CMIC: Japan’s lead­ing CRO fo­cus­es on the fu­ture of clin­i­cal tri­als with in­no­va­tion and dig­i­tal so­lu­tions

In last year’s fea­ture, we spot­light­ed CMIC Group as Japan’s lead­ing CRO, trans­form­ing clin­i­cal tri­als by stream­lin­ing process­es and bridg­ing gaps be­tween phar­ma­ceu­ti­cal com­pa­nies and Japan­ese med­ical in­sti­tu­tions. Fast for­ward to to­day, CMIC con­tin­ues to re­de­fine the land­scape of drug de­vel­op­ment, push­ing bound­aries with its in­no­v­a­tive ap­proach­es and ex­pand­ing ca­pa­bil­i­ties. Un­der the lead­er­ship of Kazuo Naka­mu­ra, CMIC Group con­tin­ues to grow its Site Man­age­ment Or­ga­ni­za­tion (SMO) bol­ster­ing its sup­port ser­vices for clin­i­cal tri­als with a ro­bust net­work of over 4,000 med­ical in­sti­tu­tions. CMIC’s com­pre­hen­sive ser­vices, in­clud­ing fea­si­bil­i­ty sur­veys and reg­u­la­to­ry over­sight, en­sure high-qual­i­ty tri­al op­er­a­tions. Mean­while their spe­cial­ist Clin­i­cal Re­search Co­or­di­na­tors (CRCs) and Site Man­age­ment As­so­ciates (SMAs) play key roles in pa­tient en­gage­ment and re­cruit­ment.

This year, CMIC is fur­ther ad­vanc­ing its mis­sion with cut­ting-edge dig­i­tal health so­lu­tions. Plat­forms like har­mo and nanacara are en­hanc­ing pa­tient-cen­tric care by in­te­grat­ing com­pre­hen­sive health da­ta and im­prov­ing re­cruit­ment and en­gage­ment process­es. Look­ing ahead to 2025, CMIC’s fo­cus re­mains on lever­ag­ing these dig­i­tal tools and ad­vanced tech­nolo­gies to sup­port in­no­v­a­tive drug de­vel­op­ment and fos­ter pa­tient well-be­ing. Stay­ing true to the Japan­ese con­cept of IKI­GAI – help­ing in­di­vid­u­als live life to the fullest – re­mains CMIC’s most im­por­tant core val­ue.

In­ter­view­er:

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•  John Car­roll, Founder & Ed­i­tor, End­points News

In­ter­vie­wees:

•  Kazuo Naka­mu­ra, Ph.D. – Founder & CEO, CMIC Group

CMIC’s Site Man­age­ment Or­ga­ni­za­tion (SMO)

End­points: Can you de­scribe the range of clin­i­cal tri­al sup­port ser­vices that CMIC Group of­fers and how these ser­vices ben­e­fit clin­i­cal tri­al spon­sors?

Kazuo Naka­mu­ra: CMIC Group is APAC’s lead­ing clin­i­cal CRO. We are al­so Japan’s first SMO with over 25 years of ex­pe­ri­ence ac­cel­er­at­ing clin­i­cal tri­als. We of­fer com­pre­hen­sive sup­port to spon­sors, fa­cil­i­tat­ing col­lab­o­ra­tion be­tween phar­ma­ceu­ti­cal com­pa­nies, CROs, and Japan­ese med­ical in­sti­tu­tions. As an SMO, we co­or­di­nate clin­i­cal tri­al lo­gis­tics, in­clud­ing fea­si­bil­i­ty sur­veys that lever­age our med­ical in­sti­tu­tion net­work, con­tract pro­ce­dures, and clin­i­cal staff sup­port. We al­so over­see In­sti­tu­tion­al Re­view Boards (IRBs) and es­sen­tial tri­al doc­u­ments. In Japan, where tri­al agree­ments are be­tween spon­sors and med­ical in­sti­tu­tions, CMIC’s team of Clin­i­cal Re­search Co­or­di­na­tors (CRCs) and Site Man­age­ment As­so­ciates (SMAs) en­sures tri­als are con­duct­ed ef­fi­cient­ly and to a high stan­dard.

CRCs im­prove the qual­i­ty of clin­i­cal tri­als by man­ag­ing key ar­eas such as pa­tient el­i­gi­bil­i­ty, in­formed con­sent sup­port, hos­pi­tal vis­its, test­ing sched­ules and oth­er clin­i­cal tri­al ma­te­ri­als such as prepar­ing Case Re­port Forms (CRFs). To fa­cil­i­tate smooth clin­i­cal tri­als, they pro­vide ad­di­tion­al sup­port to Clin­i­cal Re­search As­so­ciates (CRAs) and as­sist med­ical in­sti­tu­tions with au­dits/reg­u­la­to­ry in­spec­tions.

SMAs are re­spon­si­ble for a wide range of ex­ter­nal re­la­tions and man­age­ment tasks to sup­port the med­ical in­sti­tu­tions on a dai­ly ba­sis. This in­cludes con­duct­ing fea­si­bil­i­ty stud­ies and site prepa­ra­tion for clin­i­cal tri­als, han­dling in­voic­es and doc­u­ment cre­ation, pro­vid­ing sup­port for IRB sub­mis­sions and re­views, and as­sist­ing with au­dits and reg­u­la­to­ry in­spec­tions.

End­points: How does CMIC Group en­sure suc­cess­ful pa­tient en­gage­ment and re­ten­tion in clin­i­cal tri­als through its unique SMO ser­vices?

Kazuo Naka­mu­ra: CMIC Group en­sures suc­cess­ful pa­tient en­gage­ment and re­ten­tion through its SMO ser­vices by guid­ing spon­sors to high-qual­i­ty tri­al sites and con­duct­ing fea­si­bil­i­ty stud­ies to en­sure suc­cess in the clin­i­cal set­ting. Our CRCs main­tain dai­ly com­mu­ni­ca­tion with sites, ad­dress­ing con­cerns and re­duc­ing dropout rates. We lever­age a na­tion­wide net­work of SMO-af­fil­i­at­ed sites and part­ner com­pa­nies, stream­lin­ing pa­tient re­fer­rals and us­ing tar­get­ed re­cruit­ment strate­gies. CMIC al­so part­ners with pa­tient ad­vo­ca­cy groups for out­reach and ed­u­ca­tion. In a NASH tri­al, we swift­ly en­rolled 2,000 pa­tients through ad­vo­ca­cy and ad­ver­tis­ing, while COVID-19 vac­cine tri­als ex­ceed­ed the 1000-pa­tient tar­get by col­lab­o­rat­ing with 13 ad­vo­ca­cy groups, en­hanc­ing re­cruit­ment and over­all da­ta qual­i­ty.

End­points: What ad­van­tages do CMIC Group’s ex­ten­sive net­work and ex­pe­ri­ence in di­verse ther­a­peu­tic ar­eas of­fer to glob­al clin­i­cal tri­al spon­sors?

Kazuo Naka­mu­ra: CMIC Group’s strength lies in its vast net­work of 4,000 med­ical in­sti­tu­tions, deep ex­per­tise, and com­pre­hen­sive data­base, en­abling us to rec­om­mend the most suit­able sites for each ther­a­peu­tic area. We of­fer unique pa­tient re­cruit­ment strate­gies and call cen­ter ser­vices to meet di­verse spon­sor needs across var­i­ous dis­ease ar­eas. Col­lab­o­rat­ing with both glob­al and lo­cal phar­ma­ceu­ti­cal com­pa­nies, we help nav­i­gate dif­fer­ences be­tween Japan­ese and glob­al guide­lines. By con­nect­ing spon­sors with ap­pro­pri­ate med­ical in­sti­tu­tions and man­ag­ing time-con­sum­ing tasks like IRB sub­mis­sions, CMIC’s SMO ser­vices are cru­cial in sup­port­ing CROs and spon­sors ef­fi­cient­ly, es­pe­cial­ly at larg­er clin­i­cal sites with heav­ier work­loads.

Dig­i­tal Health in Japan

End­points: As a com­pa­ny heav­i­ly in­vest­ed in dig­i­tal health, how is CMIC Group lever­ag­ing dig­i­tal tech­nol­o­gy to en­hance its pa­tient-cen­tric so­lu­tions for cus­tomers?

Kazuo Naka­mu­ra: CMIC Group lever­ages dig­i­tal health through its pa­tient-cen­tric plat­forms, har­mo and nanacara.

First­ly, har­mo is a Pa­tient Health Record (PHR) plat­form that in­te­grates with Japan’s My Num­ber Por­tal, phar­ma­cy and hos­pi­tals – au­to­mat­i­cal­ly up­dat­ing med­ical records and elim­i­nat­ing man­u­al in­put. Mean­while, nanacara, ini­tial­ly fo­cused on epilep­sy, helps pa­tients and care­givers man­age seizures and med­ica­tion, while pro­vid­ing tools to mon­i­tor dai­ly pa­tient sta­tus and im­prove clin­i­cal de­ci­sion mak­ing.

These plat­forms en­hance clin­i­cal tri­als by im­prov­ing pa­tient re­cruit­ment, boost­ing en­gage­ment with in­ter­ac­tive fea­tures, and en­rich­ing da­ta qual­i­ty. By stream­lin­ing pa­tient mon­i­tor­ing and da­ta col­lec­tion, har­mo and nanacara make tri­als more ef­fi­cient and pa­tient-friend­ly.

End­points: How is CMIC Group plan­ning to ex­pand the use of in­no­v­a­tive tech­nolo­gies to fur­ther sup­port pa­tient-cen­tric­i­ty and di­ver­si­ty in 2025?

Kazuo Naka­mu­ra: In 2025, CMIC Group plans to ex­pand har­mo – con­nect­ing hos­pi­tals, phar­ma­cies, and pa­tients – to ad­dress op­er­a­tional chal­lenges in health­care. Along with ex­ist­ing in­te­gra­tion ef­forts with nan­cara, har­mo will in­te­grate with plat­forms like ther­a­peu­tic sup­port apps, life in­sur­ance sys­tems, fleet man­age­ment and pub­lic health ser­vices, cre­at­ing syn­er­gies across dif­fer­ent sec­tors. Ad­di­tion­al­ly, nanacara, ini­tial­ly fo­cused on epilep­sy, will ex­pand in­to de­men­tia care in Japan and oth­er Asian coun­tries. By col­lab­o­rat­ing with phar­ma­ceu­ti­cal com­pa­nies to ad­dress un­met med­ical needs, CMIC aims to ex­tend nanacara to oth­er dis­ease ar­eas, fur­ther sup­port­ing pa­tient-cen­tric care and di­ver­si­ty.

Lead­er­ship and IKI­GAI

End­points: How does CMIC Group bal­ance fos­ter­ing in­no­va­tion with main­tain­ing a fo­cus on the core val­ue of IKI­GAI: “liv­ing life to the fullest”?

Kazuo Naka­mu­ra: As ref­er­enced in last year’s ar­ti­cle, IKI­GAI, a Japan­ese con­cept of liv­ing life to the fullest. Re­search com­ing out of Har­vard has shown that IKI­GAI prin­ci­ples are linked to im­proved health out­comes like op­ti­mal blood pres­sure, cho­les­terol and blood sug­ar. This is part­ly due to the pos­i­tive im­pact of strong in­ter­per­son­al re­la­tion­ships. CMIC Group em­braces IKI­GAI as a core val­ue, bal­anc­ing it with in­no­va­tion to fo­cus on holis­tic well-be­ing and longevi­ty. While tra­di­tion­al phar­ma­ceu­ti­cals treat and pre­vent dis­eases, IKI­GAI em­pha­sizes a holis­tic de­sire to live well. As Japan faces an ag­ing so­ci­ety with a low birth rate, the na­tion is pi­o­neer­ing ef­forts to bal­ance these chal­lenges, which is re­flect­ed in its ad­vanced health­care mod­el. CMIC aims to in­te­grate IKI­GAI in­to its phar­ma­ceu­ti­cal val­ue chain. At the 30th DIA An­nu­al Meet­ing in Japan – where I will be the chair­per­son –  CMIC will ex­plore how IKI­GAI can ex­pand glob­al­ly, help­ing peo­ple live more ful­fill­ing lives.

End­points: Can you pro­vide ex­am­ples of how CMIC Group’s lead­er­ship has suc­cess­ful­ly in­te­grat­ed IKI­GAI in­to its in­no­v­a­tive projects?

Kazuo Naka­mu­ra: IKI­GAI is cen­tral to our dig­i­tal health ini­tia­tives, which go be­yond treat­ment to sup­port well-be­ing by en­abling in­di­vid­u­als to pur­sue hob­bies and pas­sions de­spite phys­i­cal lim­i­ta­tions. For ex­am­ple, a pas­sion­ate golfer with a heart con­di­tion can use dig­i­tal tools such as health pa­ra­me­ter mon­i­tors and dig­i­tal ther­a­peu­tics, in or­der to con­tin­ue en­joy­ing the sport with peace of mind. As AI and dig­i­tal­iza­tion evolve, da­ta will trans­form in­to ac­tion­able in­sights, em­pow­er­ing peo­ple to fol­low their IKI­GAI even with health chal­lenges. While mea­sur­ing IKI­GAI through dig­i­tal tools is still emerg­ing, these tech­nolo­gies in­creas­ing­ly help peo­ple live fuller, more ful­fill­ing lives. Em­brac­ing this shift is the health­i­est and smartest way for­ward.

Learn more about CMIC Group’s so­lu­tions here.