Unrivalled ability to identify, screen and randomise patients

Everyone knows the conventional wisdom. A clinical site typically contributes 0-5 patients to a study. Upwards of 25% of sites deliver no patients at all. We don’t think that’s very good. In fact, in early development, we don’t think it’s an acceptable way forward in most cases. The implication is that practically every patient study requires a massively multi-centre approach. That’s just not a great solution in early development where evaluation of complex diagnostic and laboratory biomarker parameters are critical to decision making.

Our approach, which combines access to a large and varied database with ‘direct to patient’ marketing, is able to do better – much better. Our ability to enrol is based on the % prevalence of the indication and the estimated percentage of those patients meeting defined inclusion/exclusion criteria. For indications such as SLE, Sjögren’s or MS we may be able to target up to n=30-50 patients (randomised at our unit). For indications such as diabetes, RA, Asthma we can aim at up to n=100 patients (randomised at our unit) or even beyond. 

Study Population
Sjögren's Disease
Area

Autoimmune diseases

Approach

n=27 patients in a single-centre setting 

Challenges
  • Complex biomarkers
  • Labial salivary gland biopsies
  • HR ultrasound parotid gland imaging 
Enrolment Rates

2-3 patients per month

Recruitment Strategy

Direct-to-patient marketing and existing database

Duration of Participation
  • 4 weeks SCR
  • 24 weeks treatment + FUP
  • Long-term FUP
Interviewed
101
Informed
80
Screened
55
Enrolled
27
Completion
27

Healthy Volunteer Recruitment

Efficient enrollment of large numbers of healthy volunteers by means of study-specific marketing and a substantial, ever-growing database.

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Case Studies

Selected case studies to illustrate optimal value delivered by CRO's scientific expertise, operational excellence and world-leading recruitment.

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