Aus­tralia, home to a world-class ear­ly phase clin­i­cal tri­al ecosys­tem

About Avance Clin­i­cal – the Aus­tralian CRO for Biotechs and 2020 win­ner of the Frost & Sul­li­van “Asia-Pa­cif­ic CRO Mar­ket Lead­er­ship Award”

Asia-Pa­cif­ic CRO Mar­ket Lead­er­ship Award, 2020

Avance Clin­i­cal is an Aus­tralian owned Con­tract Re­search Or­gan­i­sa­tion that has been pro­vid­ing high-qual­i­ty clin­i­cal re­search ser­vices fit for glob­al reg­u­la­to­ry stan­dards to the lo­cal and in­ter­na­tion­al drug de­vel­op­ment in­dus­try for 20 years. Avance spe­cialis­es in sup­port­ing biotech com­pa­nies with their ear­ly phase clin­i­cal tri­als lever­ag­ing the world-class ear­ly phase clin­i­cal tri­als ecosys­tem in Aus­tralia.

Avance Clin­i­cal is able to de­liv­er great val­ue to biotech clients through deep ex­pe­ri­ence with the ethics and reg­u­la­to­ry process, es­tab­lished re­la­tion­ships with all of the ear­ly phase tri­al sites and adop­tion of tech­nolo­gies such as Medrio’s in­te­grat­ed eClin­i­cal so­lu­tions.

Reg­is­ter for our next we­bi­nar about con­duct­ing tri­als in Aus­tralia here.

Un­der six-week ap­proval times. No IND re­quired. Ded­i­cat­ed ear­ly phase site net­work.

Aus­tralia is a well-es­tab­lished and in­creas­ing­ly pre­ferred glob­al des­ti­na­tion for ear­ly phase clin­i­cal tri­als. With more than two decades de­liv­er­ing ear­ly phase tri­als, Aus­tralia’s proven spe­cial­ist ecosys­tem at­tracts biotechs want­i­ng rapid drug de­vel­op­ment so­lu­tions with at­trac­tive re­bates that bring down al­ready com­pet­i­tive clin­i­cal tri­al costs. Aus­tralia’s ef­fec­tive man­age­ment of the COVID-19 pan­dem­ic makes it even more at­trac­tive for spon­sors want­i­ng to mit­i­gate against cost­ly de­lays in their drug de­vel­op­ment pro­grams.

The pil­lars of this world class ear­ly phase clin­i­cal tri­al ecosys­tem are the stream­lined ethics and reg­u­la­to­ry process and ac­cess to high qual­i­ty pri­vate fa­cil­i­ties that spe­cial­ize in the con­duct of both Phase 1 and Phase 2 tri­als in healthy and pa­tient pop­u­la­tions. Im­por­tant­ly dur­ing the COVID-19 cri­sis that has closed fa­cil­i­ties around the globe, 100% of Aus­tralia’s Phase 1 Units have re­mained open al­low­ing for tri­al con­ti­nu­ity and on­go­ing drug de­vel­op­ment ac­tiv­i­ties. This world-class ear­ly phase clin­i­cal tri­al ecosys­tem is un­der­pinned by the fi­nan­cial at­trac­tive­ness of the Aus­tralian Gov­ern­ment’s R&D re­bate which of­fers a re­bate of up to 43.5% on clin­i­cal tri­al spend in Aus­tralia.

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Stream­lined Ethics and Reg­u­la­to­ry Process

The Aus­tralian eth­i­cal and reg­u­la­to­ry re­view process is the fastest in the world for un­der­tak­ing ear­ly phase clin­i­cal tri­als. The Aus­tralian reg­u­la­to­ry body for clin­i­cal tri­als, the Ther­a­peu­tic Goods Ad­min­is­tra­tion (‘TGA’), of­fers two schemes for con­duct­ing clin­i­cal tri­als in Aus­tralia, name­ly the Clin­i­cal Tri­al No­ti­fi­ca­tion (CTN) Scheme and Clin­i­cal Tri­al Ex­emp­tion (CTX) Scheme. Most clin­i­cal tri­als ini­ti­at­ed in Aus­tralia are done so un­der the CTN Scheme. The CTN Scheme in­volves a sim­ple no­ti­fi­ca­tion process fol­low­ing ethics ap­proval for the study. It is im­por­tant to note that an ac­tive IND is not re­quired to ini­ti­ate tri­als in Aus­tralia un­der the CTN or CTX Scheme. Avance Clin­i­cal CEO, Yvonne Lunger­shausen says “that the ma­jor­i­ty of Avance Clin­i­cal’s clients are over­seas biotechs look­ing to de­vel­op their prod­ucts for in­ter­na­tion­al mar­kets and while we rec­om­mend to our clients that they are in ac­tive dis­cus­sions with the reg­u­la­tors it is not re­quired for an ac­tive IND to be in place with the FDA pri­or to ini­ti­at­ing tri­als in Aus­tralia.”

The sci­en­tif­ic and eth­i­cal re­view for clin­i­cal tri­als in Aus­tralia is man­aged by the Hu­man Re­search Ethics Com­mit­tee (HREC). Study doc­u­men­ta­tion is sub­mit­ted elec­tron­i­cal­ly via ePro­to­col pri­or to an HREC meet­ing. Due to the stream­lined reg­u­la­to­ry and eth­i­cal re­view process Avance Clin­i­cal can achieve a Site Ini­ti­a­tion Vis­it (SIV) and com­mence a study with­in 5 – 6 weeks of sub­mis­sion to the HREC.

Lead­ing the way with high-qual­i­ty eth­i­cal re­view in strict com­pli­ance with both in­ter­na­tion­al and lo­cal Aus­tralian clin­i­cal tri­al guide­lines, Bell­ber­ry Lim­it­ed is a na­tion­al, pri­vate not-for-prof­it or­gan­i­sa­tion pro­vid­ing stream­lined sci­en­tif­ic and eth­i­cal re­view of hu­man re­search projects across Aus­tralia. Bell­ber­ry is Aus­tralia’s largest in­de­pen­dent re­view­er of hu­man re­search stud­ies pro­vid­ing ser­vices to al­most a third of clin­i­cal tri­als con­duct­ed in Aus­tralia. Along with the qual­i­ty of sci­en­tif­ic and eth­i­cal re­view, time­li­ness is in­te­gral in sup­port­ing re­search, par­tic­u­lar­ly in ear­ly phase stud­ies. With twelve com­mit­tees, Bell­ber­ry has an av­er­age turn­around time of about 20 work­ing days from sub­mis­sion of ap­pli­ca­tion to re­view de­ci­sion.

Kylie Spros­ton, CEO, Bell­ber­ry Lim­it­ed

“Con­duct­ing re­search on hu­mans car­ries risk. We have a pub­lic re­spon­si­bil­i­ty to en­sure that all in­ter­ac­tions un­der­tak­en dur­ing re­search are sci­en­tif­i­cal­ly and eth­i­cal­ly ac­cept­able. The pro­vi­sion of re­view by a Hu­man Re­search Ethics Com­mit­tee is a vi­tal part of en­sur­ing the ap­pro­pri­ate­ness of any re­search. As a coun­try where world class re­search takes place, Aus­tralia recog­nis­es the val­ue and im­por­tance of this re­view,” ex­plained Kylie Spros­ton, Bell­ber­ry Lim­it­ed CEO.

This year, Bell­ber­ry gained in­ter­na­tion­al recog­ni­tion for the qual­i­ty of its work by be­com­ing the first Aus­tralian or­gan­i­sa­tion to achieve ac­cred­i­ta­tion for ex­cel­lence and eth­i­cal­ly sound process­es in run­ning HRECs from the US-based As­so­ci­a­tion for the Ac­cred­i­ta­tion of Hu­man Re­search Pro­tec­tion Pro­grams (AAHRPP), re-en­forc­ing Aus­tralia’s po­si­tion as the high qual­i­ty ear­ly phase clin­i­cal des­ti­na­tion.

“High re­search and qual­i­ty stan­dards (es­pe­cial­ly ear­ly phase ca­pa­bil­i­ty), com­pa­ra­ble costs, time­ly tri­al ap­proval and re­li­able pa­tient re­cruit­ment make Aus­tralia an at­trac­tive des­ti­na­tion to con­duct clin­i­cal tri­als.” No­var­tis – Clin­i­cal tri­al Ca­pa­bil­i­ty Re­port

“In ear­ly phase clin­i­cal tri­als Aus­tralia is 28 per cent cheap­er than the US be­fore tax in­cen­tives, and 60 per cent cheap­er af­ter tax in­cen­tives.” Aus­tralia: Pre­ferred Des­ti­na­tion for Ear­ly Phase Clin­i­cal Tri­als. Frost & Sul­li­van

Medrio’s eClin­i­cal So­lu­tions Fa­cil­i­tates Rapid Start-up

Avance Clin­i­cal is able to de­liv­er sig­nif­i­cant val­ue to biotech clients and cap­i­tal­ize on the stream­lined ethics and reg­u­la­to­ry process through part­ner­ing with pro­gres­sive tech­nol­o­gy com­pa­nies like Medrio. Medrio is a trust­ed eClin­i­cal provider of­fer­ing an Elec­tron­ic Da­ta Cap­ture (EDC) plat­form with in­te­grat­ed ePRO, eCon­sent, and Di­rect Cap­ture.

Mike Novot­ny, CEO, Medrio, Inc.

Medrio CEO, Mike Novot­ny, com­ment­ed that “Medrio has sup­port­ed nu­mer­ous study starts in Aus­tralia, over 150 with Avance Clin­i­cal alone, and we’re al­ways im­pressed with the speed of their time­lines.”

The team of in-house Clin­i­cal Pro­gram­mers at Avance Clin­i­cal work di­rect­ly in the Medrio eClin­i­cal plat­form to de­liv­er a study ready, in­te­grat­ed EDC plat­form in par­al­lel to the ethics re­view process. The out­come is that study start-up from fi­nal pro­to­col to first pa­tient en­rolled can be achieved with­in 6 weeks. Aus­tralia’s stream­lined ethics and reg­u­la­to­ry process and Medrio’s eClin­i­cal plat­form is a per­fect com­bi­na­tion for ac­cel­er­at­ing study start-up, a crit­i­cal com­po­nent to ear­ly phase tri­als.

Lis­ten to Avance Clin­i­cal CEO Yvonne Lunger­shausen and San­drien Louwaars, Di­rec­tor of Busi­ness De­vel­op­ment Op­er­a­tions, on Medrio’s new pod­cast se­ries Tri­al Talks.

Yvonne Lunger­shausen, CEO, Avance Clin­i­cal

Aus­tralia’s over two decades of ear­ly phase re­search ex­per­tise was kick-start­ed by Avance Clin­i­cal CEO Yvonne Lunger­shausen.

In 1999 Yvonne along with col­league Jane Kel­ly, CMAX Clin­i­cal Re­search CEO, con­duct­ed the first Phase 1 first-in-hu­man study of a new chem­i­cal en­ti­ty in Aus­tralia. Their knowl­edge and process­es went in to set­ting-up what are now the lead­ing Phase I fa­cil­i­ties in Aus­tralia.

The top rea­sons for se­lect­ing Aus­tralia are:

1. The Gov­ern­ment R&D grant means up to 43.5% re­bate on clin­i­cal tri­al spend
2. Tele­health piv­ot dur­ing COVID-19 pan­dem­ic – speed and con­ti­nu­ity
3. Site Ini­ti­a­tion Vis­it (SIV) and Study Start achieved in 5 – 6 weeks
4. No IND re­quired for clin­i­cal tri­als
5. Full GMP ma­te­r­i­al is not man­dat­ed for Phase I clin­i­cal tri­als
6. Es­tab­lished clin­i­cal tri­al en­vi­ron­ment with world-class In­ves­ti­ga­tors and sites
7. Es­tab­lished healthy sub­ject data­bas­es and spe­cialised pa­tient pop­u­la­tions
8. Five in­de­pen­dent Phase 1 fa­cil­i­ties across Aus­tralia in­clud­ing hos­pi­tal-based units for crit­i­cal care
9. Ma­jor hos­pi­tals with world class in­fra­struc­tures and ded­i­cat­ed Clin­i­cal Tri­al Units with a long track-record in FDA com­pli­ant re­search
10. Sea­son­al stud­ies: North­ern hemi­sphere Spon­sors can con­duct their stud­ies year-round by tak­ing ad­van­tage of Aus­tralia’s counter-flu and al­ler­gy sea­sons

“Aus­tralia is home to some of the world’s lead­ing sci­en­tists, physi­cians and health­care pro­fes­sion­als. It boasts world-class med­ical re­search and health­care in­fra­struc­ture, a sta­ble so­cioe­co­nom­ic en­vi­ron­ment, an eth­ni­cal­ly di­verse pop­u­la­tion and a strong in­tel­lec­tu­al prop­er­ty regime.

An ef­fi­cient reg­u­la­to­ry sys­tem, in­clud­ing a rapid clin­i­cal tri­al ap­proval sys­tem, well-es­tab­lished clin­i­cal tri­al in­fra­struc­ture, ex­pe­ri­enced and well-qual­i­fied per­son­nel and glob­al­ly com­pet­i­tive tax in­cen­tives for re­search and de­vel­op­ment (R&D) in­vest­ment, all help make Aus­tralia a lead­ing des­ti­na­tion …” Clin­i­cal tri­al Ca­pa­bil­i­ty Re­port

Spot­light on Aus­tralia’s World Class Ear­ly Phase Tri­al Sites (al­pha­bet­i­cal or­der)

The net­work of pri­vate clin­i­cal tri­al sites are the lifeblood of Aus­tralia’s world-class ear­ly phase ecosys­tem. With the abil­i­ty to con­duct tri­als from small first in hu­man, healthy vol­un­teer tri­als to con­duct­ing com­plex mul­ti-cen­tre phase 1 and phase 2 pa­tient tri­als in­volv­ing both small mol­e­cules and bi­o­log­i­cals these spe­cial­ist Aus­tralian sites cater for the full spec­trum of ear­ly phase tri­als. Im­por­tant­ly dur­ing the COVID-19 cri­sis all of these sites have re­mained open to en­sure clin­i­cal tri­al con­ti­nu­ity.

Avance Clin­i­cal has great re­la­tion­ships with all of these high-qual­i­ty ear­ly phase sites con­duct­ing stud­ies across the spec­trum of healthy vol­un­teer and pa­tient-based Phase 1 and Phase 2 tri­als. In com­bi­na­tion with the stream­lined reg­u­la­to­ry re­view process pro­vid­ed by the Bell­ber­ry HREC, the CTN Scheme ad­min­is­tered by the TGA and the Aus­tralian Gov­ern­ment’s R & D re­bate of up to 43.5% on clin­i­cal tri­al spend, Aus­tralia re­mains the pre­mier des­ti­na­tion glob­al­ly for ear­ly phase clin­i­cal tri­als.

CMAX, Ade­laide, South Aus­tralia

CMAX Clin­i­cal Re­search

Jane Kel­ly, CEO, CMAX Clin­i­cal Re­search

CMAX is Aus­tralia’s longest es­tab­lished fa­cil­i­ty for clin­i­cal tri­als, de­liv­er­ing high qual­i­ty clin­i­cal tri­als for their in­ter­na­tion­al spon­sors. Cen­tral­ly po­si­tioned in the heart of Ade­laide, CMAX is lo­cat­ed op­po­site the Roy­al Ade­laide Hos­pi­tal and ad­ja­cent to the in­no­v­a­tive Bio­Med City precinct. For the past 26 years CMAX has been con­duct­ing world-lead­ing re­search for lo­cal and in­ter­na­tion­al clients, spe­cial­is­ing in a range of ear­ly-phase tri­als and first-time-in-hu­man stud­ies. Their ro­bust qual­i­ty man­age­ment sys­tems pro­vide spon­sors with re­as­sur­ance that tri­al da­ta will be ac­cept­able to the FDA and oth­er reg­u­la­to­ry agen­cies and have a long his­to­ry of sup­port­ing in­ter­na­tion­al spon­sors through this phase. CMAX CEO, Jane Kel­ly ad­vised that “We’ve nev­er seen more de­mand for our ear­ly phase tri­als, so it would seem that there is good recog­ni­tion of the ben­e­fits of com­plet­ing this work down un­der! In fact, a good por­tion of our work comes via word-of-mouth re­fer­rals, par­tic­u­lar­ly from with­in the dy­nam­ic US biotech sec­tor, which we see as ev­i­dence that our ear­ly phase ad­van­tage is re­al.”

Lin­ear, Perth, West­ern Aus­tralia

Lin­ear Clin­i­cal Re­search

Dou­gal Thring, Head of Clin­i­cal So­lu­tions, Lin­ear

Lin­ear is a tech-cen­tric, so­lu­tions fo­cused clin­i­cal re­search group, spe­cial­is­ing in first-in-hu­man and oth­er clin­i­cal phar­ma­col­o­gy tri­als, first-in-hu­man on­col­o­gy tri­als, and first-in-pa­tient tri­als, en­abled by their strate­gic lo­ca­tion with­in the QEII Med­ical Cen­tre in Perth, West­ern Aus­tralia. It is co-lo­cat­ed with a 600-bed ter­tiary adult hos­pi­tal, 738-bed pri­vate hos­pi­tal, state can­cer cen­tre, 400-bed pae­di­atric hos­pi­tal, nu­mer­ous ther­a­peu­tic spe­cif­ic re­search in­sti­tutes, and the Uni­ver­si­ty of West­ern Aus­tralia Med­ical School. Dou­gal Thring, Head of Clin­i­cal So­lu­tions at Lin­ear com­ment­ed that “with ex­ten­sive ex­per­tise across the coun­try, Aus­tralia is able to ex­e­cute all as­pects of ear­ly phase tri­als, low sam­ple trans­port risks, and en­sur­ing the high­est qual­i­ty out­put of da­ta, ac­cept­ed by glob­al reg­u­la­tors.”

Nu­cle­us Net­work, Mel­bourne and Bris­bane

Nu­cle­us Net­work

Jef­fery Wong, Di­rec­tor of Busi­ness De­vel­op­ment, Nu­cle­us Net­work

With 150 phase I beds co-lo­cat­ed with­in ma­jor Hos­pi­tals in Mel­bourne and Bris­bane, Nu­cle­us Net­work is Aus­tralia’s largest Phase 1 clin­i­cal tri­als spe­cial­ist. Nu­cle­us Net­work’s clin­ics are lo­cat­ed with­in two of Aus­tralia’s most pres­ti­gious teach­ing hos­pi­tals – the Al­fred Hos­pi­tal in Mel­bourne, and the Bris­bane Hos­pi­tal in Bris­bane. These ma­jor city lo­ca­tions al­so pro­vide Nu­cle­us Net­work with ac­cess to over 7.5 mil­lion peo­ple for healthy vol­un­teer and pa­tient clin­i­cal tri­als. Nu­cle­us Net­work has spe­cial­ized phys­i­cal in­fra­struc­ture and spe­cial­ized re­cruit­ment strate­gies to de­liv­er com­plex first in hu­man clin­i­cal tri­als to large vol­ume scale biosim­i­lar and through to the man­age­ment of se­vere­ly im­paired re­nal pa­tients across their dif­fer­ent fa­cil­i­ties. These are some of the rea­sons Nu­cle­us Net­work was en­trust­ed with the first COVID-19 vac­cine tri­al in the south­ern hemi­sphere. Jef­fery Wong, Di­rec­tor of Busi­ness De­vel­op­ment for Nu­cle­us Net­work stat­ed that “with over 15 years’ ex­pe­ri­ence in con­duct­ing ear­ly phase clin­i­cal tri­als for US, Asian and Eu­ro­pean Biotech­nol­o­gy and Phar­ma­ceu­ti­cal com­pa­nies, Nu­cle­us Net­work un­der­stand the evolv­ing land­scape of drug de­vel­op­ment. Ac­cess to pa­tients, short­ened re­cruit­ment time­lines and the evo­lu­tion of phar­ma­co­dy­nam­ic bio­mark­ers are key fun­da­men­tals un­der­pin­ning Nu­cle­us Net­works mul­ti-site to ap­proach to phase I clin­i­cal tri­als.”

Para­tus Clin­i­cal, lo­ca­tions across New South Wales and the Aus­tralian Cap­i­tal Ter­ri­to­ry

Para­tus Clin­i­cal

Matt Cla­cy, Chief Com­mer­cial Of­fi­cer, Para­tus Clin­i­cal

Para­tus Clin­i­cal op­er­ates three pri­vate clin­ics in the high pop­u­la­tion ar­eas of the east coast of Aus­tralia with a fourth clin­ic to open in Q3, 2020. Para­tus Clin­i­cal has been es­tab­lished to meet an in­creas­ing de­mand for clin­i­cal re­search sites in Aus­tralia with an em­pha­sis on sup­port­ing both healthy vol­un­teer and pa­tient based stud­ies. In par­tic­u­lar they have con­duct­ed 17 ear­ly (Phase I-II) stud­ies in both pa­tients and healthy sub­jects for new med­i­cines and vac­cines. “We have built our suc­cess on our unique pa­tient re­cruit­ment ca­pa­bil­i­ty and large pa­tient data­base which al­lows us to rapid­ly re­cruit and de­liv­er large scale tri­als in com­pet­i­tive time­frames” said Matt Cla­cy, Chief Com­mer­cial Of­fi­cer for Para­tus Clin­i­cal.

PARC Clin­i­cal Re­search, Ade­laide, South Aus­tralia

PARC Clin­i­cal Re­search

Pro­fes­sor Guy Lud­brook, Di­rec­tor of PARC Clin­i­cal Re­search

PARC Clin­i­cal Re­search is a 12-bed clin­i­cal tri­als unit lo­cat­ed with­in a ma­jor ter­tiary hos­pi­tal, the Roy­al Ade­laide Hos­pi­tal, with an ex­ten­sive track record in con­duct­ing Phase 1-3 high qual­i­ty clin­i­cal tri­als across most med­ical and sur­gi­cal spe­cial­i­ties. It has staff and In­ten­sive Care-lev­el fa­cil­i­ties able to man­age a range of clin­i­cal tri­als, from low acu­ity tri­als through to those re­quir­ing in­va­sive com­plex mon­i­tor­ing and high-acu­ity care. Pro­fes­sor Guy Lud­brook, Di­rec­tor of PARC Clin­i­cal Re­search stat­ed that “PARC recog­nis­es the im­por­tance of hav­ing a strate­gic de­vel­op­ment plan in place, from the time of first-in-hu­man tri­als, which aligns with cur­rent and fu­ture clin­i­cal need for a ther­a­peu­tic prod­uct. To that end, it has ex­ten­sive links to re­searchers, clin­i­cians, health and aca­d­e­m­ic cen­tres, and health ju­ris­dic­tions, across a broad range of med­ical dis­ci­plines. This en­sures that every tri­al is de­signed to max­imise the op­por­tu­ni­ties to ob­tain the knowl­edge es­sen­tial to de­ter­mine the op­ti­mal way for­ward for prod­uct de­vel­op­ment.”

Sci­en­tia Clin­i­cal Re­search, Syd­ney, New South Wales

Lisa Nel­son, CEO, Sci­en­tia Clin­i­cal Re­search

Sci­en­tia Clin­i­cal Re­search

Sci­en­tia Clin­i­cal Re­search has world-class clin­i­cal tri­al ex­per­tise and state of the art fa­cil­i­ties en­abling them to con­duct a wide range of clin­i­cal tri­als, with a fo­cus on ear­ly stage clin­i­cal re­search. Lo­cat­ed in the Bright Al­liance Build­ing with the Nelune Com­pre­hen­sive Can­cer Cen­tre and ser­vices of the Syd­ney Chil­dren’s Hos­pi­tal. The fa­cil­i­ty is al­so co-lo­cat­ed in a ma­jor re­search precinct with Prince of Wales Hos­pi­tal, Roy­al Hos­pi­tal for Women, UNSW Syd­ney and the Lowy Can­cer Re­search Cen­tre. “Util­is­ing the ca­pa­bil­i­ties of our state of the art fa­cil­i­ties, our mis­sion is to sup­port the con­tin­u­ous de­vel­op­ment of new med­i­cines to help to im­prove health and find bet­ter treat­ment op­tions for pa­tients,” said Sci­en­tia Clin­i­cal Re­search CEO, Lisa Nel­son.

Uni­ver­si­ty of the Sun­shine Coast (USC) Clin­i­cal Tri­als Aus­tralia

Lu­cas Litewka, Di­rec­tor, USC Clin­i­cal Tri­als

USC Clin­i­cal Tri­als Aus­tralia was es­tab­lished in 2015 with a goal to bridge the gap be­tween in­no­v­a­tive med­i­cines and com­mu­ni­ty.

The cen­tre per­forms clin­i­cal tri­als in chron­ic dis­eases, vac­cines, can­cer, healthy vol­un­teers, and med­ical de­vices across all phas­es of de­vel­op­ment.

Lu­cas Litewka, Di­rec­tor, USC Clin­i­cal Tri­als states, “Our net­work of sites work along­side pri­ma­ry and spe­cial­ist care in­ves­ti­ga­tors to ac­cess a new pop­u­la­tion of over 850,000 pa­tients. Com­mu­ni­ty en­gage­ment forms the back­bone of our re­cruit­ment strate­gies, a crit­i­cal suc­cess fac­tor in en­sur­ing we can meet rapid en­rol­ment goals in healthy vol­un­teer and chron­ic dis­ease stud­ies.”