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Diag­nos­tics Stud­ies accord­ing to IVDR 2017/746

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Ethical and regulatory clearance – Clinical validation takes longer than you think!

The new IVDR tran­si­tion­al peri­ods that have been pub­lished in Jan­u­ary 2022 took some pres­sure from all of us who still need … 
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Prospective clinical performance studies – Worth the effort?

In the IVDR-era, clin­i­cal per­for­mance stud­ies have gained much impor­tance. In fact, this expen­sive but nec­es­sary step in IVD-devel­op­ment is one of the most broadly … 
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Careful with the terms ‘prospective’ and ‘retrospective’ – Are you referring to study design or sample procurement?

In this arti­cle, we would just like to raise aware­ness for a ter­mi­nol­o­gy issue which is prone to cause … 
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Grafik ICS Clinical Services Okt 2023 Entwurf 1

Study designs are as indi­vid­ual as IVD devices and their intend­ed pur­pos­es. Every detail of study design – par­tic­u­lar­ly sam­ple size cal­cu­la­tion – can have a huge impact on fea­si­bil­i­ty as well as price and lead time. The very first step of any val­i­da­tion project is there­fore the pre­cise def­i­n­i­tion of the product’s intend­ed pur­pose and a cor­re­spond­ing study design.

IVDR and ISO 20916 express clear expec­ta­tions regard­ing con­tent and struc­ture of a per­for­mance study plan. We can gen­er­ate the study plan for you or you may approach us with a study plan your­self. Either way, we will take care that the sub­mit­ted study plan is com­pli­ant with all applic­a­ble guidelines.

Per­for­mance stud­ies with human spec­i­mens must be approved by ethics com­mit­tees or insti­tu­tion­al review boards (IRBs) and in some cas­es also a gov­ern­men­tal author­i­ty. This require­ment can be time-con­sum­ing, espe­cial­ly when for­mal errors result in addi­tion­al review ses­sions. Learn more.

Our sam­ples come from sources that cor­re­spond to your product’s intend­ed pur­pose; as demand­ed by the IVDR. The sam­ple col­lec­tions we organ­ise and mon­i­tor take place in hos­pi­tals, med­ical prac­tices, blood dona­tion cen­tres, or nurs­ery homes, specif­i­cal­ly fol­low­ing the indi­vid­ual require­ments of your prod­uct. Learn more.

Donor recruit­ment entails the gen­er­a­tion of patient infor­ma­tion and informed con­sent forms that must sat­is­fy the good prac­tice pro­vi­sions of the nation­al ethics boards. Being in direct con­tact with the study par­tic­i­pants calls for the respon­si­bil­i­ty that par­tic­i­pants are kept informed and that their safe­ty and dig­ni­ty is main­tained through­out the study process. This is par­tic­u­lar­ly the case in lon­gi­tu­di­nal stud­ies with mul­ti­ple dona­tions from the same donors.

Suit­able donors for a study can be rare, so max­i­mum care must be giv­en that sam­ples main­tain the high­est pos­si­ble qual­i­ty between col­lec­tion and analy­sis. Apply­ing the right pre-ana­lyt­i­cal con­di­tions at every step is key. Avoid­ing addi­tion­al obsta­cles such as pro­longed delay in cus­toms dur­ing inter­na­tion­al stud­ies requires an expe­ri­enced logis­tics team.

Sam­ple analy­sis gen­er­ates the data that the whole study revolves around. The sam­ples that have been col­lect­ed for this pur­pose are often used up the process. Hence, any mis­takes and impre­ci­sions must be kept to an absolute min­i­mum. The require­ments for guar­an­tee­ing this dif­fer great­ly between val­i­da­tions of point-of-care devices and lab devices.

Mon­i­tor­ing is not only required by IVDR and ISO 20916 but is also an essen­tial means of con­trol over data qual­i­ty, espe­cial­ly dur­ing inter­na­tion­al stud­ies. The most well writ­ten study plan or inves­ti­ga­tor brochure may be mis­in­ter­pret­ed by study nurs­es or inves­ti­ga­tors. Check­ing remote­ly or on-site whether all process­es are imple­ment­ed and exe­cut­ed as intend­ed, is vital for a suc­cess­ful study project.

The gen­er­a­tion of clin­i­cal data is the pri­ma­ry goal of any study, so dili­gent man­age­ment of it is anoth­er cor­ner stone in this process. The allo­ca­tion and repro­ducibil­i­ty of blind­ed sam­ple IDs to left­over sam­ples, source data, and reports must be guar­an­teed for decades of archiving.

Sta­tis­ti­cal analy­ses are required at the very begin­ning and the very end of a study. At the begin­ning, a thor­ough sta­tis­ti­cal assess­ment of a suit­able sam­ple size is already a deci­sive mile­stone that will be reviewed by IRBs, gov­ern­men­tal author­i­ties, and noti­fied bod­ies. At the end of the study, bio­sta­tis­tics will trans­late the raw data points into the per­for­mance para­me­ters that your prod­uct will be judged upon.

Our final deliv­er­able to you will be the study report togeth­er with the raw data. Our reports are gen­er­at­ed fol­low­ing guide­lines and stan­dards such as STARD 2015 and ISO 20916.

Learn more about our Study Services
ALL IN ONE

Plan­ning, sam­ple col­lec­tion, analy­sis, and report­ing. IVD stud­ies from start to finish.

QUALITY

Dili­gent qual­i­ty man­age­ment, cer­ti­fied accord­ing to ISO 9001:2015 and ISO 13485:2021.

VERSATILITY

Active in all med­ical fields thanks to our glob­al net­work of clin­i­cal partners.

EXPERIENCE

20 years in the diag­nos­tics indus­try. High­est famil­iar­i­ty with IVD and cer­ti­fi­ca­tion processes.

SECURITY

Imple­men­ta­tion of all applic­a­ble stan­dards and guide­lines for guar­an­teed compliance.

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in.vent Diagnostica GmbH

Neuendorfstraße 17
16761 Hennigsdorf

P: +49 (0) 3302 55199-550
F: +49 (0) 3302 55199-999

Mail: ics@inventdiagnostica.de