Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Di­nesh Sam­path Ran­garaj, Vice Pres­i­dent Health­care, Frost & Sul­li­van said:

“Novotech is in­ter­na­tion­al­ly rec­og­nized as a lead­ing re­gion­al full-ser­vice CRO in Asia- Pa­cif­ic. The com­pa­ny has achieved colos­sal suc­cess in Phase I through IV clin­i­cal tri­als and es­tab­lished it­self as a spe­cial­ized biotech CRO in the re­gion. In ad­di­tion, with its in­ter­na­tion­al ac­cred­i­ta­tion cou­pled with lo­cal knowl­edge, part­ner­ships, and ex­per­tise, Novotech has re­in­forced its pres­ence in Asia-Pa­cif­ic.”

Key to Novotech’s suc­cess ac­cord­ing to CEO Dr John Moller is the ex­pe­ri­ence of the Novotech peo­ple on the ground in 11 coun­tries.

“It all comes down to lo­cal knowl­edge.”

“We know Spon­sors are drawn to the re­gion be­cause of the ob­vi­ous ben­e­fits – cost, da­ta qual­i­ty, med­ical ex­cel­lence and re­search teams, start-up times and ac­cess to 1.4 bil­lion peo­ple in ur­ban ar­eas. But our cus­tomer feed­back shows they want a CRO that un­der­stands coun­try cul­tures and has the re­la­tion­ships with the med­ical in­sti­tu­tions and lead­ing in­ves­ti­ga­tors.”

“Lan­guage and cul­tures can be a re­al bar­ri­er un­less you have lo­cal teams that stream­line and man­age the process and take re­al ad­van­tage of what the re­gion can of­fer to the biotech sec­tor,” he said.

Novotech has al­so been on a mis­sion to lock-in pow­er­ful part­ner­ships with lead­ing med­ical and re­search in­sti­tu­tions across Asia to ac­cel­er­ate qual­i­ty clin­i­cal re­search for its clients. It has now signed 20 strate­gic part­ner­ships with hos­pi­tals and re­search in­sti­tu­tions giv­ing ac­cess to some of the best spe­cial­ty teams and vast pa­tient pop­u­la­tions.

See if the Asia-Pa­cif­ic is right for your next study. Click here to view the check­list.

Novotech’s Asia-Pa­cif­ic clin­i­cal re­search of­fers:

  • Large pa­tient pop­u­la­tion
  • Few com­pet­ing tri­als
  • Ef­fi­cient reg­u­la­to­ry sys­tem
  • High­ly qual­i­fied and ed­u­cat­ed med­ical pro­fes­sion­als
  • Low op­er­a­tional costs
  • Well sup­port­ed IT in­fra­struc­ture
  • High lev­el of GCP com­pli­ance
  • Ef­fi­cient tri­al man­age­ment and lo­gis­tics in­fra­struc­ture

Novotech us­es the best-in-class tech­nol­o­gy so­lu­tions:

  • CTMS (Or­a­cle­Siebel)
  • EDC (Me­di­dataR­ave, Or­a­cle In­form)
  • ETMF (Sure­clin­i­cal)
  • SAFE­TY (Or­a­cleAr­gus)

Novotech pro­vides clin­i­cal de­vel­op­ment ser­vices across all clin­i­cal tri­al phas­es and ther­a­peu­tic ar­eas:

  • Fea­si­bil­i­ty: De­tailed fea­si­bil­i­ty to iden­ti­fy the op­ti­mal coun­tries, sites and in­ves­ti­ga­tors for
    the study
  • Clin­i­cal Ser­vices: Pro­ject man­age­ment, pa­tient re­cruit­ment, mon­i­tor­ing and SDV
  • Cen­tral Lab: Pro­to­col man­age­ment, lab­o­ra­to­ry ser­vices, spec­i­men man­age­ment and pa­tient blood col­lec­tion ser­vices
  • Bio­met­rics: Ad­vance adap­tive clin­i­cal tri­al de­sign with Da­ta Man­age­ment, Clin­i­cal Pro­gram­ming, Bio­sta­tis­tics, PK/PD Analy­sis and Mod­el­ling
  • Reg­u­la­to­ry: Ethics and reg­u­la­to­ry sub­mis­sions, drug im­por­ta­tion and gov­er­nance
  • In­de­pen­dent QA Ser­vices: Ac­cred­it­ed to ISO 9001
  • Med­ical Ser­vices and Safe­ty: In­cludes med­ical, pro­to­col and clin­i­cal study re­port writ­ing im­por­ta­tion and gov­er­nance

IN­SIDE NOVOTECH
Q&A with Novotech Ex­ec­u­tives Rad­ha Jha – Di­rec­tor of Med­ical and Reg­u­la­to­ry and An­dries Claassen – Di­rec­tor of Bio­met­rics

Rad­ha Jha – Di­rec­tor of Med­ical and Reg­u­la­to­ry, Novotech

Q. What per­cep­tion do US biotechs have of the Asia Pa­cif­ic and how can a CRO sup­port them in their de­vel­op­ment in the re­gion?
R. (Rad­ha) With biotech com­pa­nies in­vest­ing in more com­plex and glob­al pro­grams and look­ing for ef­fi­cient tri­al start-up and com­ple­tion time­lines, we see biotech spon­sors in­creas­ing­ly con­sid­er­ing lo­ca­tions out­side of the US for their tri­als. Asia re­mains one of the fastest grow­ing re­gions for biotech-spon­sored tri­als and there is a grow­ing in­ter­est from US biotechs to ex­pand their clin­i­cal de­vel­op­ment here. While there are many ben­e­fits in run­ning clin­i­cal tri­als in Asia, spon­sors can of­ten face frag­ment­ed mar­kets and het­ero­ge­neous reg­u­la­to­ry path­ways. This in­creas­es the need to part­ner with a re­gion­al CRO spe­cial­ist who un­der­stands the reg­u­la­to­ry nu­ances of each coun­try.

Q. How is Novotech adapt­ing to the chang­ing needs in the biotech sec­tor?
R. (Rad­ha) There is sig­nif­i­cant growth in Novotech’s Med­ical team with the ad­di­tion of a spe­cial­ist Clin­i­cal De­vel­op­ment and Reg­u­la­to­ry con­sult­ing arm that is es­pe­cial­ly at­trac­tive to Asian clients. The team has now 30 staff with ca­pa­bil­i­ty to of­fer a full range of pre-clin­i­cal, reg­u­la­to­ry, med­ical and phar­ma­covig­i­lance con­sult­ing ser­vices in prepar­ing prod­ucts to en­ter clin­i­cal tri­als, pro­vide med­ical and safe­ty in­put dur­ing tri­al con­duct, and fi­nal­ly sup­port in reg­is­tra­tion, mar­ket­ing and post-mar­ket­ing ap­proval. With care­ful plan­ning up­front to sup­port our client’s clin­i­cal de­vel­op­ment pro­gram, in­clud­ing the use of well-de­signed in­no­v­a­tive pro­to­cols, we work hand-in-hand with our clients to ef­fec­tive­ly as­sist them with their prod­uct strat­e­gy.

An­dries Claassen – Di­rec­tor of Bio­met­rics, Novotech

Q. How is the de­mand from Biotech com­pa­nies evolv­ing in bio­met­rics and how is Novotech adapt­ing to these changes?
R. (An­dries) Clin­i­cal tri­al de­signs are get­ting in­creas­ing­ly com­plex and the Asia-Pa­cif­ic is now es­tab­lished as a pre­ferred des­ti­na­tion for drug de­vel­op­ment. This means that biotech com­pa­nies are look­ing for more scal­able so­lu­tions es­pe­cial­ly with re­gards to da­ta qual­i­ty and bio­met­rics. Novotech al­so pri­or­i­tizes in­vest­ment in the lat­est tech­nol­o­gy. For ex­am­ple, we re­cent­ly part­nered with Me­di­da­ta to help re­duce the over­all tri­al time­line and to pro­vide our clients with bet­ter da­ta vis­i­bil­i­ty for im­proved de­ci­sion-mak­ing. Novotech’s over­all EDC so­lu­tions for cap­tur­ing, man­ag­ing and re­port­ing pa­tient da­ta as well as cen­tralised med­ical cod­ing are world class and suit­ed for all our client needs.

Q. Novotech has made con­sid­er­able ef­fort to struc­ture its Bio­met­rics ac­tiv­i­ty, how will this af­fect your clients?
R. (An­dries) The Bio­met­rics team has grown to about 85 staff through­out Asia-Pa­cif­ic and we make a point at re­tain­ing and grow­ing our best tal­ents. This means we now have the fire­pow­er to han­dle the full Bio­met­ric ac­tiv­i­ties of glob­al tri­als and not on­ly of re­gion­al stud­ies. This makes a huge dif­fer­ence for our clients look­ing at tap­ping in­to the ben­e­fits of each re­gion for their glob­al tri­als.


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