Services
Services That Help You Succeed
Explore how our clinical and regulatory expertise supports your research at every stage. Each section highlights the key ways we help teams move forward with clarity, compliance and efficiency.
We develop comprehensive clinical development roadmaps that provide a structured, evidence‑based pathway from concept to study initiation. Our approach integrates feasibility assessment, methodological considerations, regulatory prerequisites and operational planning. We define critical decision points, interdependencies, documentation workflows and resource allocation strategies to ensure a controlled, compliant and efficient project start‑up.
We prepare, review and coordinate all regulatory documentation required for clinical investigations, ensuring alignment with EU and national regulatory frameworks. This includes the compilation of submission dossiers, preparation of Investigator’s Brochures, IMPD/IB updates, device‑specific MDR documentation, risk management files and safety reporting structures. We manage interactions with Ethics Committees and Competent Authorities, ensuring that submissions are complete, technically robust and compliant with applicable legislation, thereby reducing the likelihood of delays or requests for clarification.
We provide specialised regulatory and clinical support for Horizon Europe, IMI, EIT Health and other EU‑funded initiatives. Our expertise covers the integration of clinical and regulatory requirements into work packages, deliverables and project governance structures. We support the preparation and quality assurance of clinical‑related deliverables, ensure alignment with EU reporting obligations, coordinate multi‑partner regulatory activities and facilitate communication with project officers and oversight bodies. This service strengthens compliance, harmonisation and operational coherence across international consortia.
We offer operational oversight and methodological guidance to ensure high‑quality study execution across all sites. This includes monitoring plans, site management strategies, operational SOPs, data handling workflows and quality oversight mechanisms. We support risk‑based monitoring, deviation management and protocol/GCP adherence throughout the study lifecycle.
We ensure that clinical activities adhere to Good Clinical Practice (GCP), the Declaration of Helsinki, EU Clinical Trial Regulation (CTR) requirements, MDR obligations and national ethical standards. Our support includes compliance audits, documentation reviews, ethical risk assessments, preparation for inspections and implementation of corrective and preventive actions (CAPA). This service helps organisations maintain regulatory integrity and minimise compliance‑related disruptions.
We act as an interface between research teams, institutional bodies, Ethics Committees and Competent Authorities. Our role includes preparing briefing materials, coordinating regulatory communications, aligning expectations across stakeholders and ensuring that scientific, operational and regulatory perspectives remain synchronised. This reduces procedural delays, improves clarity in decision‑making and enhances the overall efficiency of regulatory interactions.
We provide technical support in data management and statistical analysis to ensure methodological rigour and regulatory‑ready outputs. This includes database design and configuration (e.g., REDCap), data validation workflows, statistical analysis plans (SAP), data cleaning procedures and SPSS‑based analyses. We assist in generating descriptive and inferential statistics, preparing analysis summaries for regulatory submissions and ensuring that data structures meet audit and traceability requirements.
We provide financial governance and audit‑readiness support for clinical studies and EU‑funded projects. This includes budget structuring, cost‑tracking frameworks, financial risk assessment, eligibility verification and compliance with EU financial regulations. We assist in preparing audit documentation, ensuring traceability of expenditures, validating cost‑justification narratives and supporting interactions with auditors and funding bodies. This service strengthens financial transparency, accountability and compliance across the project lifecycle.