How In­no­v­a­tive Tech­nolo­gies and a Ded­i­cat­ed Site Net­work is Dri­ving Pa­tient Re­cruit­ment for Biotech Clin­i­cal Tri­als in Aus­tralia

Aus­tralia’s CRO for biotechs, Avance Clin­i­cal, deep dives in­to the pa­tient re­cruit­ment land­scape iden­ti­fy­ing the mech­a­nisms and process­es that de­liv­er ex­cep­tion­al pa­tient re­cruit­ment for ear­ly phase tri­als in Aus­tralia.

Avance Clin­i­cal al­so of­fers mod­els for lat­er phase piv­ots to large pa­tient pop­u­la­tions in Cen­tral and East­ern Eu­rope and the US via ex­clu­sive col­lab­o­ra­tions with more than 3,500 sites. Learn more here.

In Aus­tralia, Site Ini­ti­a­tion Vis­it (SIV) and Study Start can be achieved in 5 – 6 Weeks, plus there is up to a 43.5% re­fund on clin­i­cal tri­al spend.

Yvonne Lunger­shausen, CEO, Avance Clin­i­cal

Avance Clin­i­cal is the Aus­tralian owned full-ser­vice biotech CRO that has been pro­vid­ing high-qual­i­ty clin­i­cal re­search ser­vices across all phas­es to the US, APAC, and EU drug de­vel­op­ment in­dus­try for over 20 years.

“Our team has ex­ten­sive ther­a­peu­tic area knowl­edge and ex­per­tise and has con­duct­ed drug tri­als with large mol­e­cules, small mol­e­cules, gene ther­a­pies and de­vices pro­vid­ing high-qual­i­ty clin­i­cal re­search ser­vices fit for glob­al reg­u­la­to­ry stan­dards,” said Yvonne Lunger­shausen, Avance Clin­i­cal’s CEO
“We of­fer end-to-end in-house clin­i­cal re­search ser­vices in­clud­ing drug de­vel­op­ment con­sul­ta­tion, med­ical writ­ing, clin­i­cal project man­age­ment, tri­al mon­i­tor­ing, phar­ma­covig­i­lance, da­ta man­age­ment, sta­tis­ti­cal and phar­ma­co­ki­net­ic ser­vices, CDISC and ex­ter­nal and in­ter­nal au­dit­ing.”

Pa­tient Re­cruit­ment Land­scape

Andy Hu, Cor­po­rate Ac­count Man­ag­er at Phar­ma In­tel­li­gence, In­for­ma

Pa­tient re­cruit­ment suc­cess is fun­da­men­tal to the suc­cess of clin­i­cal tri­als.

More than 50% of Avance Clin­i­cal’s tri­als in­volve pa­tients seek­ing to sup­port the de­vel­op­ment of new ther­a­pies for their con­di­tions. As a re­sult the com­pa­ny has built sig­nif­i­cant ex­per­tise in pa­tient re­cruit­ment across a range of ther­a­peu­tic ar­eas. This in­cludes uti­liz­ing world class mar­ket in­tel­li­gence so­lu­tions, de­vel­op­ment of strong in­ves­ti­ga­tor site re­la­tion­ships and a range of re­cruit­ment ven­dors uti­liz­ing in­no­v­a­tive tech­nolo­gies to in­crease the ac­cu­ra­cy of re­cruit­ment rates and max­imise pa­tient re­cruit­ment dur­ing tri­al con­duct.

Im­por­tant­ly, pa­tient re­cruit­ment costs are cov­ered by the 43.5% re­bate in­cen­tive of­fered by the Aus­tralian Gov­ern­ment.

For ex­am­ple, Andy Hu, Cor­po­rate Ac­count Man­ag­er at Phar­ma In­tel­li­gence, In­for­ma re­port­ed that “ac­cord­ing to Tri­al­trove, Cite­line, from Jan­u­ary 1st, 2010 to De­cem­ber 31st, 2019, Aus­tralian sites re­cruit pa­tients faster for on­col­o­gy tri­als than sites in North Amer­i­ca, Eu­rope and Asia.” As shown in Graph 1 be­low the av­er­age re­cruit­ment du­ra­tion in Aus­tralia is 23.51 months for On­col­o­gy tri­als in Aus­tralia vs 27.81 months and 27.07 months in North Amer­i­ca and Eu­rope re­spec­tive­ly.

Avance Clin­i­cal’s ac­cess to re­cruit­ment bench­mark da­ta uti­liz­ing tech­nol­o­gy such as world lead­ing mar­ket in­tel­li­gence so­lu­tion Tri­al­trove, Cite­line as well as our strong In­ves­ti­ga­tor and site re­la­tion­ships al­low us to ac­cu­rate­ly plan for on time study de­liv­ery.

Avance Clin­i­cal Re­cruit­ment Part­ners

Proven part­ners for this vi­tal ser­vice

Avance Clin­i­cal will rec­om­mend and en­gage a com­pre­hen­sive re­cruit­ment so­lu­tion based on the study de­sign, ther­a­peu­tic area and pa­tient pro­file. Util­is­ing in­no­v­a­tive, world lead­ing tech­nol­o­gy so­lu­tions and sites ded­i­cat­ed to ac­cess­ing pa­tients in spe­cif­ic ther­a­peu­tic ar­eas, pro­vides our clients with com­fort for on-time pa­tient re­cruit­ment.

Some of the ben­e­fits these part­ners of­fer in­clude:

• Stream­lined EC (IRB equiv­a­lent) pa­tient ad­ver­tis­ing and mar­ket­ing ap­proval sub­mis­sion process­es
• Deep ex­pe­ri­ence around EC ad­ver­tis­ing ap­proval process – what is ac­cept­ed
• Ad­her­ence to TGA (FDA equiv­a­lent) ad­ver­tis­ing/pa­tient en­gage­ment reg­u­la­tions
• Com­plete un­der­stand­ing of Aus­tralian pa­tient pri­va­cy and PHI reg­u­la­tions
• Rapid in-house or on­line screen­ing
• Se­cure pa­tient in­for­ma­tion trans­fers and con­nec­tions with sites/Study Co­or­di­na­tors
• Feed­back sys­tems around re­cruit­ment strate­gies

Avance Clin­i­cal part­ners with three broad pa­tient re­cruit­ment part­ner cat­e­gories to en­sure rapid pa­tient re­cruit­ment for tri­als in Aus­tralia:

1. Tech­nol­o­gy-based so­lu­tions
2. Sites with spe­cial­ist ex­per­tise and sys­tems
3. Pa­tient ser­vices that sup­port re­cruit­ment and re­ten­tion

Tech­nol­o­gy-based so­lu­tions:

Dig­i­tal tech­nol­o­gy so­lu­tions can of­fer speed and cost ad­van­tages as well as sig­nif­i­cant­ly de-risk­ing pa­tient re­cruit­ment. Avance Clin­i­cal lever­ages a num­ber of world class tech­nol­o­gy so­lu­tions that sup­port pa­tient re­cruit­ment plan­ning and rapid pa­tient en­rol­ment.

Phar­ma In­tel­li­gence | In­for­ma

Phar­ma In­tel­li­gence | In­for­ma

Phar­ma In­tel­li­gence, In­for­ma is a world lead­ing mar­ket in­tel­li­gence so­lu­tion which pro­vides pre­cise and fo­cused analy­sis for phar­ma­ceu­ti­cal, biotech, medtech, CRO, CD­MO and in­vest­ment and ven­ture cap­i­tal or­ga­ni­za­tions. Avance Clin­i­cal uti­lizes Tri­al­trove and Sitetrove data­bas­es from In­for­ma to ac­cu­rate­ly guide pa­tient re­cruit­ment ac­tiv­i­ties.

• Tri­al­trove is a com­pre­hen­sive, ac­cu­rate and up-to-date source of phar­ma­ceu­ti­cal clin­i­cal tri­als da­ta and al­lows Avance Clin­i­cal ac­cess to pa­tient re­cruit­ment bench­mark da­ta when plan­ning for tri­als.
• Sitetrove pro­vides com­pre­hen­sive da­ta on clin­i­cal tri­als sites and in­ves­ti­ga­tors and al­lows Avance to per­form cus­tomized search­es to:
• Gen­er­ate lists of sites and in­ves­ti­ga­tors with the re­quired ex­pe­ri­ence and qual­i­fi­ca­tions
• Use an­a­lyt­ics to ge­o­graph­i­cal­ly iden­ti­fy in­ves­ti­ga­tor, physi­cians and pa­tient da­ta

Util­is­ing this da­ta from world lead­ing data­bas­es such as Tri­al­trove and Sitetrove al­lows Avance Clin­i­cal to ac­cu­rate­ly plan for and dri­ve rapid pa­tient re­cruit­ment.

Fol­low­ing the study plan­ning phase Avance Clin­i­cal has ac­cess to a num­ber of tech­no­log­i­cal­ly ad­vanced so­lu­tions that fa­cil­i­tate fast pa­tient re­cruit­ment in­clud­ing:

Evri­ma Tech­nolo­gies

Char­lotte Brad­shaw, CEO and Founder, Evri­ma

Evri­ma Tech­nolo­gies

Evri­ma Tech­nolo­gies pro­vides an au­to­mat­ed, da­ta dri­ven ap­proach to pa­tient re­cruit­ment via pre­ci­sion match­ing, un­lock­ing the 99% of po­ten­tial tri­al par­tic­i­pants not ac­ces­si­ble through tra­di­tion­al re­cruit­ment meth­ods. Evri­ma’s in­tel­li­gent plat­form con­nects tri­als to physi­cians at scale and pro­vides re­searchers with qual­i­fied par­tic­i­pants for their tri­als via pre­vi­ous­ly un­der-uti­lized elec­tron­ic med­ical records.

Evri­ma’s CEO and Founder, Char­lotte Brad­shaw stat­ed that “we have over 9 years of ex­ten­sive pa­tient re­cruit­ment ex­pe­ri­ence across a wide range of ther­a­peu­tic ar­eas and have di­rect-to-clin­i­cian and di­rect-to-pa­tient ca­pa­bil­i­ties across Aus­tralia. Giv­en that more than 80% of clin­i­cal tri­als are de­layed due to pa­tient re­cruit­ment chal­lenges, Evri­ma’s core fo­cus is to ac­cel­er­ate re­cruit­ment time­lines and help Spon­sor’s reach crit­i­cal mile­stones rapid­ly.”

Clin­Tri­al Re­fer

Chris­tine Zahren, Busi­ness De­vel­op­ment Man­ag­er, Clin­Tri­al Re­fer

Clin­Tri­al Re­fer

Clin­Tri­al Re­fer is an award-win­ning Aus­tralian dig­i­tal in­no­va­tion de­vel­oped by hema­tol­ogy clin­i­cal re­searchers in Syd­ney to solve the prob­lem of pa­tient re­fer­ral and re­cruit­ment. Now wide­ly used in oth­er ar­eas of med­i­cine in Aus­tralia and over­seas the mo­bile app and web­site plat­form al­lows doc­tors and pa­tients to in­de­pen­dent­ly search for ac­tive­ly re­cruit­ing clin­i­cal tri­als and to ac­cess tri­al site lo­ca­tions and con­tact de­tails in re­al time.

“Clin­Tri­al Re­fer gives every­one ac­cess to clin­i­cal tri­als at their fin­ger­tips wher­ev­er they are – in the clin­ic, by the bed­side or in team meet­ings. Clin­Tri­al Re­fer can be li­censed by any re­search group, hos­pi­tal or net­work to in­crease the vis­i­bil­i­ty of their clin­i­cal tri­als and im­prove re­cruit­ment” said Chris­tine Zahren, Busi­ness De­vel­op­ment Man­ag­er at Clin­Tri­al Re­fer.

Con­tact Avance Clin­i­cal team for more in­for­ma­tion on how to ac­cess these world-lead­ing and tar­get­ed tech­nolo­gies to help dri­ve your pa­tient re­cruit­ment ef­forts.

Sites with spe­cial­ist ex­per­tise and sys­tems – in al­pha­bet­i­cal or­der

In ad­di­tion to world-class re­cruit­ment tech­nolo­gies, Avance Clin­i­cal has ex­cel­lent re­la­tion­ships with a very ex­pe­ri­enced and di­verse ar­ray of clin­i­cal tri­als sites that dri­ve pa­tient re­cruit­ment across a broad range of ther­a­peu­tic ar­eas. These ded­i­cat­ed, pri­vate clin­i­cal tri­al sites are able to draw from dis­tinct ge­o­graph­ic ar­eas and ac­cess pa­tients from around the coun­try. Many of these sites have es­tab­lished ded­i­cat­ed re­cruit­ment ser­vices to sup­port their CRO and Spon­sor clients.

Aus­Tri­als Clin­i­cal Re­search

Dr. Munro Neville, Man­ag­ing Di­rec­tor, Aus­Tri­als

Aus­Tri­als

Aus­Tri­als is a lead­ing gen­er­al med­i­cine clin­i­cal re­search com­pa­ny with mul­ti­ple sites in east­ern Aus­tralia. Un­der a cor­po­rate agree­ment, Aus­Tri­als has ac­cess to the dei­den­ti­fied records from a na­tion­wide net­work of pri­ma­ry care med­ical cen­tres. These cen­tres have world class fa­cil­i­ties that sup­port hun­dreds of in­de­pen­dent Gen­er­al Prac­ti­tion­ers (fam­i­ly doc­tors) and fa­cil­i­tate the re­cruit­ment to clin­i­cal tri­als. Man­ag­ing Di­rec­tor and Study In­ves­ti­ga­tor, Dr Munro Neville, stat­ed that “Aus­Tri­als is cur­rent­ly en­hanc­ing a re­cruit­ment tool en­abling su­pe­ri­or match­ing of these 2 mil­lion pa­tients to avail­able clin­i­cal tri­als”.

Para­tus Clin­i­cal

Matt Cla­cy, Chief Com­mer­cial Of­fi­cer, Para­tus Clin­i­cal

Para­tus Clin­i­cal

Para­tus holis­ti­cal­ly sup­ports pa­tient re­cruit­ment, start­ing with their ded­i­cat­ed Re­search Re­cruit­ment Spe­cial­ists who un­der­stand the en­tire par­tic­i­pant ex­pe­ri­ence in­clud­ing the ill­ness, in­ter­ven­tion and sched­ule of events which as­sists in build­ing strong par­tic­i­pant re­la­tion­ships and re­duc­ing at­tri­tion. They work along­side ex­perts to en­sure every study has a be­spoke plan cre­at­ed, which is dy­nam­i­cal­ly man­aged by the Re­cruit­ment team who dri­ve the re­cruit­ment process to help spon­sors and CROs com­plete their stud­ies quick­er with­out any com­pro­mise on qual­i­ty. Matt Cla­cy, Chief Com­mer­cial Of­fi­cer at Para­tus Clin­i­cal states that “Our clin­ics have on­go­ing re­la­tion­ships with re­fer­ring part­ners and have de­vel­oped cap­ti­vat­ing ad­ver­tise­ments on an ar­ray of plat­forms to reach po­ten­tial par­tic­i­pants. We have al­so built an ex­ten­sive data­base of par­tic­i­pants with an ar­ray of con­di­tions that are in­ter­est­ed and keen to par­tic­i­pate in clin­i­cal tri­als which en­sures greater par­tic­i­pant re­ten­tion and tri­al ef­fi­ca­cy”.

Plexus Re­search

Suhit Anan­tu­la, Founder and CEO, Plexus Re­search

Plexus Re­search – Ade­laide, South Aus­tralia

Plexus Re­search is a com­mu­ni­ty-based drug de­vel­op­ment part­ner with a rich and di­verse Site Man­age­ment Or­gan­i­sa­tion net­work in Aus­tralia with a strong fo­cus on re­cruit­ing pa­tient pop­u­la­tions through GP clin­ics. Through its net­work of clin­ics, com­bined with its da­ta an­a­lyt­ics plat­form, Plexus Re­search pro­vides ac­cess to 100,000 ac­tive pa­tients across a va­ri­ety of de­mo­graph­ics and dis­ease groups. Their net­work of sites are com­mu­ni­ty prac­tices in­clud­ing both gen­er­al and spe­cial­ist prac­tices. Founder & CEO, Suhit Anan­tu­la, states that “this pro­vides ac­cess to a rich data­base of pa­tients, and pa­tient par­tic­i­pa­tion is in­creased due to the vicin­i­ty of sites to pa­tients’ homes and con­ti­nu­ity of care”.

USC Clin­i­cal Tri­als

Lu­cas Litewka, Di­rec­tor, USC Clin­i­cal Tri­als

Uni­ver­si­ty of the Sun­shine Coast (USC) Clin­i­cal Tri­als

USC Clin­i­cal Tri­als com­bines re­fer­rals from a net­work of spe­cial­ists and gen­er­al prac­ti­tion­ers, close col­lab­o­ra­tion with pa­tient ad­vo­ca­cy groups and a data­base of more than 11,000 healthy vol­un­teers to sup­port its re­cruit­ment strate­gies. A key part of their re­cruit­ment strat­e­gy in­volves tar­get­ed so­cial me­dia ad­ver­tise­ments and en­gage­ment with lo­cal me­dia to rapid­ly reach pa­tient pop­u­la­tions. USC Clin­i­cal Tri­als tai­lor their en­gage­ment strat­e­gy to the com­mu­ni­ty which has en­abled re­cruit­ment num­bers to ex­ceed ex­pec­ta­tions across many ther­a­peu­tic ar­eas, with an av­er­age of 55 par­tic­i­pants re­cruit­ed per study over the last 2 years.

Lu­cas Litewka, Di­rec­tor, USC Clin­i­cal Tri­als states “Com­mu­ni­ty en­gage­ment forms the back­bone of our re­cruit­ment strat­e­gy. It’s our crit­i­cal suc­cess fac­tor in build­ing trust and meet­ing rapid en­roll­ment goals in healthy vol­un­teer and chron­ic dis­ease stud­ies”.

Pa­tient ser­vices that sup­port re­cruit­ment and re­ten­tion

In­creas­ing­ly there is a di­verse of­fer­ing of unique ser­vices that en­gage with pa­tients from screen­ing through to study home vis­its. These ser­vices are al­so pow­er­ful pa­tient re­ten­tion part­ners.

Affin­i­ty Clin­i­cal Re­search

Krys His­cock, Man­ag­ing Di­rec­tor, Affin­i­ty Clin­i­cal Re­search

Affin­i­ty Clin­i­cal Re­search

Affin­i­ty Clin­i­cal Re­search is a pa­tient-cen­tric re­search or­gan­i­sa­tion that spe­cialis­es in pro­vid­ing sup­port to re­search vol­un­teers and in­ves­ti­ga­tors. Their team of home vis­it nurs­es lever­age tech­nol­o­gy to move re­search in­to the com­mu­ni­ty and in­to par­tic­i­pant’s homes. The dig­i­tal na­ture of the Affin­i­ty Clin­i­cal Re­search prac­tice means that they are not lim­it­ed by ge­og­ra­phy, with their lo­cal nurs­es pro­vid­ing es­sen­tial sup­port to en­sure safe­ty and re­ten­tion of sub­jects. Krys His­cock, Man­ag­ing Di­rec­tor, ad­vised that Affin­i­ty Clin­i­cal Re­search “con­ducts clin­i­cal tri­als across a wide range of ther­a­peu­tic ar­eas through part­ner­ships with mul­ti­ple med­ical spe­cial­ists and doc­tors. This ap­proach, along with an in-depth un­der­stand­ing of how pa­tients nav­i­gate the health­care sys­tem, in­creas­es the breadth and depth of our po­ten­tial par­tic­i­pant pool.”

Illing­worth Re­search Group

Illing­worth Re­search Group (Aus­tralia) Pty Ltd

Kevin Wight­man, Se­nior Di­rec­tor, Busi­ness and Cor­po­rate De­vel­op­ment, Illing­worth Re­search Group

Illing­worth is the in­dus­try leader in pro­vi­sion of pa­tient cen­tric and site friend­ly GCP Re­search Nurs­ing (RN) so­lu­tions. Illing­worth’s mo­bile RNs pro­vide pa­tients and their car­ers with a flex­i­ble and prac­ti­cal way to par­tic­i­pate in clin­i­cal tri­al vis­its from the fa­mil­iar­i­ty and safe­ty of their own home/work­place or school/col­lege. All of their nurs­es are GCP trained and clin­i­cal tri­al ex­pe­ri­enced and are ex­perts in pro­vid­ing per­son­al­ized in-home tri­al vis­its and study pro­ce­dures/as­sess­ments for pa­tients who live re­mote­ly, are un­able to trav­el, are im­muno­com­pro­mised or just lead­ing busy lives. “This per­son­al­ized and pa­tient cen­tric ap­proach has been shown to in­crease study par­tic­i­pa­tion in terms of both ini­tial re­cruit­ment and on­go­ing com­ple­tion of clin­i­cal tri­al vis­its and can there­fore dra­mat­i­cal­ly im­pact da­ta in­tegri­ty, qual­i­ty and tri­al com­ple­tion time­lines,” stat­ed Kevin Wight­man, Se­nior Di­rec­tor, Busi­ness and Cor­po­rate De­vel­op­ment.

A com­bi­na­tion of world class clin­i­cal tri­al in­tel­li­gence data­bas­es, in­no­v­a­tive re­cruit­ment tech­nolo­gies and a ded­i­cat­ed pri­vate site net­work po­si­tions Avance Clin­i­cal as the CRO of choice for sup­port­ing biotech’s with their ear­ly phase clin­i­cal tri­als.

Spot­light on Avance Clin­i­cal’s CRO Ca­pa­bil­i­ties

Full-ser­vice CRO with a 20-year track record

eClin­i­cal

At Avance Clin­i­cal you have the op­tion to de­ploy the lat­est eClin­i­cal so­lu­tions to max­imise the val­ue of your study da­ta and de­liv­er re­al-time vis­i­bil­i­ty on study progress. Our team works with eClin­i­cal lead­ers such as Medrio to of­fer reg­u­la­to­ry com­pli­ant and pa­tient cen­tric tools for rapid start-up and con­tin­u­al da­ta flow. Im­prove pa­tient en­gage­ment and da­ta col­lec­tion and stay in­formed at every step with Spon­sor vis­i­ble por­tals.

Some of the ben­e­fits of these ad­vanced tools in­clude:

• eS­ource
• eCon­sent
• ePro

Tech­nol­o­gy Part­ners:

Avance Clin­i­cal part­ners with best in class tech­nol­o­gy com­pa­nies right across our ser­vice de­liv­ery to en­sure a high qual­i­ty, seam­less­ly in­te­grat­ed elec­tron­ic so­lu­tion for our clients. Our tech­nol­o­gy part­ners in­clude the fol­low­ing:

• Medrio (eClin­i­cal So­li­tions)
• Me­di­da­ta (eClin­i­cal So­li­tions)
• Tri­a­log­ics (IWRS & ePro)
• Mas­ter­Con­trol (eLearn­ing Man­age­ment Sys­tem and eQual­i­ty Man­age­ment Sys­tem)
• Flex Data­bas­es (CTMS)
• Cetara – Phoenix Win­Non­lin (non-com­part­men­tal analy­sis (NCA), phar­ma­co­ki­net­ic/phar­ma­co­dy­nam­ic (PK/PD)

In Oc­to­ber, Avance Clin­i­cal ac­cept­ed the Mas­ter­Con­trol 2020 In­no­va­tion Ex­cel­lence Award recog­nis­ing our com­mit­ment to the use of world class tech­nolo­gies and in­no­va­tion.

“Avance Clin­i­cal in­vests sig­nif­i­cant­ly in the in­dus­try’s lead­ing clin­i­cal tech­nolo­gies mak­ing it one of the most ad­vanced CROs glob­al­ly for dig­i­tal clin­i­cal re­search man­age­ment and eClin­i­cal so­lu­tions,” said Avance Clin­i­cal’s CEO, Yvonne Lunger­shausen.

Clini­cReady

Gabriel Krem­mid­i­o­tis
PhD, BSC Hon
Chief Sci­en­tif­ic Of­fi­cer

Avance Clin­i­cal’s Clini­cReady team of sci­en­tif­ic and med­ical af­fairs spe­cial­ists com­prise PhD qual­i­fied in­di­vid­u­als with decades of ex­pe­ri­ence in in­dus­try and aca­d­e­m­ic re­search. They pro­vide clients with sci­en­tif­ic, reg­u­la­to­ry and med­ical writ­ing ser­vices, prepa­ra­tion of in­ves­ti­ga­tor brochures, clin­i­cal tri­al de­signs, study pro­to­cols, and pa­tient in­for­ma­tion and con­sent forms as well as clin­i­cal tri­al da­ta and clin­i­cal study re­ports.

“With our two decades of CRO ex­pe­ri­ence we have be­come acute­ly aware of the im­por­tance of ad­vis­ing clients ear­li­er in the de­vel­op­ment process, pri­or to them com­menc­ing pre­clin­i­cal safe­ty and tox­i­col­o­gy ac­tiv­i­ties, so they con­duct an ap­pro­pri­ate­ly bal­anced set of pre­clin­i­cal stud­ies to get the right da­ta re­quired for ap­proval of their first-in-hu­man study in Aus­tralia,” said Dr Gabriel Krem­mid­i­o­tis, Avance Clin­i­cal’s Chief Sci­en­tif­ic Of­fi­cer.

“Many of our clients are biotechs look­ing to get in­vestor sup­port to progress their project to demon­stra­tion of ear­ly Proof of Con­cept (POC) which will en­able them to ac­cess re­turn on their in­vest­ment through a li­cens­ing deal to Phar­ma,” said Dr Gabriel Krem­mid­i­o­tis.

With Clini­cReady, Avance Clin­i­cal’s team can act as a sur­ro­gate drug de­vel­op­ment de­part­ment for start-up com­pa­nies.

The Aus­tralian Ad­van­tage

Site Ini­ti­a­tion Vis­it (SIV) and Study Start can be achieved in 5 – 6 Weeks.

There are two al­ter­na­tive schemes to gain­ing ap­proval to con­duct a clin­i­cal tri­al in Aus­tralia.

In Aus­tralia, the ma­jor­i­ty (>90%) of clin­i­cal tri­als can be sub­mit­ted via the CTN scheme where­by pre­clin­i­cal da­ta sum­marised in an In­ves­ti­ga­tor Brochure are re­viewed by an HREC who then no­ti­fies the TGA of the out­come. This pro­vides an op­por­tu­ni­ty to con­duct ear­ly phase tri­als in Aus­tralia whilst prepar­ing doc­u­men­ta­tion re­quired for an IND sub­mis­sion to the FDA. Learn more here.

Watch our Clini­cReady In­for­ma­tion­al Video here.