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• TMF preparation and maintenance

  We4 Clinical Research sets up and maintains the Trial Master File (TMF) throughout the entire study duration. The TMF serves as a comprehensive repository of essential study documents and records. We ensure that the TMF is established and maintained according to regulatory requirements, facilitating efficient document management and inspection readiness.

• ISF preparation and forwarding

  We4 Clinical Research supports the setup and forwarding of the Investigator Study File (ISF) to clinical sites. The ISF contains essential documents and records specific to each investigator and site involved in the study. We ensure that the ISF is properly prepared, organized, and forwarded to sites, promoting compliance and documentation integrity.

• Preparation and submission of Documentation for Ethics Committee (EC) and Competent Authority (CA)

  We4 Clinical Research assists in preparing and submitting the necessary documentation for approval by local and/or central Ethics Committees (EC) and Competent Authorities (CA). We ensure that the documentation meets the regulatory requirements and facilitate the approval process on behalf of the Sponsor.

• Notification to Competent Authority (for post-market Studies with medical devices)

  We4 Clinical Research can notify the Country’s Competent Authority for submission and approval of the post-market studies.

• Contract Negotiation

  We4 Clinical Research assists the Sponsor in drafting and negotiating the Clinical Trial Agreement (CTA) with sites and other involved institutions. We ensure that the CTA reflects the study requirements, protects the interests of all parties involved, and complies with regulatory and legal considerations.

• Investigators’ Meetings

  We4 Clinical Research assists the Sponsor in scheduling and organizing Investigators' Meetings in the early and crucial stages of the study. We contribute to creating presentations and inviting guests, facilitating effective communication and collaboration among investigators and study team members.

• Good Clinical Practice and other certifications

  We4 Clinical Research verifies the qualifications of investigators and supports staff by checking their credentials. We also provide guidance on obtaining and maintaining GCP Certification efficiently. We ensure that all relevant personnel involved in the study meet the necessary training and certification requirements.

• Site Initiation Visit (SIV) preparation and execution

  We4 Clinical Research's staff prepares training materials and conducts Site Initiation Visits (SIV). These visits serve as an opportunity to train site personnel on study procedures, protocols, and regulatory requirements. We ensure that sites are adequately prepared to initiate the study and adhere to the necessary guidelines.

• Investigational Medicinal Product (IMP) and Medical Devices (MD) Management

  We4 Clinical Research can support the Sponsor to manage IMP/MD throughout the study. We coordinate with distributors to ensure that research sites have the necessary investigational products for the trial. We can monitor aspects such as expiration dates, usage, and retrieval of investigational products, ensuring their proper management and compliance with regulatory requirements.