In an era of in­creas­ing­ly com­plex clin­i­cal tri­als, spon­sors face a re­lent­less storm of da­ta—each byte a po­ten­tial break­through or a missed op­por­tu­ni­ty. De­spite ad­vances in tri­al de­sign and AI, out­dat­ed meth­ods for col­lect­ing, col­lat­ing and clean­ing da­ta of­ten hin­der ag­ile de­ci­sion-mak­ing, turn­ing clin­i­cal da­ta in­to a stum­bling block rather than a su­per­pow­er.

We must shift our fo­cus away from how much da­ta we can col­lect to en­sure we col­lect da­ta that mat­ters. By do­ing so in an in­te­grat­ed man­ner, we are able to trans­late that da­ta in­to in­tel­li­gence for ear­li­er, smarter de­ci­sion mak­ing.

How can we cut through the over­whelm­ing da­ta noise to ac­cel­er­ate life-chang­ing med­i­cines?

Parex­el is di­rect­ly ad­dress­ing these crit­i­cal needs with our in­no­v­a­tive In­te­grat­ed Da­ta De­liv­ery (IDD) ap­proach. IDD re­designs the en­tire da­ta ar­chi­tec­ture and se­quence, ef­fec­tive­ly dis­man­tling si­los, ac­cel­er­at­ing time­lines and sig­nif­i­cant­ly re­duc­ing ad­min­is­tra­tive bur­dens on sites. Our core phi­los­o­phy is to de­liv­er clean­er pa­tient da­ta faster, fos­ter­ing im­me­di­ate con­fi­dence in your de­ci­sion-mak­ing process­es.

IDD is built on a 'Touch Da­ta On­ce' prin­ci­ple, lever­ag­ing ad­vanced tech­nol­o­gy and re­de­fined roles for pur­pose-dri­ven op­er­a­tions in­stead of func­tion-dri­ven. This fun­da­men­tal op­er­a­tional shift cen­tral­izes da­ta cap­ture and re­view with­in a uni­fied tech­nol­o­gy plat­form, dras­ti­cal­ly min­i­miz­ing re­dun­dant han­dling.

How IDD achieves this:

• Site Da­ta Li­ai­son:  New Clin­i­cal Da­ta Mon­i­tors (CDMs) serve as the key point of con­tact for sites re­gard­ing all da­ta-re­lat­ed mat­ters, in­clud­ing da­ta re­view, query man­age­ment, and co­or­di­nat­ing site vis­its.
• In­stream Da­ta Clean­ing & Mon­i­tor­ing: We im­ple­ment con­tin­u­ous, in­stream da­ta clean­ing and mon­i­tor­ing. Da­ta are re­viewed in near re­al-time fol­low­ing pa­tient vis­its, and queries are gen­er­at­ed con­tem­po­ra­ne­ous­ly. This elim­i­nates tra­di­tion­al back­logs, pro­vid­ing an up-to-the-minute view of da­ta qual­i­ty.

A sig­nif­i­cant ben­e­fit of IDD is the re­de­f­i­n­i­tion of roles, par­tic­u­lar­ly for CDMs and CRAs (Clin­i­cal Re­search As­so­ciates). In tra­di­tion­al mod­els, in­di­vid­u­als work­ing in func­tion­al si­los spend con­sid­er­able time on of­ten over­lap­ping or re­dun­dant da­ta re­view and query man­age­ment. IDD or­ders da­ta re­view and clean­ing ac­tiv­i­ties to fol­low the pa­tient da­ta jour­ney and en­sure the right peo­ple are touch­ing the right da­ta at the right time.

This strate­gic shift al­lows CRAs to ded­i­cate more valu­able time to strength­en­ing site re­la­tion­ships, as well as com­plex is­sues, pa­tient safe­ty over­sights and pro­to­col ad­her­ence. They can act as gen­uine part­ners, pro­vid­ing sup­port and ed­u­ca­tion, rather than sole­ly as da­ta val­ida­tors. This leads to a bet­ter over­all site ex­pe­ri­ence, fos­ter­ing greater loy­al­ty and en­gage­ment, and ul­ti­mate­ly im­prov­ing both da­ta qual­i­ty and over­all tri­al de­liv­ery.

The ef­fi­ca­cy of Parex­el's IDD ap­proach is pow­er­ful­ly demon­strat­ed in a re­cent phase II/III mi­graine study. Com­par­ing an IDD study against two com­para­tor stud­ies us­ing tra­di­tion­al meth­ods, the re­sults were strik­ing:

The IDD study re­port­ed a mere 0.3% miss­ing pages (EDC + eDa­ta), a dra­mat­ic con­trast to the com­para­tor stud­ies, which saw miss­ing da­ta fig­ures of 33.9% and 29.2%, re­spec­tive­ly. Sim­i­lar­ly, IDD sig­nif­i­cant­ly re­duced the back­log of da­ta pend­ing Da­ta Man­age­ment re­view, with on­ly 17.6% com­pared to 42.7% in one com­para­tor study. These num­bers high­light ID­D's su­pe­ri­or ef­fec­tive­ness in proac­tive da­ta clean­ing, re­al-time is­sue res­o­lu­tion and en­sur­ing high­er da­ta qual­i­ty ear­li­er in the tri­al life­cy­cle.

Our clients con­sis­tent­ly praise ID­D's trans­for­ma­tion­al im­pact. A Head of Da­ta Man­age­ment rep­re­sen­ta­tive at a lead­ing Biotech com­pa­ny shared: "This proac­tive da­ta man­age­ment aligns strong­ly with our com­pa­ny's ob­jec­tive to be best-in-class in sub­mis­sion time­lines. It has al­so sig­nif­i­cant­ly stream­lined our in­ter­nal da­ta re­view process, as da­ta are now con­sis­tent­ly up to date and cleaned up­front — re­duc­ing de­lays and im­prov­ing over­all qual­i­ty."

Oth­er feed­back high­lights key im­prove­ments:

• Eas­i­er In­te­gra­tion: "The in­te­gra­tion of the CDM team in­to the study has been smoother and eas­i­er than ini­tial­ly ex­pect­ed."
• Faster Re­sponse Times:"Be­fore the CDM in­volve­ment, it took three to four days to get an­swers from sites, but now re­spons­es are of­ten re­ceived with­in the same day..."
• Im­proved Com­mu­ni­ca­tion: “It’s been nice to have our on­site CRA while still hav­ing the CDM avail­able to an­swer ques­tions and of­fer sup­port with­out re­ceiv­ing any ‘OOO – trav­el­ing for mon­i­tor­ing vis­it emails’. This lev­el of com­mu­ni­ca­tion and fol­low-up makes worlds of dif­fer­ence on a tri­al. This new strat­e­gy has been a won­der­ful ex­pe­ri­ence for our site.”

Parex­el's In­te­grat­ed Da­ta De­liv­ery cuts through the noise, sig­nif­i­cant­ly re­duces ad­min­is­tra­tive bur­den and pro­vides spon­sors with the agili­ty to ac­cel­er­ate break­throughs to mar­ket. De­mand the Parex­el In­te­grat­ed Da­ta De­liv­ery strat­e­gy to trans­form your clin­i­cal tri­als to­day.

Sarep­ta said the ef­fects of its Duchenne mus­cu­lar dy­s­tro­phy gene ther­a­py were durable three years af­ter treat­ment, based on longer-term find­ings from pa­tients in its key clin­i­cal tri­al.

The da­ta come af­ter a tu­mul­tuous year for Sarep­ta and its gene ther­a­py Ele­v­idys, in which there were two pa­tient deaths due to the one-time treat­ment.

The study com­pared pa­tients who re­ceived Ele­v­idys three years ago as part of the ther­a­py’s piv­otal study EM­BARK to an ex­ter­nal con­trol group, though com­par­isons with ex­ter­nal con­trols typ­i­cal­ly come with lim­i­ta­tions and po­ten­tial caveats. Com­pared to the con­trol group, the Ele­v­idys-treat­ed pa­tients saw a 4.39-point im­prove­ment in scores on a mo­tor skills test for Duchenne called the NSAA, Sarep­ta re­port­ed Mon­day morn­ing. The biotech al­so re­port­ed im­prove­ments on two oth­er mea­sures of mo­bil­i­ty at three years.