Study Service

We offer com­plete ser­vice-pack­ages for stud­ies with in-vit­ro diag­nos­tic devices.

Our ser­vices cov­er all project phas­es from start to fin­ish, comprising:

  • Study design and planning
  • Eth­i­cal and reg­u­la­to­ry clearance
  • Sam­ple sourcing
  • Sam­ple analysis
  • Data man­age­ment and analysis
  • Report­ing

Back­bone of our study ser­vices is the unmatched qual­i­ty of our clin­i­cal sam­ples. Our Tar­get­ed Pro­cure­ment of human bio­ma­te­ri­als allows us to con­duct tai­lor-made stud­ies for your product.

Eth­i­cal and reg­u­la­to­ry clear­ance are a pre­req­ui­site for most stud­ies. Appli­ca­tions to insti­tu­tion­al review boards (eth­i­cal clear­ance) or pub­lic author­i­ties (reg­u­la­to­ry clear­ance) in dif­fer­ent coun­tries are our dai­ly busi­ness.
Fol­low­ing all require­ments from IVDR annex XIV, our stud­ies are audit-proof from the start.

Clinical Performance Studies

Clinical Performance Studies 

A clin­i­cal per­for­mance study tests the abil­i­ty of an IVD prod­uct to deliv­er results that cor­re­late with a spe­cif­ic clin­i­cal con­di­tion. Clin­i­cal Per­for­mance Stud­ies are the final and most cru­cial step before the CE con­for­mi­ty assessment.

We take care of the plan­ning, exe­cu­tion and report­ing of these stud­ies for you. In doing so, we strict­ly com­ply with IVDR and ISO 20916.

Layman Studies

If a man­u­fac­tur­er claims that their IVD prod­uct is intend­ed to be used by layper­sons, they must pro­vide evi­dence that the prod­uct is fit for this pur­pose. This evi­dence is gen­er­at­ed in lay­man or layper­son stud­ies. These stud­ies have spe­cial design require­ments and often include the col­lec­tion of usabil­i­ty data, e.g. test­ing the com­pre­hen­si­bil­i­ty of the IFUs (instruc­tions for use) for laypersons.

Our com­pa­ny-owned study cen­tre is the per­fect loca­tion for IVD lay­man studies!

Layman Studies
Preliminary Studies

Preliminary Studies

Pre-stud­ies are sup­posed to chal­lenge an IVD pro­to­type with native clin­i­cal sam­ples to see whether the devel­op­ment process is going in the right direc­tion.
While sam­ple qual­i­ty is crit­i­cal in order to detect prod­uct flaws ear­ly, time and price of pre-stud­ies should be as low as possible.

We have estab­lished tight­ly con­trolled pro­cure­ment path­ways for left­over sam­ples from a mul­ti­tude of med­ical indi­ca­tions which allow us to offer com­plete pre-study ser­vices designed for speed and cost reduction.

Studies according to Common Specifications 

For cer­tain IVDs, pub­li­cal­ly avail­able guide­lines exist – often referred to as Com­mon Spec­i­fi­ca­tions – con­tain­ing min­i­mal require­ments for sam­ple size and spec­i­fi­ca­tions for a val­i­da­tion study with the respec­tive device. Most com­mon exam­ples for such guide­lines are Comis­sion Imple­ment­ing Reg­u­la­tion (EU) 2022/1107 or the Tech­ni­cal Spec­i­fi­ca­tion Series of the WHO. Meet­ing these offi­cial require­ments is broad­ly accept­ed as suf­fi­cient or even manda­to­ry for con­for­mi­ty assess­ments. The require­ments are usu­al­ly chal­leng­ing but they do facil­i­tate study design greatly.

We have estab­lished sam­ple sourc­ing process­es specif­i­cal­ly for effi­cient­ly meet­ing Com­mon Spec­i­fi­ca­tion demands for mul­ti­ple device types already and will add more in the near future. This allows us to quote very com­pet­i­tive prices and time­lines for these stud­ies despite the high sam­ple num­bers that are required by the guidelines.

Tailor-made study design 

For the vast major­i­ty of IVDs, no Com­mon Spec­i­fi­ca­tions or oth­er offi­cial guide­lines exist. Study design for such prod­ucts relies exclu­sive­ly on their intend­ed pur­pose and the cur­rent state-of-the-art in med­ical prac­tice. Find­ing the cor­rect study design and sam­ple size with­out any guid­ance can be a chal­lenge. We can help you with this!
Our experts will design an IVDR-proof study for your device, includ­ing choice of prospec­tive or ret­ro­spec­tive design, sam­ple size cal­cu­la­tions, def­i­n­i­tion of in- and exclu­sion cri­te­ria, study site spec­i­fi­ca­tions, and assess­ment of eth­i­cal and reg­u­la­to­ry clear­ance requirements.