Save Time and Up to 43.5% on Clin­i­cal Tri­al Spend Con­duct­ing Aus­tralian and US Tri­als

Avance Clin­i­cal is the lead­ing Aus­tralian and US CRO for biotechs pro­vid­ing world-class clin­i­cal re­search ser­vices with FDA and EMA-ac­cept­ed da­ta across all phas­es. With Avance Clin­i­cal, biotech com­pa­nies can lever­age Aus­tralia’s sup­port­ive clin­i­cal tri­als en­vi­ron­ment which in­cludes no IND re­quire­ment plus a 43.5% Gov­ern­ment in­cen­tive re­bate on clin­i­cal spend. The CRO has been de­liv­er­ing clin­i­cal drug de­vel­op­ment ser­vices for in­ter­na­tion­al biotechs for FDA and EMA reg­u­la­to­ry ap­proval for the past two decades. The com­pa­ny has been rec­og­nized for the past three con­sec­u­tive years with the pres­ti­gious Frost & Sul­li­van CRO Best Prac­tices Awards.

Biotechs are tap­ping lu­cra­tive Aus­tralian fi­nan­cial and time sav­ing ben­e­fits for tri­als con­duct­ed in Aus­tralia and the US. In this re­port, we ex­plore ways to re­tain these fi­nan­cial and time ad­van­tages for con­duct­ing clin­i­cal tri­als in Aus­tralia and in par­al­lel or sub­se­quent phas­es in the US.

The Aus­tralian Ad­van­tage

When it comes to con­duct­ing clin­i­cal tri­als, Aus­tralia of­fers far more than just sci­en­tif­ic ex­cel­lence and reg­u­la­to­ry ef­fi­cien­cy. Aus­tralia has qui­et­ly emerged as a fi­nan­cial haven for biotech com­pa­nies seek­ing to max­i­mize their funds and re­turn on in­vest­ment. With a com­bi­na­tion of at­trac­tive fi­nan­cial in­cen­tives, cost-ef­fec­tive op­er­a­tions, and fa­vor­able in­tel­lec­tu­al prop­er­ty pro­tec­tion, Aus­tralia presents a com­pelling propo­si­tion for biotechs.

Sav­ing up to 43.5% on Clin­i­cal Tri­al Costs

Cen­tral to Aus­tralia’s at­trac­tive clin­i­cal tri­al land­scape is the Re­search and De­vel­op­ment (R&D) Tax In­cen­tive pro­gram which of­fers gen­er­ous re­bates for clin­i­cal tri­als. By con­duct­ing tri­als in Aus­tralia, biotechs can tap in­to these ben­e­fits to re­duce their clin­i­cal re­search costs by up to 43.5%.

Yvonne Lunger­hausen, CEO, Avance Clin­i­cal

“Avance Clin­i­cal has a proven track-record of da­ta ac­cep­tance by the FDA, EMA, MHRA and all oth­er ma­jor reg­u­la­to­ry bod­ies. By con­duct­ing tri­als in Aus­tralia with Avance Clin­i­cal, biotechs can ac­cess these ben­e­fits to re­duce their clin­i­cal re­search costs by up to 43.5%.” Avance Clin­i­cal CEO Yvonne Lunger­shausen

Re­tain­ing the Re­bates for Lat­er Phas­es in the Unit­ed States

Part­ner­ing with Avance Clin­i­cal as their CRO for stud­ies in­volv­ing both Aus­tralian and the US sites al­lows biotechs the max­imise the fi­nan­cial in­cen­tives with the R&D pro­gram. The breadth of ser­vices Avance Clin­i­cal of­fers in Aus­tralia opens the op­por­tu­ni­ty for el­i­gi­ble biotechs to ac­cess the R&D re­bate, in­clud­ing the fol­low­ing:

• Med­ical Writ­ing
• Project Man­age­ment
• Clin­i­cal Mon­i­tor­ing
• Bio­met­rics (Da­ta Man­age­ment, Sta­tis­ti­cal Pro­gram­ming, CDISC, Bio­sta­tis­tics and Phar­ma­co­ki­net­ics)
• Safe­ty and Phar­ma­covig­i­lance

Avance Clin­i­cal has as­sist­ed hun­dreds of biotechs based in the US, UK, Eu­rope, and Asia with the sim­ple process re­quired to ac­cess these fi­nan­cial re­bates. This R&D pro­gram can free up fi­nan­cial re­sources that can be redi­rect­ed to­wards ad­vanc­ing the pipeline and com­mer­cial­iza­tion ef­forts in the US.

Sav­ing Up to 9 Months on a Clin­i­cal Pro­gram

Biotechs have seen sig­nif­i­cant ben­e­fits by con­duct­ing clin­i­cal tri­als with Avance Clin­i­cal in Aus­tralia and the US. This strat­e­gy saves time and costs by start­ing quick­ly in Aus­tralia and be­ing able to piv­ot quick­ly to the US to ex­tend their clin­i­cal pro­grams. Re­cent­ly, a US-based biotech client was able to ac­cel­er­ate their pro­gram by 9 months by us­ing this strat­e­gy. Biotechs can con­tin­ue their tri­als in the US while tak­ing ad­van­tage of the breadth of ser­vices in Aus­tralia and max­imise their R&D re­bate by claim­ing el­i­gi­ble ac­tiv­i­ties through their clin­i­cal de­vel­op­ment pro­grams.

Avance Clin­i­cal has ex­pe­ri­enced teams on the ground in Aus­tralia, New Zealand and the US and have heav­i­ly in­vest­ed in tech­nol­o­gy and sys­tems as well as in­dus­try ex­pe­ri­enced ex­perts to sup­port biotech glob­al ex­pan­sion of their clin­i­cal de­vel­op­ment pro­grams.

Gabriel Krem­mid­i­o­tis (Chief Sci­en­tif­ic Of­fi­cer), Yvonne Lunger­shausen (CEO) and Jor­gen Mould (Head of Sci­en­tif­ic & Reg­u­la­to­ry Af­fairs).

Ac­cess the Avance Clin­i­cal Glob­al­Ready Pro­gram

In­creas­ing­ly, biotechs are join­ing the Avance Clin­i­cal Glob­al­Ready pro­gram which takes them from Aus­tralia to the US as they progress their tri­als, while re­tain­ing the same CRO.

Con­tin­u­ing to work with Avance Clin­i­cal in the US for lat­er phase tri­als of­fers stream­lined process­es:

• Re­sult­ing in faster start-up
• Cen­tral­ized da­ta and re­port­ing
• Ac­cess to a di­verse pa­tient pool
• Ac­cess to renowned key opin­ion lead­ers
• Glob­al recog­ni­tion and ac­cep­tance
• A trust­ed team with deep ex­pe­ri­ence around a clin­i­cal pro­gram.

While biotechs can re­tain the Avance Clin­i­cal team as they launch their clin­i­cal pro­gram in the US, there are al­so op­por­tu­ni­ties to ben­e­fit from valu­able fi­nan­cial in­cen­tives from Aus­tralia.

Li­ah­na Toy,
Vice Pres­i­dent,
Com­mer­cial Busi­ness
De­vel­op­ment,
Avance Clin­i­cal

“While biotechs can re­tain the Avance Clin­i­cal team as they launch their clin­i­cal pro­gram in the US, there are al­so op­por­tu­ni­ties to ben­e­fit from valu­able fi­nan­cial in­cen­tives from Aus­tralia.” Avance Clin­i­cal Vice Pres­i­dent, Com­mer­cial Busi­ness De­vel­op­ment, Li­ah­na Toy

Hy­brid De­cen­tral­ized Clin­i­cal Tri­als Ben­e­fits

These ben­e­fits are fur­ther en­hanced with the use of hy­brid De­cen­tral­ized Clin­i­cal Tri­al (DCT) tech­nol­o­gy.

Glob­al­Da­ta re­cent­ly iden­ti­fied Avance Clin­i­cal as the lead­ing CRO glob­al­ly for the use of DCT tech­nolo­gies.

“As we em­brace the pow­er of de­cen­tral­ized ap­proach­es, we not on­ly en­hance pa­tient en­gage­ment and ac­ces­si­bil­i­ty but al­so pave the way for a more ef­fi­cient and eco­nom­i­cal fu­ture in clin­i­cal re­search.” Avance Clin­i­cal CEO Yvonne Lunger­shausen

The nu­mer­ous ben­e­fits of im­ple­ment­ing a de­cen­tralised ap­proach in­clude:

• Im­proved par­tic­i­pant re­cruit­ment
• En­hanced par­tic­i­pant en­gage­ment
• Pa­tient-cen­tric ap­proach
• Im­proved pa­tient di­ver­si­ty
• In­creased da­ta qual­i­ty and in­tegri­ty
• Faster tri­al time­lines re­sult­ing in cost sav­ings
• Re­al-world ev­i­dence gen­er­a­tion
• Bet­ter tri­al scal­a­bil­i­ty

Aus­tralia’s Cost-Ef­fec­tive Op­er­a­tions

While Aus­tralia main­tains high stan­dards of med­ical care and re­search, the coun­try boasts a cost-ef­fec­tive en­vi­ron­ment for con­duct­ing clin­i­cal tri­als. Op­er­a­tional costs, in­clud­ing site ini­ti­a­tion, pa­tient re­cruit­ment, and tri­al man­age­ment, are of­ten more fa­vor­able in Aus­tralia com­pared to oth­er coun­tries with sim­i­lar in­fra­struc­tures. This cost ad­van­tage is es­pe­cial­ly sig­nif­i­cant for large-scale tri­als that re­quire sub­stan­tial re­sources and pa­tient en­rol­ment. By con­duct­ing tri­als in Aus­tralia, biotechs can max­i­mize their bud­get and achieve cost ef­fi­cien­cies with­out com­pro­mis­ing on qual­i­ty or pa­tient safe­ty.

Aus­tralia’s In­tel­lec­tu­al Prop­er­ty and Da­ta Pro­tec­tion

One of the para­mount con­cerns for biotechs when con­duct­ing clin­i­cal tri­als is the pro­tec­tion of in­tel­lec­tu­al prop­er­ty (IP) and tri­al da­ta. Aus­tralia is wide­ly rec­og­nized for its ro­bust IP laws and rig­or­ous pro­tec­tion mea­sures, pro­vid­ing spon­sors with peace of mind. The coun­try up­holds strin­gent con­fi­den­tial­i­ty and da­ta se­cu­ri­ty stan­dards, en­sur­ing that spon­sors’ pro­pri­etary in­for­ma­tion re­mains safe­guard­ed through­out the tri­al process. This lev­el of IP pro­tec­tion fos­ters an en­vi­ron­ment con­ducive to col­lab­o­ra­tion, in­no­va­tion, and long-term suc­cess.

Aus­tralia’s fi­nan­cial ad­van­tages for con­duct­ing clin­i­cal tri­als are con­sid­ered the best in the world, mak­ing it an in­creas­ing­ly at­trac­tive des­ti­na­tion for biotechs seek­ing a lu­cra­tive re­turn on clin­i­cal in­vest­ment. With a range of fi­nan­cial in­cen­tives, cost-ef­fec­tive op­er­a­tions, and ro­bust in­tel­lec­tu­al prop­er­ty pro­tec­tion, Aus­tralia pro­vides a fer­tile ground for spon­sors to op­ti­mize their re­search bud­gets in Aus­tralia and the US.

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