Unrivalled performance in recruiting HVs, patients and special populations

We genuinely believe that no one in the world is able to recruit, screen and randomise patients and special populations for early clinical studies at the same level as CRO. We have built our reputation on an ability to complete patient studies using a single-centre approach when no one thought that would be possible which has several benefits. These include an increase in data integrity and shorter study timelines.

Indeed, we are often able to initiate and complete studies using a single-centre in less time than a comparable multi-centre approach – not least because of the time saved through the much faster study start-up and simplified logistics. The same is true for healthy volunteer studies. This is particularly beneficial for large healthy volunteer studies, such as Phase I biosimilar studies with hundreds of subjects.

Empowering single-centre and ‘reduced’ centre approaches

Our ability to recruit patients and special populations in unrivalled numbers means that a single-centre approach often becomes viable. This has immense implications for the speed with which a study can be set-up and ultimately on its cost. Reducing the numbers of sites required significantly reduces the number of providers and services required – in turn reducing costs.

If the population in question means that even CRO cannot offer a single-centre solution, our ability to enrol at orders of magnitude above conventional sites ensures the number of sites needed can, at the very least, be significantly reduced. So sponsors can reap the benefits of our recruitment capabilities in multi-centre as well as single-centre studies - while they are certainly more pronounced in the latter.

Direct to patient approach

As a part of the Charité – Universitätsmedizin Berlin family, we naturally benefit from an ability to collaborate with our clinical partners for patient access. However, 95% of our recruitment performance is driven by our unique ‘Direct to Patient’ marketing approach that utilises different communication channels dependent on the study population in question.

We have consistently demonstrated unrivalled abilities to translate direct communication with patients into screened and randomised patients. There is no gimmick involved, just a deep understanding of the disease in question, aspirations of the patients and the credibility and standing of the Charité name.

Country wide recruitment – single study centre

The established model of clinical development in patients typically envisages multiple sites close to the patients in question. Even if each site only enrols a handful of patients, this is viewed as an acceptable and ‘necessary’ approach. CRO has started to turn this approach on its head. In some cases, it has been possible to utilise a ‘national single centre’ approach.

This approach is focused on bringing the patients to the study site – namely the Charité Research Organisation unit in Berlin. This ultimately leads to improved consistency, control and data quality. It also reduces costs as additional patient travel and accommodation costs are significantly less than the costs of initiating and managing multiple additional sites.

Helping you eliminate compromises in protocol design that result from massive multi-centre approaches

By conducting studies using a single-centre approach – or by simply significantly reducing the overall number of sites needed – it is possible to minimise or eliminate typical protocol design and implementation compromises. For instance, a single-centre solution allows biomarkers to be processed locally, significantly simplifying logistics and improving quality for whole blood assays. Single- or reduced-centre approaches also allow more advanced diagnostics and methodologies to be included.

Such diagnostics and methodologies may provide sensitive and valuable data but are only useful if sites with access to them can enrol enough patients to make their inclusion worthwhile. By working with sites that have in-patient capabilities, compromises regarding in-house monitoring of subjects can be eliminated. In some cases a single- or reduced-centre approach may even allow you to reduce the number of required subjects, as dropouts and data variability are minimised.