TEDDY provides specialised methodological consulting to ensure that paediatric clinical trials are conducted and reported according to established international standards: 

• SPIRIT-children, a paediatric-specific extension of the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement. 
• CONSORT-children, a paediatric-specific extension of the CONSORT (Consolidated Standards of Reporting Trials) statement.

This service aims to improve the clarity, replicability, and overall quality of paediatric clinical trial protocols and reports, leading to more effective and safer treatments for children.

What TEDDY offers

• Evidence-based recommendations for the structure of study protocols and CSRs. 

• Collaboration with study teams to ensure compliance with standards. 

• Access to shared documentation platforms, regular updates, and reference management systems. 

TEDDY guides the process of designing a paediatric clinical trial with Clinical Data Interchange Standards Consortium (CDISC) standards, a strategic approach that integrates data standardization from the earliest stages of the study to ensure data quality, traceability, and regulatory compliance. 

This service provides methodological support for the standardization and harmonization of paediatric clinical trial data.  

What TEDDY offers

• Case Report Form (CRF) design and data acquisition using Clinical Data Acquisition Standards Harmonization (CDASH). 

• Expertise in converting raw data into Study Data Tabulation Model (SDTM) datasets, which follow the SDTM Implementation Guide (SDTMIG) specifications.   

• Analysis Data Model (ADaM) standard to create analysis datasets. 

Key tools: 

CDISC standardization relies on software and computing infrastructure, including electronic data capture (EDC) systems, statistical programming platforms, and clinical database design software. 

Our service supports healthcare  organisations, research institutes, and life sciences companies in enabling the secondary use of health data through advanced anonymisation and dataset validation processes. 

We make clinical datasets reusable for research, innovation, and technological development, while ensuring the highest level of patient privacy protection and full compliance with European and international regulations. 

Data is considered anonymized only when no individual can be identified by any reasonably available means. Effective anonymization must prevent single-out, isolating an individual within a dataset, likability, linking anonymized data with other datasets to re-identify a person, and inference, inferring new personal information from anonymized data. When these risks are eliminated, the process becomes irreversible and the data falls outside the GDPR.  

In healthcare, robust anonymization enables the secure secondary use of clinical data for research, AI development, realworld evidence, and innovation. Our service applies advanced anonymization and rigorous validation to help organizations safely reuse and share health data while minimizing reidentification risks and maximizing data value.  

What TEDDY offers: 

Anonymization of Health Data 

• Preliminary dataset assessment, including analysis of structure, variables, and data content.

• Identification of direct identifiers and quasi-identifiers that may enable re-identification.

• Design of a tailored anonymization strategy aligned with the intended secondary use (e.g., research, AI development, population analytics).

• Application of advanced anonymization techniques, such as: pseudonymization, data generalization,  selective suppression, data perturbation, statistical models (e.g., k-anonymity, l-diversity, t-closeness).

The result is an anonymized dataset that preserves scientific and analytical utility, making it suitable for research, advanced analytics, and innovation initiatives. 

At the core of the service is a customized Development Plan, structured into independent yet interconnected sections. Each section addresses a critical aspect of pediatric therapies and is specifically designed to offer targeted support based on the unique characteristics of the product and the regulatory environment. This approach ensures both flexibility and scalability, while maintaining a cohesive, end-to-end development strategy. 

Each stage of our process is designed to address key aspects of development, providing tailored support that reflects the unique features of the product and the regulatory requirements.
This approach ensures flexibility and adaptability, while maintaining a consistent, end-to-end strategy that guides the project from start to finish. 

What TEDDY offers  

The Service offered is the support in the design, compilation and adjourning of the document for a specific  Paediatric Advanced Therapy, including the key phases of product development, from pre-clinical study references, national and international (EMA-FDA), clinical trial authorization, and clinical trial marketing authorization. 

• Medical Need & Product Definition 

• Product Description & Technical Profile 

• Market Analysis 

• Translational & Preclinical Strategy 

• CMC – Chemistry, Manufacturing & Controls   

• Definition of Quality System & Compliance requirements   

• Clinical Development Pathway for specific therapy   

• Regulatory Roadmap Definition   

• Health Technology Assessment (HTA) for specific therapy Risk Management & Procurement Strategy 

• Intellectual Property & Competitive Landscape 

• Timeline to Marketing Authorisation (MAA) 
• References:
  • • Scientific publications
    • Regulatory guidance (EMA/FDA/ICH)
    • Data sources used throughout the plan

To perform a correct and rapid development of a new Medical Device from basic science to CE Marking is a good practice to create a “Development Plan”, a live document that summarizes all steps required and the scientific and economic parameters at any moment.

Each stage of our process is designed to address key aspects of development, providing tailored support that reflects the unique features of the product and the regulatory requirements.
This approach ensures flexibility and adaptability, while maintaining a consistent, end-to-end strategy that guides the project from start to finish.

What TEDDY offers

The Service offered is the support in the design, compilation and adjourning of the document for a specific Medical Device, including the key phases of product development, from pre-clinical study references, national and international (EMA-FDA), clinical trial authorization, and CE Marking.

• Medical Need & Product Definition

• Product Description & Technical Profile

• Market Analysis

• Translational & Preclinical Strategy

• CMC – Chemistry, Manufacturing & Controls

• Definition of Quality System & Compliance requirements

• Clinical Development Pathway for specific Medical Device

• Regulatory Roadmap Definition

• Health Technology Assessment (HTA) for specific Medical Device

• Risk Management & Procurement Strategy

• Intellectual Property & Competitive Landscape

• Timeline to Marketing Authorisation (MAA)

• References:

• • Scientific publications
  • Regulatory guidance (EMA/FDA/ICH)
  • Data sources used throughout the plan

To define a proper, straightforward and time-saving Design & Development of a new Medical Device or an IVD from basic science to CE Marking is a good practice to create a “Development Plan”, a live document that highlighted all design control steps required as well as the scientific and economic efforts at any moment.

Each stage of our process is designed to address key aspects of development and market access, providing tailored support that reflects the unique features of the product, the regulatory requirements to be met and the market needs.
This approach ensures flexibility and adaptability, while maintaining a consistent, end-to-end thorough strategy that guides the project from start to finish.

What TEDDY offers 

The Service offered is the support in the design, compilation and adjourning of the document for a specific class III implantable MD or an IVD, including the key phases of product design & development, from pre-clinical study references, national and international (EMA-FDA), clinical investigation authorization, Notified Boby engagement and CE Marking.

Our comprehensive overview ensures full compliance with the MDR/IVDR, applicable Standards and Common Specifications obligations.

• Clinical and User’s Needs Definition
• User-Centered Product Design
• Product Description & Technical Profile
• Market Analysis
• Translational & Preclinical Strategy
• Definition of Quality Assurance System & Compliance requirements
• Clinical Development Pathway for specific Medical Device
• Regulatory Roadmap Definition
• Technical Documentation and Design Master file
• Health Technology Assessment (HTA) for specific Medical Device
• Risk Management & Procurement Strategy
• Intellectual Property & Competitive Landscape
• Timeline to Conformity Assessment under MRD/IVDR
• References:
  • Scientific publications
  • Official  guidelines & KOL feedback
  • Regulatory guidance (MDR/IVDR/EMA/FDA/ICH)
  • Data sources used throughout the plan

This service promotes the active involvement of Young Person Advisory Groups (YPAGs) within TEDDY KIDS Network in all phases of paediatric research projects. The objective is to systematically integrate young people’s perspectives and preferences into research processes, in order to enhance the relevance, quality, and meaningfulness of research for the youth population. 

TEDDY establishes and supports YPAGs within TEDDY KIDS Network to create opportunities for meaningful participation and ensure their input is reflected in research decisions. Young people actively contribute to shaping research questions, methods, and outcomes, ensuring that studies reflect their real needs and priorities.  

This patient‑centred approach ensures that research outcomes are more closely aligned with young people’s real needs and priorities, thereby increasing their relevance, practical applicability, and overall impact for the target age group. 

What TEDDY offers  

• Designing surveys aimed at collecting structured feedback on specific research topics and reviewing key study documents. Surveys are developed in a format tailored to young people, ensuring clarity, accessibility and age-appropriate language. Surveys may include a combination of closed and open-ended questions, scenario-based questions, and rating scales to capture the perspectives, preferences, and levels of understanding of young participants. This approach supports the identification of potential barriers, improves the relevance and usability of research materials, and provides useful information for making improvements during project development. 

• Educational materials specifically developed in co‑design with young participants to ensure clarity, accessibility, and relevance. These resources are designed to support their understanding of study objectives, methodologies, and patient‑centred outcomes, thereby empowering young people to contribute meaningfully and confidently throughout the research process. 

• Communication content to enhance scientific knowledge dissemination within paediatric communities the research process, including the creation of informative materials children-friendly including apps, videos, and printed materials related to the project.  

• Engagement reports that document young people’s contributions, describing activities carried out, roles assumed, decisions influenced, and the impact on the study, enriched with testimonials and qualitative insights. 

• Brief reports or summaries that describe how young people (or patients) have been involved and empowered in the research process. 

Key tools: 

The creation of child-friendly informative materials, including educational apps, instructional and informative videos, printed resources, detailed reports, and clear summaries, all designed to effectively communicate complex information in an accessible and age-appropriate manner, is developed using advanced digital solutions and collaborative platforms such as Microsoft Office and Google Workspace. 

This service is dedicated to making complex paediatric research understandable and impactful for young people, families, and the wider community. TEDDY is committed to ensuring that research findings are communicated clearly, rigorously, and meaningfully. 

TEDDY provides a specialized communication and dissemination service with a strong focus on the clear and effective presentation of scientific content.

Activities include: 

Scientific communication for stakeholders and interdisciplinary communities, designed to translate research findings, clinical evidence, and complex data into accessible and accurate materials. 

Scientific communication aimed at the general public, including content appropriate for children and young people, which converts concepts from biomedical and clinical research into educational messages that are engaging and age appropriate. 

What TEDDY offers: 

• Clear communication: ensuring that research findings are presented accurately and meaningfully for audiences of all backgrounds. 

• Creation and Support for outreach: creating informational materials, awareness campaigns, and communication tools tailored to diverse audiences. 

• Social impact: promoting the dissemination of scientific knowledge to improve awareness and engagement across the community. 

• Making pediatric research accessible by translating and simplifying complex information for both young audiences and professionals. 

• Organization of workshops and events to foster connections among researchers, families, young audiences, and experts.  

Key tools: 

TEDDY use a variety of tools to ensure effective communication and engagement –  graphic design tools like Canva, video editing software, to produce multimedia content. 

For online workshops and events, we use platforms like Zoom and Microsoft Teams. 

For community engagement, we use interactive platforms for quizzes, surveys, and educational apps.

This service aims to integrate young people’s perspectives into ethical and data protection processes, ensuring that materials, procedures and decisions are comprehensive, age-appropriate and respectful of the children involved in research. 

The activity involves YPAGs within the TEDDY KIDS Network and focuses on reviewing key documents relating to data use, biological samples and privacy. 

TEDDY facilitate discussions with YPAGs to understand their comfort levels and preferences regarding data and sample handling, incorporating these insights into our ethical frameworks and operational procedures.  

What TEDDY offers: 

• Revision of information materials in collaboration with YPAGs: analysis of consent/assent documents; assessment of language clarity, transparency and content consistency; collection of suggestions to make materials clearer and more suitable for minors.  

• Evaluation of data management processes: organisation of meetings with young people and experts in the field to discuss the concerns perceived by minors (transparency, risk, trust). Collection, use, sharing and storage of data. Identification of potential concerns perceived by minors (transparency, risk, trust). 

• Co-development of child-friendly ethical and privacy recommendations: co-creation, together with YPAGs, of operational guidelines or checklists to be applied in biomedical research projects and clinical trials. 

• Reporting and integrating young people’s contributions on ethical and privacy issues in research projects and clinical trials: preparation of structured reports that include YPAG feedback, recommendations and results shared with researchers and ethics committees (where applicable). 

• Provides specialized training for healthcare professionals through direct engagement with young people and offers specific education for children on national and international guidelines, led by subject-matter experts. 

Key tools: 

TEDDY uses secure digital platforms, such as Microsoft Forms and Google Forms, for data and consent collection, and SharePoint for secure internal archiving. This ensures efficient document management, data protection, compliance, and confidentiality throughout the entire process.

This service focuses on understanding the future landscape of paediatric therapeutics by analyzing medicines currently in clinical development and identifying emerging unmet needs.  

Through full access to relevant clinical trial and pipeline data from a variety of sources, including public registries, scientific literature, and collaborations, the service delivers a range of valuable outputs to support decision-making in  paediatric  therapeutics. 

What TEDDY offers  

• Detailed analytical reports on paediatric therapeutic pipelines, offering insights into ongoing developments. 

• Forecasts of therapeutic trends to anticipate future directions in treatment.  

• Strategic guidance to assist with research and development planning.  

• Customised datasets and interactive visual dashboards, allowing users to explore and interpret the data effectively. 

Key tools: European Paediatric Medicine Database (EPMD) 

EPMD is an on-line database set up in 2007 in the framework of FP6 TEDDY Project with the aim of creating a harmonised, integrated, and reliable pan-European source of information on all paediatric  medicines registered under the European Medicines Agency (EMA)  Centralised  Procedure.  

For each medicinal product, it provides details on therapeutic indications, dosage, approved age groups, and related clinical studies. The database includes years  of authorisation, active substance, brand name, Anatomical Therapeutic Chemical (ATC), classification code, and orphan designation status. Additional features are available upon request, including regulatory details such as the  Paediatric Investigation Plan (PIP),  paediatric variations, product type (chemical, biological, advanced therapy medicinal products – ATMPs), and regulatory status (new product, variation, or repurposed medicine).  

The service aims to support clinicians and researchers at paediatric clinical centres,  consortia and paediatric research institutes in the implementation of high-quality processes to ensure that clinical research conducted in paediatrics complies with high standards of quality, safety and scientific integrity.  

TEDDY supports and facilitates the setting up of a paediatric clinical research quality system through the definition of clear and transparent governance. This includes  identifying roles and responsibilities within the research team, creating appropriate decision-making channels and implementing internal supervision processes. The service ensures that every phase of research, from design and conduct to monitoring and data and results management, is consistent with the principles of Good Clinical Practice (GCP) and specific European and international regulations. 

What TEDDY offers:  

• Advisory support to ensure compliance with quality system requirements in accordance with international standards, European regulations and ethical considerations. 

• SOP management, including creation, periodic review and update controls. 

• Training of personnel working on paediatric clinical trials on GCP, paediatric regulations (such as ICH E11 and EU Paediatric Regulation), and best practices for effective communication with children and families. 

• Paediatric Informed Consent management, including support in developing age-structured templates, consent procedures, and child-friendly information materials. 

• Monitoring of Key Performance Indicators (KPIs) including mean time to SOP approval, percentage of audits completed on time, major/minor deviation rate, percentage of staff trained and certified.

• Support in planning the annual quality plan, strategic objectives, and periodic system reviews. 

Key tools  

The service can be based on the use of an e-learning training platform.

This service focuses on transforming Real World Data (RWD) into high quality, actionable Real World Evidence (RWE). By combining rigorous systematic literature reviews with advanced meta-analyses, we deliver clear, credible insights that empower companies, regulators, and healthcare organizations to make confident clinical, regulatory, and strategic decisions. Real-world evidence derived from non-interventional studies (NIS) is essential for assessing drug effectiveness in pediatric population and rare diseases, where traditional randomized controlled trials (RCTs) are often challenging, unethical, or infeasible due to small patient populations. 

Designed for companies, regulators, and healthcare organizations.   This service focuses on transforming Real World Data into powerful, decision ready Real World Evidence, accelerates your strategic, clinical, and regulatory goals through high quality systematic literature reviews and advanced meta-analysies The service is critical for enabling data-driven decisions, supporting regulatory submissions, and guiding clinical and strategic policy actions. 

We can help your institution to identify and synthesize the most relevant data, turning complex information into clear, credible insights.  

What TEDDY offers  

• Systematic Literature Reviews (SLRs) : We identify and evaluate the most relevant scientific evidence using internationally recognized standards. 

• Advanced Meta‑Analyses : We synthesize data across studies to provide clear, quantitative insights that strengthen your decision‑making.