Clinical Trials
Compared to synthetic drugs, natural products are often characterized by small effect sizes and by a delayed onset of the effects. The selection of the study population, the assessment parameters (incl. documentation), the course of study, and the analytical methods have to address these particularities.
To reflect different client needs, study purposes, regulatory frameworks and budgets, a&r has implemented a flexible quality system. Each study is assigned to one of three categories which define the level of quality management that is applied.
Besides a&r own study center, we work in close collaboration with the Charité (Europe’s largest university hospital) in Berlin as well as with other polyclinics. Thus, we can offer a broad spectrum of analytical methods such as state of the art diagnostics along with bedded unit capacities (including sleep lab).
Defining the scope of a clinical trial
- Understand your needs (e.g. support product commercialization, meet marketing claims, achieve regulatory objectives)
- Identify key issues
- Identify all experts required
- Conduct feasibility research
Designing the clinical trial
- Evaluate and identify the right study population (e.g. subjects at risk)
- Select parameters/biomarkers
- Conduct literature research
- Develop the study design:
- In line with guidelines and regulatory requirements in a cross-functional approach by liaising with regulatory experts in-house
- Adapted to the stage of the product life cycle
Trial set-up and conduct
- Find the optimal set-up to maximize the success rate
- Appropriate EC/regulatory submission
- Refined site selection
- Most successful recruitment due to our own study site including a subject database and network of investigators committed to natural health products
- Specific support measures to improve compliance (e.g. alerts, ePRO)
- Continuous project risk management to ensure high-quality data and project delivery in time & budget
Clinical trial reporting
- Clinical study report
- Maximizing the impact
- KOL network for expert review
- Publications of relevant outcomes in prestigious journals
Get in touch with us
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