Clinical & Preclinical Substantiation Strategy
From Biological Plausibility to Measurable Health Outcomes
Many nutrition studies fail because there is a disconnect between mechanism, study design, and measurable outcomes. We help clients translate biological plausibility into clear substantiation pathways, defining which outcomes can realistically be demonstrated in humans and how.
Our work includes mapping existing evidence, identifying gaps, and defining whether preclinical, safety, tolerance, or human intervention studies are required. We design substantiation strategies across a wide range of health areas, including gut health, early life nutrition, weight management, metabolic health, immunity, and digestive comfort.
This structured approach ensures that studies are not only scientifically sound, but also relevant to the intended product, population, and regulatory context. By defining endpoints, biomarkers, and populations upfront, we help clients avoid inconclusive trials that cannot be translated into claims or credible communication.
Designing and Managing Clinical and Safety Studies Across Contexts
Einerhand Science & Innovation has extensive hands-on experience in clinical study design, management, and interpretation. As an interim team member within a large infant formula company, Sandra Einerhand led and supported a global nutrition science team over a 1.5-year period, overseeing the design, execution, and interpretation of multiple clinical studies across different regions.
In addition, we have supported ingredient suppliers in designing safety and tolerance studies required for novel food approval, ensuring alignment with regulatory expectations while maintaining scientific rigor. Our role typically includes top-level study design, endpoint selection, protocol review, and interpretation of outcomes—working closely with internal teams and external partners.
We collaborate with a trusted network of clinicians, academic researchers, and CROs, enabling studies to be executed by experienced parties while we safeguard scientific coherence and strategic relevance.
Expert-Led Substantiation Roadmaps and Future-Oriented Study Design
Beyond individual studies, we help clients design integrated preclinical and clinical substantiation roadmaps that support long-term innovation and portfolio development. This includes defining the sequence of studies required to move from early evidence to claim-ready outcomes.
Our expertise is continuously informed by active involvement in scientific expert groups. For example, Sandra Einerhand is currently a member of ILSI task forces addressing questions such as which postbiotics are most relevant in early life and which biomarkers are appropriate to substantiate postbiotic benefits. This ensures that our advice reflects current scientific consensus and emerging regulatory expectations.
We have applied this approach for ingredient companies, food manufacturers, and start-ups, designing top-level clinical trial concepts that balance ambition with feasibility and risk management.
What Clients Gain
- Substantiation strategies aligned with scientific and regulatory expectations
- Reduced risk of failed or non-usable studies
- Clear guidance on endpoints, biomarkers, and study design
- Access to trusted clinical, academic, and CRO networks
Typical Deliverables
- Preclinical and clinical substantiation roadmaps
- Top-level human intervention study designs
- Safety and tolerance study strategies
- Endpoint and biomarker selection frameworks
- Scientific interpretation and strategic guidance
Frequently Asked Questions (FAQ)
A clinical substantiation strategy defines which studies are needed, in which order, and with which endpoints to support a specific health benefit or regulatory objective.
Yes. We regularly support ingredient companies in designing safety and tolerance studies aligned with novel food and regulatory requirements.
Yes. Early life nutrition is a core expertise area, including extensive experience with infant formula clinical studies, safety considerations, and age-appropriate biomarkers.
Absolutely. Biomarker and endpoint selection is a key part of our work, informed by current science, regulatory guidance, and expert group involvement (e.g. ILSI task forces).
As a nutrition science consultant helping startups as well as large multinationals, I can honestly say that all my clients find this extremely important for credibility among consumers and to convince authorities that the solutions actually work in the target population. It is not enough to just provide in vitro or animal data and claim that it also works in humans. There are many examples demonstrating that this type of preclinical work doesn’t translate to humans. I realize that this is a costly exercise, but human trials are mandatory to prove efficacy. Authorities (EFSA, FDA) require robust evidence; claims must be specific, substantiated, and targeted. Science-backed products command premium pricing and consumer loyalty.
Not always. In some cases, existing scientific literature may already provide sufficient evidence to support a product’s positioning. However, when companies aim to make stronger health benefit claims, differentiate their ingredient, or support regulatory submissions, human clinical studies are often necessary. A scientific assessment helps determine whether new research is required or whether existing evidence can be leveraged.
The optimal study design depends on the target population, health outcome, regulatory context, and product format. Common designs include:
- Randomized controlled trials (RCTs)
- Crossover studies
- Dose-response trials
- Observational or real-world studies
Endpoints must be clinically relevant, measurable, and aligned with the intended claim.
Preclinical research typically includes in vitro experiments, mechanistic studies, and animal models that explore biological mechanisms or proof of concept. Clinical substantiation involves human intervention studies designed to demonstrate measurable health outcomes in the target population. Preclinical work often helps clarify mechanisms of action and refine hypotheses, while clinical studies provide the highest level of evidence for health benefits.