Study Implementation

Eurotrials provides research and development services, acting in all the steps of the R&D process, until the product reaches the Market. The process could be for the development of new drugs, new therapeutic solutions, medical devices or new methods for clinical diagnosis.

One of its main activities is the design and implementation of clinical research projects, an important part of the product development process.
Our commitment lies in breaking down research barriers and finding creative solutions, assuring quality and innovation in our services for study implementation.

Study Design

  • Research methodoly consultancy;
  • Product development consultancy;
  • Clinical study design;
  • Synopsis and protocol development;
  • Calculation of sample size;
  • Sample definition and stratification;
  • Case report form design / review and production;
  • Informed consent development;
  • Other patient documents development, eg diares;
  • Development of study support materials;
  • Investigational Medicional Product Dossier (IMPD) development;
  • IT solutions for data capture (web portal, PDA);
  • Expert panels / advisory boards;
  • Master CRF;
  • Literature research for systematic review purposes.

Planning & Preparation

  • Database design, implementation, administration and validation (according to FDA21 CFR Part 11, CDISC-CDASH, STDM);
  • Web portals development;
  • Feasibility studies;
  • Investigation sites identification and selection;
  • Pre-study, starting monitoring and closing visits;
  • Preparation of data handling manuals;
  • Case report form design / review and production;
  • Documents preparation:
    • Synopses / Protocol translation;
    • Informed Consent customization;
    • Financial Agreements;
    • IMP Label content revision.

Submission & Implementation

  • Managing investigators’ meetings;
  • Training of research teams and CRAs;
  • Obtaining Study Documentation (i.e. Study Insurance);
  • Regulatory Submissions/Study submission to competent authorities;
  • Investigational Medicinal Product Management (ex. Packaging, Stock managing);
  • Study initiations visits.

Conducting

  • Centralized Project Management;
  • Monitoring visits;
  • Investigational Medicinal Product Management;
  • Data validation and data monitoring (query generation and tracking);
  • Data coding (MedDRA and WHO-ATC);
  • Data transfer (import and export);
  • Quality control;
  • Interim exploratory and post-hoc analyses;
  • Medical revision;
  • Pharmacovigilance;
  • Data conciliation.

Submission & Implementation

  • Centralized Project Management;
  • Close-out visits;
  • Investigational Medicinal Product Management;
  • Data transfer (import and export);
  • Quality control.

Analytics & Reporting

  • Clinical/Safety reports;
  • Final Report/Presentations/Posters;
  • Clinical study reports (CSR) according to the applicable ICH guidelines and regulatory requirements;
  • Data preparation for submission to Regulatory Authorities;
  • Subject data listings and descriptive statistics;
  • Safety data management and reporting;
  • Statistical Software used is SAS or SPSS;
  • Statistical reports;
  • Preparation and submission of scientific articles (original paper, reviews and others);
  • Meta-analyses.