STUDY DEVELOPMENT

• Notification of First Enrolment to the EC/AC

  We4 Clinical Research can notify the Ethics Committee (EC) and/or Competent Authority (AC) about the first enrolment of the study. This notification ensures that the relevant regulatory bodies are informed and updated on the study's progress.

• Data Management & Cleaning

  We4 Clinical Research provides comprehensive data management services throughout the study. This includes effective tools and processes for data cleaning, ensuring the accuracy and consistency of the study data. We employ robust data management practices to maintain data integrity and facilitate data analysis.

• Remote Data Entry Verification

  We4 Clinical Research ensures that data entry is conducted accurately and efficiently, adhering to established protocols and guidelines, via periodic gap analyses and consistency checks; it represents a fundamental step that assures a continuous overview throughout the study and guarantees a proper preparation of the data for interim statistical analysis and monitoring visits.

• Remote and on-site Monitoring Visits

  We4 Clinical Research conducts monitoring visits either remotely or on-site to ensure the study's proper execution. These visits are performed in accordance with the protocol, monitoring plan, Good Clinical Practice (GCP), and relevant principles. We monitor study activities, data quality, and compliance with regulatory requirements.

• Amendments to study documentation

  We4 Clinical Research manages protocol amendments to facilitate their speedy approval and implementation. Our team updates the required documentation and ensures that the amendments align with regulatory guidelines and study objectives.

• Newsletters

  We4 Clinical Research prepares and distributes newsletters to communicate updates on the study's progress. These newsletters serve as a means to highlight relevant updates, share significant milestones, and keep all stakeholders informed and engaged.

• Interim Report

  We4 Clinical Research has the capability to generate and review interim reports for the study. These reports provide a snapshot of the study's progress, including key findings, data trends, and any necessary recommendations for adjustments or improvements.

• Investigator Meetings

  We4 Clinical Research assists the Sponsor in scheduling and organizing Investigators' Meetings during the study progress, if deemed worth by the sponsor. We contribute to creating presentations and inviting guests, facilitating effective communication and collaboration among investigators and study team members.