Life Sciences. White Paper. The Clinical Trial Supplies Control Tower: Gain End to End Visibility for your Clinical Supplies

Transcription

1 Life Scieces White Paper The Cliical Trial Supplies Cotrol Tower: Gai Ed to Ed Visibility for your Cliical Supplies

2 About the Authors Yezhuvath Viesh Balakrisha Yezhuvath Viesh Balakrisha works i the TCS Life Scieces vertical focusig o the supply chai maagemet domai. He has over 22 years of experiece i supply chai maagemet, maufacturig, process excellece ad IT maagemet across pharmaceutical ad chemical idustries. A alumi of Birla Istitute of Techology ad Sciece (BITS Pilai), he holds a graduate degree i Chemical Egieerig ad a postgraduate degree i Mathematics. He combies process orietatio ad aalytical abilities with a i-depth uderstadig of techology to develop IT solutios that drive productivity, efficiecy ad goverace i the life scieces supply chai ad maufacturig domais. Viesh is actively ivolved i umerous supply chai as well as outsourcig trasformatio iitiatives. As a member of several groups withi TCS as well as with cliet ad parter ad/or alliace orgaizatios, he has helped coceptualize ad develop iovative solutios, as well as eabled process optimizatio.

3 Abstract Accordig to idustry reports,¹ the global cliical trial outsourcig market grew at a CAGR of 14%, idicatig the icreasig globalizatio of cliical trials, both i the pursuit of faster trials as well as market expasio. However, this tred is leadig to more complexities i the trial process. IMS Health estimates(²) that i order to elimiate the risk of avoidable desig defects as well as patiet recruitmet issues, a sposor speds USD 26 millio o ruig 100 cliical trials a year. 60 percet of approximately USD 110 billio spet by the idustry aually o global R&D, or 6.5 percet of the reveues is devoted to cliical trials. The evolutio of the Fuctioal Service Model by cliical research orgaizatios (CRO), which heralds the chagig busiess models of egagemets for cliical trial maagemet, is addig icreased odes to the cliical trial supplies value chai. Studies idicate that: 80 percet of all cliical trials are delayed by more tha a moth, leadig to a estimated loss of USD 1 millio. Oe i three of all ivestigative sites fails to eroll more tha a sigle patiet. There are roughly three amedmets per protocol, a third of which could have bee avoided. Each protocol amedmet causes a delay i excess of 50 days. Recruitmet difficulties alog with protocol desig flaws lead to 20% of such amedmets Cliical supply chais ca be more resposive if there is a early idicatio of the probability of occurrece of such challegig situatios. A moder cotrol strategy for iteral efficiecy ad effectiveess helps esure that evets are captured ad aalyzed i real time, eablig the supply chais to respod easily beyod time zoe, geography ad laguage barriers. This paper highlights how the cocept of the cotrol tower ca be leveraged to make the cliical supply chais more resposive if there is a early idicatio of the probability of occurrece of such challegig situatios. A moder cotrol strategy for iteral efficiecy ad effectiveess helps esure that evets are captured ad aalyzed i real time, eablig the supply chais to respod easily beyod time zoe, geography ad laguage barriers. [1] Tufts Uiversity, Tufts Ceter for the Study of Drug Developmet Impact Report,, Vol. 13, Number 5, 2011 [2] IMS Istitute for Health Iformatics(2012), The Global Use of Medicies: Outlook Through 2016, July 2012

4 Cotets 1. Itroductio 5 2. The Cliical Trial Ecosystem 6 3. Role Of A Cotrol Tower I The Cliical Supply Chai 7 4. Overview Of The Cliical Trial Supply Chai 9 5. Process Of Buildig A Cliical Trial Supplies Cotrol Tower Coclusio 13

5 1. Itroductio Cliical trials are gettig more global, complex, larger ad focused, with CROs facig added pressure to complete them faster. Figure 1 is a sapshot of the curret operatig eviromet i cliical trial supplies orgaizatios. Key stakeholders i the ecosystem alog with critical objectives ad challeges of cliical trials defie ad ifluece this eviromet. Pharmaceutical Curret Outlook The Ecosystem Service Providers Parters Govermet Trials Pharma Compay Techology Providers Healthcare Reforms New Laws Product Data Adaptive Trial Emergig Markets Geerics Patiet Protectio Emergig Stadards Reduce Cost Global Lauch Key Objectives Faster Trials Lower Costs Key Challeges Moitorig Visibility Compliace Figure 1: Several Ifluecers ad Challeges affect the Operatig Eviromet i a Cliical Trial Supply Chai Pharmaceutical compaies are expadig their cliical trial reach ito ew coutries. They are also ehacig their portfolio i existig markets ad itroducig ew products faster i the emergig markets, to reduce or cotai costs. Cliical trials are also witessig chages i terms of adoptio of stadards, adaptive cliical trials (or virtual cliical trials), ad striget labelig requiremets for drugs. The growig tred of outsourcig ad the rise of specialist orgaizatios mea that the permutatios ad combiatios betwee trial sites, cliical materials ad services offered are resultig i icreasig umber of supply chai odes. 5

6 A few pressig challeges that cotribute to icreased ucertaity i the value chai iclude: Upredictable trial duratio ad staggered subject recruitmet. Processes relatig to maagemet of overage materials, moitorig of shelf life ad expiry, cotrolled trasportatio, compliace with labelig requiremets i global trial scearios, ad re-labelig ca suffer - due to the lack of or limited real time visibility ito cliical material locatio. Trade compliace, if ot maaged properly, leads to delays i customs clearace, impactig timelies ad the ability to predict ETA (Expected Time of Arrival) accurately. Sub optimized ad/or ureliable processes impact the drug recociliatio process, leadig to trial closure delays ad compliace issues. 2. The cliical trial ecosystem The cliical trial supplies (CTS) value chai is subjected to the pulls ad pressures of the operatig eviromet that comprises elemets such as iteral trial objectives, operatig laws, regulatios ad competitive forces. The CTS value chai ad the ecosystem (illustrated i Figure 2) eeds a foudatio for ed-to-ed visibility to secure a tighter aligmet of supply ad demad plaig while eablig faster decisio makig ad executio. Cliical Supplies Ecosystem Value Chai Develop Dosage Maage Forecast Make Cliical Product Deliver Cliical Product Dispese Ivestigatioal Drug Recocile Ivestigatioal Drug Drug Regulatory Bodies Packagig Compaies Pharmaceutical Compay Suppliers Cliical Research Orgaizatios Cliical Supplier Cotract Maufacturure Logistcs Compaies Distributio Compaies Destructio Agecies Cliics & Hospitals IVRS/IWRS Compaies Cliical Ivestigators Trial Subjects Etities that regulate or gover the Cliical Trial Supplies Etities that the pharmaceutical compay collaborates for Cliical Maufacturig Etities that the pharmaceutical compay parters with to Distribute Ivestigatio Products Etities that are pharmaceutical compay parters for Cliical Study Outcomes Etities for which the pharmaceutical compay exist to develop cures Figure 2: Comprisig several stakeholders, the cliical trial supplies value chai ad ecosystem is complex ad dyamic. 6

7 Pharmaceutical compaies collaborate with cliical research orgaizatios (CROs), cliics/hospitals, techology platform vedors such as IVRS systems, packagig ad cliical maufacturig uits, labelig etities as well as simulatio ad modelig experts to make a drug therapy commercially feasible. Medicies or drug therapies are made i the cliical maufacturig sites of the pharmaceutical or its parter compaies ad trasferred to cliical warehouses. These products are sometimes subjected to price egotiatios, ad price cotrols by group purchasig orgaizatios, pharmacy beefit maagers (PBMs), ad govermet health programs. They are the delivered to cliical ivestigators, who dispese these items to trial patiets. For smooth operatios withi this value chai, all stakeholders eed to operate i compliace with regulatios, guidelies ad procedures defied by drug regulatig agecies of all the coutries they operate i. 3. Role of a Cotrol Tower i the Cliical Supply Chai The supply chai cotrol tower, also referred to as operatios ceter, supply chai radar or commad ceter, is a locatio or cetral hub that provides visibility ito the iboud ad outboud material ad iformatio flows, ad serves as a exteded meas for ed-to-ed visibility. It provides a cetralized view of the plaig ad executio systems across the exteded eterprise for sesig, recogizig, ad respodig to chages i supply ad demad. The cotrol tower approach offers visibility ito supply chai evets, ad like a radar, eables quick idetificatio, verificatio ad cotrol of situatios that might disrupt desired results Key Attributes of a Cotrol Tower The cotrol tower is a techology drive cocept. To be effective, all fuctios, orgaizatios, ad processes eed to be combied with techology to provide strategic, tactical ad operatioal level cotrol for the cliical trial supplies value chai. Effective program goverace, tradig parter or ecosystem parter coectivity, strog aalysis capabilities, ad quick decisio-makig mechaism are the foudatioal elemets of a reliable cotrol tower desig. P&G Deploys Commercial Cotrol Towers P&G istalled 'cotrol towers' to hadle distributio i its emergig markets. They allowed a comprehesive ad complete view of iward ad outward movemet of goods - just like a airport cotrol tower that directs the path of a airplae. The cotrol towers helped i deliverig maximum truck fill for every kilometer travelled i the fastest possible time, i a ecologically friedly maer. It ca serve as a powerful avigatio tool to cotrol operatios by: Eablig log term ad short term decisio-makig i lie with strategic goals ad objectives. Brigig together data from differet sources for aalysis. Geeratig visual data for ehaced visibility to idetify emergig risks Simulatig cosequeces of the various decisio optios. Executig ad trackig the decisios take. 7

8 Attributes for a Cliical Trial Supplies Cotrol Tower Program Goverace Tradig Parter Coectivity Digital Cliical Trial Supplies Cotrol Tower Aalytical Capability Decisio Process Figure 5: A Cliical Trial Supplies Cotrol Tower Provides Several Strategic Beefits Leveragig Cotrol Tower for Ed-to-ed Visibility Visibility, although seemigly very simple, becomes eormous i the cotext of cliical materials, as it deals with iformatio flow ivolvig people, processes ad techology. Visibility i cliical supply chais demads real time commuicatio betwee the differet odes of the cliical trial etwork. From a IT perspective, it is the ability to collect ad aalyze distributed data, geerate specific observatios ad recommedatios, ad provide isights ad actioable iformatio to make smart decisios. Improvemets i RFID techologies, advaces i ear field commuicatio, ad advaces i packagig techologies alog with the ubiquitous presece of mobile etworks eable the desig of smart cupboards. These work with smart packagig ad smart labelig to eable effective real time distributio of products, leadig to better ivetory maagemet, as well as improved drug recociliatio. Aother example is the use of mobile with a Bluetooth-eabled reader that ca sca a previously barcoded drug ad track movemet ad dispese to patiets. The process facilitates automated capture of iformatio that is liked to the patiet, ad used to update the case report form (CRF).What this also etails is a costat moitorig of sesors to esure that the devices are operatioal for requisite evet triggers. The CTS Cotrol Tower should provide this clear all roud visibility of the cliical supplies movemet, as well as the factors that ifluece that movemet such as import clearaces ad temperature cotrols. 8

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10 4. Overview of the Cliical Trial Supply Chai Cliical trial supply chai is large, complex ad global comprisig several stakeholders ragig from raw material providers, distributors, ad marketers to customers. Two key characteristics of the supply chai iclude: Treatmet Week is 18 weeks Oe IND, 4 Dosage Forms Oe Comparator Erollmet Period 28 Moths Program Goverace Oe Placebo Subject Ratio 50:40:10 Study i 3 Cotiets 5 Ivestigator per city 50 Cities Figure 3: Cliical Trial Supply Chai comprises complex processes Uiqueess ad Complexity Key requiremets such as patiet safety, product trackig, short expiry cycles, varyig regulatios, as well as issues such as patiet retetio ad data accuracy result i a complex ad uique CTS ecosystem. Its complexity is best illustrated with the help of a example. Cosider a case of oe active igrediet, leadig to oe Ivestigatioal New Drug (IND) ivolved i the cliical study arms - with four dosage forms, oe placebo ad oe comparator, to be coducted i six coutries across three cotiets. This results i a sigificatly large umber of supply chai odes for a relatively small quatity of materials that eeds to be distributed across cotiets ad sites over a exteded period, uder cotrolled coditios. This is to esure that the right drug goes to the right subject at the right time i the right coditio, every time a patiet is erolled. Cliical trial supply chais are also characterized by differetiated etworks, short respose time, flexibility, trasparecy, ad outsourcig competecy. The chai must be equipped with well-defied flexible ad adaptive strategies to support cliical study programs related to ivestigatioal drug, placebos ad comparators. Agility ad Resposiveess While cliical trial supply chais eed to be quick to respod to high expiratio ad low volume situatios, the typical practice is to use aticipatory demad models created far ahead of the eed. The factors that determie or drive the calculatios are characterized by a high degree of ucertaity, ad this is a cause for sigificat cocer. 9

11 This apart, the advet of regulatios related to cold chai, ad the gradual acceptace of adaptive cliical trials demad trasitio from a build-to-stock approach to a more resposive agile supply chai. This costat pressure to achieve miimum lead time ad the lowest possible cost also makes the life of a cliical supply maager more difficult as well as iterestig. All of this requires cliical supply chais to be supported by seamless visibility across geographically distributed sites ad multiple chaels of access, ad itegrated with varied applicatios. The critical factor is that the supply chai has to be operative i a cotrolled ad flexible maer, through the adoptio of best work practices to promote global utilizatio of resources. Icreasig Collaboratio Ecosystem Mergers, Acquisitio Novel Parterships Global Lauch Plas Emergig Markets Expasio Emergece of Fuctioal Service Provider Objective Miimum Lead Time Optimize Costs Outsourcig Shrikig R&D Budget Faster Trials Upredictable Trial Duratio Lack of Effective Stability data Material Overage Lack of Effective Stability data Material Overage Objective Lowest Cost Icreasig Compliace Needs Healthcare Reforms Trade ad Tax Regulatios Cold Chai Trasportatio Trade Compliace Emergig Regulatios Drug Accoutability & Recociliatio Objective Reliability Figure 4: Miimum Lead Time, Low Cost, ad Reliability are the Key Objectives of Cliical Supplies Compaies Figure 4 illustrates the three critical objectives of cliical supplies orgaizatios. Therefore, the followig issues eed to be addressed effectively by the CTS cotrol tower: - How it plas to cope with the icreasigly collaborative ecosystem - How it ca achieve a high degree of compliace - How it iteds to esure the lowest possible trial supplies TCO - How it proposes to exploit the advacemets i smarter packagig 10

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13 These questios ecessitate a icreased (ear) real-time supply chai visibility, multi-player moitorig ad effective compliace, with a strog focus o the growig supply chai risk. Furthermore, ew disruptive techologies like digital applicatios ad the collaborative ature of specialized commuities, alog with the rise of the Iteret of Thigs or sesor-based evet applicatios provide a opportuity for improved outcomes. This sceario therefore demads a revisit of the goals ad priorities of the cliical trial supply chai fuctios. The cliical trial supply orgaizatio ca meet the challeges through ew processes, revamped skills matrix of its people ad better orgaizatio ad itegratio of systems with a iovative digital strategy. The cliical trial supply team eeds to exercise complete cotrol over their data ad supportig tools to pla ad maage the flow of materials betwee parters, subjects ad ivestigators. Drivig this iitiative is the CTS Cotrol Tower the pricipal strategy tool for cliical trial operatios. 5. Process of Buildig a Cliical Trial Supplies Cotrol Tower Creatig a effective cotrol tower requires cosolidatig iformatio from several sources. This helps build a holistic two-tiered system that cosists of the cotrol tower, as well as uit towers for plaig, trackig ad decisiomakig Itegratio of Iformatio The cliical trial cotrol tower is realized by itegratig iformatio residig i several systems withi the exteded ecosystem. Miute details of every trasactio related to - placebo/comparator orders from a supplier, products maufactured across locatios, documets created, shipmets to ad from a site, dispesatio to subjects (patiets) erolled i a trial, paymets due ad paid to a site or ivestigator, ad evets i the chai are captured, aalyzed ad acted upo. The actios take are recoded, commuicated ad tracked to closure. To achieve the aticipated results, the cliical trial supplies cotrol tower eeds to deal with the immediate real world logically ad effectively Visio for the Cotrol Tower The visio for the cotrol tower is evisaged as a two tier structure (see Figure 6.) with the top tier providig a complete view of the cliical supplies orgaizatio, ad the secod tier comprisig uit cotrol towers for each of the key fuctios withi the cliical supplies. 11

14 Tier 1 CotrolTower DCTS Cotrol Tower 360 Degree View Sceario Aalysis Impact Aalysis Risk Aalysis Re-plaig Scearios Tier 2 Uit Tower Plaig Uit Cotrol Tower Plaig View Dyamic Plaig Capability Issue Cotextual Actio Track Actio / Respose Operatios Uit Cotrol Tower Track Evets Track Billig Track Trasport Maage Storage ARC Uit Cotrol Tower Audit Trackig Recociliatio Paymet Ivetory Compliace Trackig Simulatio Uit Cotrol Tower Decisio Makig Quick Sceario Evaluatio Cliical Data Exchage Hub Sematic Egie Platform as a Service PaaS for Iteret of Thigs Ope Stadards PaaS Aalytical Egie Pharma Compay Systems CMO Parter Systems Logistics Parter Systems Other Third Party Systems CRO Parter Systems Figure 6: The Two Tiered Cliical Trial Supplies Cotrol Tower Offers a Holistic Visio of the Cliical Trial Supply Chai Ecosystem Pharmaceutical compaies owed systems, ad third party-systems owed by ecosystem parters are coected through a data exchage hub. This hub should be built usig existig as well as emergig stadards to support stadardized iformatio exchage with least disruptio to the parter system. CTS is best delivered as a hybrid Platform-as-a-Services. Existig techologies like RFID, barcode ad emergig treds like Iteret of Thigs/machie-to-machie should be utilized to provide faster ad stadardized iformatio for logistics ad documetary evets. This ca help stregthe CTS capabilities to trasfer ad aalyze vast amouts of data, as well as process ad preset the output as a cotiuous feed to idividual cotrol tower uits. It ca thus brig together elemets of discrete evet simulatio, ad ecosystem social collaboratio to achieve greater visibility. Cotrol towers must be desiged with ed objectives of a cliical supplies compay i mid. Key factors to be cosidered while desigig the two-tier visio iclude: The Tier 1 uits ca be desiged i lie with orgaizatioal or assiged resposibility. They are ot iteded to replicate specific busiess process fuctioalities like forecastig, or maufacturig. For example the simulatio uit is focused o simulatio, forecastig ad optimizatio of evet statuses. 12

15 It is essetial to build a efficiet ARC (Audit, Recociliatio ad Compliace) uit, which keeps track of audit, recociliatio ad compliace evets. It issues the eeds for compliace, as well as tracks the progress or adherece to key requiremets. The ARC uit ideally geerates alerts ad evets to esure effective compliace with importat requiremets such as cotrol temperature shipmets. It also keeps track of the cliical supply costs. Cotrol towers eed to be customized based o orgaizatioal factors icludig the scope, processes, fuctios ad geographic reach. A etwork of cotrol towers usig a cetral ad a series of regioal towers is yet aother optio. 6. Coclusio Dyamic market chages demostrate a eed for more collaborative IT solutios that ca address ew risks across the cliical trials supply chai. The cliical trial supplies cotrol tower provides for the executio of a moder cotrol strategy built o a digital foudatio. The advet of Iteret-of-Thigs, RFID eabled cliical supplies, cotrolled temperature shippig ad techology advaces i mobility have helped simplify the collectio of data, ad triggers evet iformatio to the cotrol tower. The ecosystem i which the cotrol tower should reside is already beig created, ad the sesor based applicatio as a service further makes it a cost effective solutio. While the cotrol tower provides for immediate actio i real time or ear real time, it also serves as a huge repository of iformatio. The cotrol tower builds up a huge accumulatio of evets ad resposes over a period of time, ad the richess of this data leds itself to big data based isights. CTS cotrol tower provides a strog digital strategy for cliical operatios, ad ca be easily exteded to the etire cliical trial operatios eviromet. It comprises digital elemets icludig evet sigals, pervasive computig, data velocity, seamless collaboratio, cloud platform, ehaced security, ad aalytics that eable digital re-imagiatio ³ for better busiess results. [3] The Digital Eterprise: A Framework for Trasformatio, Perspectives, TCS Cosultig Joural, 13

16 About TCS' Life Scieces Busiess Uit With over two decades of experiece i the life scieces domai, TCS offers a comprehesive portfolio i IT, Cosultig, KPO, Ifrastructure ad Egieerig services as well as ew-age busiess solutios icludig mobility ad big data caterig to compaies i the pharma, biotech, medical devices, ad diagostics idustries. Our offerigs help cliets accelerate drug discovery, advace cliical trial efficiecies, maximize maufacturig productivity, ad improve sales ad marketig effectiveess. We draw o our experiece of havig worked with 7 of the top 10 global pharmaceutical compaies ad 8 of the top 10 medical device maufacturers. Our commitmet towards developig ext-geeratio iovative solutios ad facilitatig cuttig-edge research - through our Life Scieces Iovatio Lab, research collaboratios, multiple ceters of excellece TM ad Co-Iovatio Network (COIN ) - have made us a preferred parter for the world's leadig life scieces compaies. Cotact For more iformatio about TCS Life Scieces Busiess Uit, visit: lshcip.pmo@tcs.com or visit Subscribe to TCS White Papers TCS.com RSS: Feedburer: About Tata Cosultacy Services (TCS) Tata Cosultacy Services is a IT services, cosultig ad busiess solutios orgaizatio that delivers real results to global busiess, esurig a level of certaity o other firm ca match. TCS offers a cosultig-led, itegrated portfolio of IT ad IT-eabled ifrastructure, egieerig ad TM assurace services. This is delivered through its uique Global Network Delivery Model, recogized as the bechmark of excellece i software developmet. A part of the Tata Group, Idia s largest idustrial coglomerate, TCS has a global footprit ad is listed o the Natioal Stock Exchage ad Bombay Stock Exchage i Idia. For more iformatio, visit us at IT Services Busiess Solutios Cosultig All cotet / iformatio preset here is the exclusive property of Tata Cosultacy Services Limited (TCS). The cotet / iformatio cotaied here is correct at the time of publishig. No material from here may be copied, modified, reproduced, republished, uploaded, trasmitted, posted or distributed i ay form without prior writte permissio from TCS. Uauthorized use of the cotet / iformatio appearig here may violate copyright, trademark ad other applicable laws, ad could result i crimial or civil pealties. Copyright 2014 Tata Cosultacy Services Limited TCS Desig Services I M I 08 I 14