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Business Development
enquiries@charite-research.org
Tel: +49 (0)30 450 539 200 -
Proof of Concept
Whether you plan a relatively small scale patient study or a somewhat larger one we are there for you. Our proven ability to recruit substantial numbers of patients across a wide range of therapeutic areas means that we can take you to the threshold of POC and then to its conclusion.
Studies with 100 patients can, in some indications, be envisaged as single-center studies. For larger studies, or those in populations with lower prevalence, CRO is there to take a leading role in terms of performance. Our capabilities in this area have already made us a core provider or site for many sponsors.
We have also shown that the need to adopt a multi-center approach to POC studies does not necessarily imply that biomarker and diagnostic implementation needs be limited by the lowest common denominator available to all participating sites. We have worked with key sponsors to develop and implement multi-center POC studies in which CRO’s unique ability to recruit larger numbers of patients and access the most advanced technologies is utilized to maximum effect. For instance, such an approach may see the basic study run at all contributing sites, with CRO also implementing the basic study design and supplementing it with additional diagnostics in a select subset of patients. As an example, the use of MRI in an RA POC study as a basic imaging technique, supplemented by ultrasound (a potentially more sensitive measure of sinuvitus) in patients enrolled at CRO. Such an approach is made valid by CROs ability to guarantee enrolment of a sufficient number of patients to the subgroup.
In other multi-center POC studies, CRO and its partners at Charité – Universitätsmedizin are providing central and core laboratory capabilities in addition to clinical participation. For example, CRO and our partners in Medical Immunology and Radiology are providing central immunology laboratory capabilities and central MRI evaluation.
Summary
Patients
Allergy & Respiratory
- Mild, Moderate and Persistent Asthma
- Mild, Moderate and Severe COPD
- Allergic Asthma
- Allergic Rhinitis
- Dermatitis
- Contact Allergies
Cardiovascular & Metabolic
- Type I Diabetes
- Type II Diabetes
- Hyperlipidemia
- Hypertension
- Heart Failure
- Obesity
- Peripheral Arterial Disease
Infectious Diseases
- Hepatitis C
- HIV
Inflammation & Immunology
- Inflammatory Bowel Disease
- Innate Immunity
- Multiple Sclerosis
- Psoriasis
- Psoriatic Arthritis
- Rheumatoid Arthritis
- Systemic Lupus Erythematosus
Neurosciences
- Addition
- Alzheimer’s
- Anxiety
- Chronic Depression
- Epilepsy
- Migraine
- Multiple Sclerosis
- Parkinson’s
- Schizophrenia
Ophthalmology
- Dry Eye Disease
- Glaucoma
- Macular Degeneration
Pain
- Chronic Pain
- Headache
- Neuropathic Pain
- Rheumatic Pain
Single-Center
In some cases it is possible to conduct POC studies as single center studies. The viability of undertaking a POC study in this way will be determined by the population in question and the sample size. In turn, the sample size will be determined by the endpoints and variability of them. Where the sample size and population make a single center approach viable, then efficiencies can be gained in terms of cost and timelines. Additionally, standardization is enhanced and variability reduced.
Multi-Center
Where a multi center approach is required or desired, Charité Research Organisation is committed to performing at the highest level and enhancing the sponsors overall experience. This not only includes making every effort to ensure CRO is the largest contributor to the study overall, but also an ability to extend our Project Management approach to manage small numbers of centers.
Core & Central Laboratory Capabilities
Charité Research Organisation in partnership with Charité has extensive biomarker and imaging experience and capabilities at its disposal. These resources can be used to provide central laboratory and core laboratory services for multi center studies. For instance, CRO is working extensively with the Medical Immunology Institute of Charité to develop and implement bespoke assays which can be used in both single and multi center settings. In each case the expertise in the assay development and processing is retained by the Medical Immunology Department, with logistics supported by CRO.
