Erinaco SRLs

Bridging science and practice to help new therapies reach patients

Evidence Development Impact

We help biotech and pharmaceutical teams build strong evidence, navigate clinical development and deliver high-value medical strategy

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Our Expertise

Clinical Development

End-to-end support from early strategy to late-phase execution, including Target Product Profiles, Clinical Development Plans and risk assessments.

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Medical Affairs

Medical strategy, KOL engagement, data generation planning and scientific communication that strengthens your product value.

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Real-World Evidence

Design and delivery of RWE programmes, registries, burden-of-illness studies and evidence generation frameworks supporting regulatory and market needs.

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Clinical Development services

Target Product Profile (TPP)

The Target Product Profile (TPP) is the core R&D document that defines the intended future profile of your medicine. Developed by an integrated team where clinical development and medical affairs experts plays a central role, it serves as the foundation for evidence generation, product positioning and eventual commercial success.

A well-designed TPP outlines multiple development scenarios, aligned with probability-of-success assumptions, ensuring that strategic decisions are guided by robust, forward-looking science.

Clinical Development Plan (CDP)

The Clinical Development Plan (CDP) is the central document guiding the full clinical development pathway of a medicine. It outlines all required studies from Phase I to Phase IV that are essential for achieving market authorisation and for generating additional evidence to support market access and other strategic needs.

The CDP also incorporates region-specific data requirements (e.g., FDA, EMA), paediatric development obligations and country-level considerations. In addition, it provides a high-level overview of the registration strategy and planned interactions with regulatory agencies, ensuring a coherent and efficient development programme.

Clinical trials

Phase I – First-in-Human (FIH)
The first administration of a new molecule to humans, establishing initial safety, tolerability and pharmacokinetics.

Phase I – PK/PD/Bioequivalence and related studies
Conducted in either healthy volunteers or patients, these studies characterise the pharmacokinetic and pharmacodynamic profile, bioequivalence and other key properties of the drug.

Phase II – Safety
Performed in the target patient population to identify safety signals, refine dosing and inform subsequent study design.

Phase II – Proof-of-Concept (PoC) / Proof-of-Mechanism (PoM)
Trials designed to generate early efficacy data and demonstrate biological activity. These studies are critical for informing the Phase III GO/NO-GO decision.

Phase I/II Hybrid Studies
An increasingly common approach that combines FIH and PoC/PoM elements within a single programme, accelerating timelines and enabling earlier decision-making on therapeutic potential.

Phase III – Registration Studies
Pivotal trials required for marketing authorisation. While typically designed as two pivotal studies, regulatory interactions may allow tailoring of the design to optimise data collection. Futility analyses can be particularly valuable in high-risk programmes.

Phase III – Market Access Studies
Additional pre-authorisation evidence generation aimed at payer and HTA needs. These studies do not form part of the CTD submission but may include comparative studies (blinded or unblinded) to inform pricing, reimbursement and competitive positioning.

Phase IV – Post-Authorisation Studies
Post-marketing trials that address further scientific, safety or positioning questions, including exploration of responses in specific subpopulations within the approved indication.

Investigator-Initiated Trials (IITs)
Studies designed and led by investigators, with pharmaceutical company support (e.g., study drug supply, services or funding) to explore independent scientific hypotheses and generate complementary evidence.

Data review and interpretation

Data review is one of the most critical components of any clinical trial. It is a continuous process that begins on the very first day of data collection and continues well beyond study closure. The accumulated data support the pre-specified analyses and enable a wide range of post-hoc evaluations, including hypothesis generation for future studies.

Accurate and balanced data interpretation is equally essential. At this stage, the foundations of the future marketing authorisation package – including the Summary of Product Characteristics (SmPC) – are established. Objectivity is crucial, and multiple forms of scientific advice can be leveraged to ensure that interpretation remains robust, evidence-based and aligned with regulatory expectations.

Clinical development digital and AI tools

Today, a wide range of digital tools enables high-quality data collection and offers valuable insights into patients’ well-being beyond traditional site visits. Selecting the right tools is essential to ensure data integrity, patient usability and meaningful clinical outcomes.

The introduction of AI is opening even greater opportunities in clinical research. AI-driven technologies can support numerous processes – from improving routine data over-reading and detecting outliers linked to patient well-being, to predicting treatment response and identifying early safety or efficacy patterns. When implemented correctly, these tools significantly enhance the depth, quality and efficiency of evidence generation.

Interactions with regulators

Interaction with regulators is a complex, multi-step process that begins with the development of the Briefing Book (BB). This document summarises the project background, existing evidence, key scientific and regulatory questions and the company’s preliminary position on each point. Once the BB is finalised and submitted, a regulatory meeting is scheduled, giving the company the opportunity to present its rationale in greater detail and discuss issues of interes directly with the agencies.

Following the meeting, companies are typically required to prepare and submit a draft of the meeting minutes within the specified timeline, which the regulators then use to finalise their formal written response.

Regulatory agencies operate under well-defined timelines from the moment a meeting request is submitted, although official clock-stop periods may occur. In practice, companies begin preparing the BB long before the request is filed, and the full cycle — from the initial decision to engage with regulators to the receipt of the final written advice — may extend to a year or more. This is why early planning of regulatory interactions is essential and must be embedded in the Clinical Development Plan (CDP) and other strategic documents.

Clinical assessment of the operations

While the operations function is the technical engine of any clinical development programme, it is essential that planning is driven by sound scientific and medical rationale and practicalites. Occasionally, internal operational teams or external vendors may propose projects without adequate clinical assessment. Such initiatives can be inefficient, misaligned with patient and product needs or, in the worst cases, detrimental to the overall development strategy.

To avoid these risks, scientific and medical input must be incorporated from the outset or, at minimum, a rigorous expert review must be undertaken before the programme begins. Early scientific oversight ensures that all activities are purposeful, evidence-based and fully aligned with the strategic direction of the clinical development plan.

Data and safety monitoring boards (DSMB)

This is a highly formalised activity designed to provide independent oversight of patient safety and study conduct. A Data Safety Monitoring Board (DSMB) enables the sponsor to maintain real-time visibility of accumulating data and to obtain impartial expert judgement throughout the course of a clinical trial. DSMBs can be integrated into trial protocols to perform predefined safety reviews, assess emerging signals and make recommendations that protect both patients and the integrity of the study.

Advisory boards

This is a less formal type of expert engagement used to obtain scientific or strategic advice outside the context of a clinical trial. Such interactions can be highly effective at multiple stages of a project – from early hypothesis generation and interpretation of study results to shaping the Target Product Profile (TPP), assessing new indications or evaluating novel applications. Expert input at the right time strengthens decision-making, reduces uncertainty and ensures that development choices remain clinically and commercially meaningful.

Medical Affairs services

Launch readiness review (LRR)

One of the most critical steps for a successful launch, the Launch Readiness Review (LRR) provides a comprehensive overview of the medical affairs launch strategy and its supporting tactical actions. It offers a clear understanding of all interlinked elements – including timelines, resources and budget – ensuring that the organisation is fully prepared for an effective and coordinated launch.

Evidence generation plan (EGP)

The Evidence Generation Plan (EGP) is a strategic document that complements the Clinical Development Plan (CDP) from the medical affairs perspective. Its primary purpose is to define a clear roadmap for evidence generation across the company’s projects. An EGP may be product-specific or disease-focused, ensuring that all evidence needs are anticipated and aligned with scientific, clinical and commercial priorities.

Medical affairs strategy

A medical affairs strategy must be developed early and continuously updated as the product profile, disease understanding and scientific landscape evolve. It is essential to begin shaping this strategy and implementing key activities as soon as medical affairs becomes involved in the project.

A robust medical affairs strategy is a comprehensive, cross-functional plan that guides the organisation through the scientific, clinical and stakeholder activities required to ensure the success of the product.

OMNI-channel dissemination of data

Today, healthcare professionals (HCPs) and healthcare organisations (HCOs) receive information through thousands of different channels. Beyond traditional modes of scientific communication – such as congresses, publications and in-person visits – HCPs and HCOs increasingly rely on social media, digital platforms, specialised monitoring tools and a wide range of online sources.

It is therefore essential to ensure that information about your medicines or projects is disseminated accurately, appropriately and through the right channels, so that it reaches stakeholders in a credible and scientifically meaningful way.

Medical affairs AI tools

AI tools in medical affairs represent a rapidly evolving and highly dynamic field. When used appropriately, they can substantially enhance day-to-day activities – from generating insights and monitoring progress to analysing unmet needs and identifying emerging scientific trends.

It is essential to ensure that the selected technologies genuinely support the medical affairs strategy and strengthen routine operations, rather than adding unnecessary complexity.

Healthcare professionals (HCPs) / organisations (HCOs) interactions

Interaction with HCPs and HCOs is a crucial component of medical affairs activity. Using scientific data as the foundation, a meaningful scientific dialogue is established between the company and external healthcare stakeholders. This is a highly specific and sensitive type of engagement, as HCPs and HCOs apply their own criteria to assess the value, relevance and applicability of a product.

Maintaining honesty, transparency and appropriate communication is essential. The ultimate objective is to build trust and credibility — a foundation that benefits both the organisation and the wider healthcare community.

KOL management and development plans

A key medical affairs function is to establish scientific dialogue with existing KOLs and to identify and nurture emerging experts in the field. Companies often begin by engaging established KOL networks, while new KOLs naturally emerge through scientific collaboration and co-development of clinical or evidence-generation projects. Such activities should never be accidental — they must be carefully planned, strategically prioritised and executed in a structured, compliant and scientifically meaningful way.

Patient engagement

Patient engagement is a a powerful set of activities that supports a deeper understanding of disease, patient needs and real-world application of a project. It provides rich, practical insights into the lived patient experience and offer invaluable input for project refinement and future development. Patient groups and patient representatives are becoming increasingly influential — from advisory roles within companies to participation in regulatory bodies such as the EMA.

Well-designed and structured patient engagement significantly improve the relevance, impact and real-world value of a project, ensuring that development remains aligned with what truly matters to patients.

Scientific societies interactions

Scientific societies are an essential stakeholder, shaping much of the scientific understanding within a therapeutic area. Beyond traditional congress activities, societies offer numerous avenues for productive collaboration between a company and the broader scientific community.
Today, they operate across multiple domains – including clinical research collaborations (CRCs), educational initiatives, data dissemination , guideline development, interdisciplinary working groups and interactions with governmental bodies.

Maintaining strong connections with scientific societies enables the creation of meaningful collaborative projects and ensures alignment with the evolving scientific landscape.

Advisory boards

As in clinical development, medical affairs activities often require independent expert evaluation. Advisory boards bring together external specialists who can assess company projects and provide unbiased scientific and strategic guidance. To ensure high-quality outcomes, an advisory board must be carefully prepared and executed in a structured manner with professional moderation. This approach maximises the value of the discussion and leads to clear, actionable recommendations.

Publication plans

Scientific publications are a key component of medical affairs activities. They provide an opportunity to share scientific data transparently and to engage a wide range of stakeholders in meaningful scientific dialogue.
A well-structured publication plan ensures clarity on where, when and how the data will be communicated, and helps the company understand the potential reach, impact and scientific coverage of its evidence.

Real-World Evidence services

Outsourced Real-World Evidence deparment

We operate as your dedicated, full-service Real-World Evidence department, providing the scientific expertise, operational capacity and strategic leadership needed to deliver high-quality RWE across the entire product lifecycle.

Our model gives companies immediate access to RWE specialists — functioning as a seamless extension of your internal team. We design, execute and communicate real-world evidence that supports regulatory submissions, informs clinical and commercial strategy, and strengthens engagement with stakeholders.

With us as your external RWE function, you avoid the need for recruitment, internal coordination and infrastructure setup, while gaining focused therapeutic area experts who act as a flexible, scalable and cost-efficient evidence engine that adjusts to your evolving pipeline and market priorities.

Real-world evidence trials (RWE)

Real-world evidence (RWE) studies are typically classified according to the type of data they use:

• Primary data collection RWE
Studies in which new data are actively generated and collected according to a predefined protocol. This approach mirrors classical clinical trials but within a real-world context.

• Secondary data analysis RWE
Studies that analyse existing company-owned datasets, often derived from prior RWE activities, to address additional scientific or strategic questions.

• Tertiary RWE
The most common type of RWE study, based on external, routinely collected data such as electronic health records, medical claims, insurance databases and product or disease registries.

Evidence Opportunity Mapping

We help companies uncover where real-world evidence can create the strongest commercial and clinical impact. Through systematic mapping, we identify priority evidence gaps across the product lifecycle and convert them into a clear, actionable RWE roadmap.

Our approach aligns scientific opportunities with stakeholders expectations and competitive positioning. This ensures investment in evidence generation is focused, efficient and directly linked to value creation.

Real-World Patient & Clinical Pathway Insights

We generate deep, nuanced insights into real-world patient journeys and clinical practice using RWE, registry analysis, physician surveys and patient-reported data. This includes diagnostic patterns, referral flows, treatment sequencing, barriers to optimal care and moments of highest unmet need.

These insights form the backbone of differentiated value communication, more realistic forecasts and product strategies that reflect how medicine is really used in practice.

Pragmatic & Low-Interventional Real-World Studies

We design and operationalise pragmatic trials, low-interventional observational studies and hybrid clinical-real-world designs that capture effectiveness, safety, utilisation patterns and patient outcomes in routine care.

Our team ensures efficient ethics approval pathways, smart data collection methods and regulatory-aligned documentation (EMA/FDA expectations for RWE). The result is high-quality, decision-grade evidence that complements traditional clinical trials.

Evidence Communication & Scientific Engagement

We help companies translate real-world insights into clear, compelling narratives for clinicians, payers, HTA bodies and scientific audiences. This includes publication planning, manuscript development, congress abstracts/posters, value communication materials and cross-functional messaging.

We ensure that evidence is not only generated — but also seen, understood and used to drive clinical and commercial impact.

Why Clients Choose Us

Case Studies

Global pipeline analysis in respiratory diseases

We conducted a comprehensive assessment of more than 50 clinical-stage assets in asthma, COPD, CF, PAH and IPF for a Top-3 global pharmaceutical company.
Our work combined a deep scientific review with competitive intelligence, regulatory landscape analysis and mechanism-of-action comparison.

We evaluated trial designs, endpoints, inclusion criteria, biomarkers, safety signals, formulation and delivery platforms, and commercial differentiation potential across the US, EU and Asia.
Based on these insights, we identified strategic gaps, prioritised the most promising mechanisms and created an evidence-based portfolio direction to support R&D, medical and partnering decisions.

Strategic insights for the European Respiratory Society

We supported C-level leadership with a long-term strategic priority review for ERS.
This included designing and conducting 50+ in-depth interviews with key stakeholders: policymakers, clinicians, early-career researchers, scientific society leaders and industry representatives.

We analysed perceptions of ERS scientific output, education ecosystem, digital tools, advocacy role and the long-term vision for respiratory research in Europe.
Our insights shaped future directions for science & research programmes, education strategy, digital engagement pathways and multi-stakeholder collaboration models.

Real-world evidence programme for biotech company

We supported a biotechnology company in designing and delivering a multi-national real-world evidence programme, focused on understanding treatment patterns and patient burden.

Our work included development of the evidence generation plan, protocol design for prospective studies, and other relevant elements. We coordinated with research sites across different countries ensuring operational process and consistent data quality.

We worked closely with recruitment parties to optimise enrolment, improve feasibility and align the study with real clinical practice.

Investment evaluation in aesthetic medicine

For a consortium of private US investors, we assessed the full development pathway and investment attractiveness of a novel aesthetic-medicine technology.

Our work included defining the target product profile (TPP), mapping regulatory expectations across major markets, designing a realistic clinical development plan, modelling recruitment and operational timelines, and assessing manufacturing scale-up considerations.

We performed a risk–benefit and cost-of-capital analysis and built several valuation scenarios.
The final report enabled investors to refine their decision-making and negotiate evidence-based development milestones with the technology owners.

About us

Erinaco is a boutique consultancy founded by a medical doctor with more than two decades of experience in global pharmaceutical companies. We help organisations build scientific value for their medicines through strategic evidence generation, clinical development and medical affairs expertise. Our way of working is as a flexible extension of your team, combining strategic insight with hands-on delivery to advance products from concept to clinical practice. Our international background spans the EU, US, China and Japan, and includes experience working with the EMA, FDA and major respiratory societies.

Our goal is simple: to bridge science and practice, helping new therapies reach patients with measurable value.

  • 20 years of global pharma experience
  • Main focus – respiratory diseases
  • Evidence-first approach to strategy
  • Strong working relationships with leading KOLs and other stakeholders

Let’s Discuss Your Project

If you’re planning a study or designing an evidence strategy, we can support you at every step.

E-Mail: info@erinaco.it