Study Conduct at CIU

The CIU (Clinical Investigation Unit) provides operational support for the conduct of clinical research at the site level. A dedicated team of Study Nurses, Coordinators, and Junior Research Assistants supports investigators in the practical implementation of clinical trials. This includes, at the local site, site start-up activities, operational implementation throughout the entire study, and the planning and execution of study visits in accordance with the study protocols, GCP, and local regulatory requirements.

CIU services are available through a flexible engagement model, covering the full duration of study conduct or modular support tailored to the needs of the investigator and sponsor.

CIU is located in the sitem-insel building adjacent to the Inselspital, enabling close collaboration with Investigators and research teams. We offer clinical services within a dedicated, patient-friendly environment. Our six dedicated patient rooms, each with its own bathroom, are ideal for running trial clinics, providing comfortable spaces for screening, participant consenting, and study visits. Our laboratory is equipped with centrifuges, storage, refrigerators and -20 and -80 freezers, allowing temporary storage and transfer of biospecimens to Inselspital core facilities or external laboratories.

Our Services

-

Study Planning, Set-Up & Conduct
  • Supporting site start-up activities and readiness prior to study initiation, including study registration and internal approval at Inselspital.
  • Preparing and maintaining site-level study documentation (e.g., site-specific standard operating procedures (SOP), participant visit log) to ensure operational readiness of the site.
  • Serving as the site-level operational contact for the sponsor during study set-up and conduct and ensuring continuous site operability throughout the entire study.

Budgets
  • Assessing and developing site-specific budgets based on protocol-required procedures, including conducting and supporting budget negotiations with sponsors for industry-sponsored studies.
  • Monitoring and controlling study-related activities performed at the local site to ensure budget adherence and providing timely input to support budget adjustments or renegotiations throughout the study.

Participant Management
  • Conducting pre-screening and eligibility checks.
  • Assisting in screening and enrolling suitable participants.
  • Coordinating and scheduling all study visits, ensuring punctual appointments.
  • Serving as a primary contact point for study participants on visit-related questions.

Study Visits
  • Preparing and conducting study visits, including all pre- and post-visit tasks.
  • Collecting and recording study data according to protocol requirements, including conducting clinical assessments and various diagnostic procedures such as blood sampling and lung function tests.
  • Administering surveys, whether paper-based, online, or conducted via telephone.
  • Collecting, processing, storing, and shipping biological samples.
  • Dispensing and administering investigational medicinal products and assisting study participants with the correct use of medical devices.
  • Documenting study data in source documents and Case Report Forms.

Safety Management
  • Identifying, documenting, and timely reporting adverse events to the sponsor.
  • Informing the investigator of safety-relevant findings.
  • Supporting the investigator in completing safety reporting forms and gathering required documentations.

Investigational Products Management
  • Dispensing investigational products (IP) according to the protocol.
  • Instructing participants on the correct use of study devices.
  • Managing IP inventory at the local site, including storage and monitoring expiry dates of the IP.
  • Documenting IP administration, returns, and destruction details on the accountability logs.
  • Monitoring participant compliance and addressing non-compliance.

Management of Biological Samples
  • Collecting biological samples from study participants according to the protocol and SOPs.
  • Processing biological samples (e.g., centrifugation, aliquoting) in a laboratory setting.
  • Ensuring proper documentation and storage conditions for biological samples.
  • Preparing biological samples for shipment.

Record Keeping
  • Maintaining accurate and up-to-date records of study activities, participant enrollment, and data collection.
  • Maintaining the Investigator Site File.
  • Ensuring documentation readiness for monitoring visits, audits, and inspections.