a onCompl i anc e

eRemot eTool boxi sas ui t eofop onalmodul est hatf ur t heri mpr oveoper a ons andeffici enci es. eLear ni ng-ensur est r ai ni ngcompl i ancebydel i ver i ngondemand,24/ 7t r ai ni ng vi at hepor t al ,t r ai ni ngwor kflowsandal er t s.I ns t r uct orl ededuca oncl asses f aci l i t at euseradop onwi t hi nyouror gani z a on. Cust omerTr ai ni ng-Remot eTr i al sPl a orm i saf r i endl yandi nt uive gr aphi cali nt er f acet hatf aci l i t at euseradop on.Remot eTri aldel i ver s cust omert r ai ni ng,devi cedel i veryi nst al l a onst omaxi mi z euseradop on. Si t e&Pa entPayment s-I ndi vi dualsi t esand Resear chspeci al i s tmayl ogon t oeRemot epaymentpor t alf orr eal mecl i ni calac vi t yver i fica onal l owi ng f ordet ai l edpaymentr econci l i a on.Paymentr econci l i a onf orr emot es t udy parci pant saut opayvi apr edesgnat edpaymentcar dsoncever i fieds t udy mi l es t oneshavebeenmet . WebSer vi ceAPI -eRemot eoffer sar obus ti nt egr at abl eoper a onaldat amodel f orcur r entpr ovi der sandt echnol ogyvendor st or api dl yi nt egr at ef ordat a shar i ngbet weenexi sngs ys t ems.

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