Study Conduct at CIU

At the CIU (Clinical Investigation Unit), a dedicated team of Study Nurses, Coordinators, and Junior Research Assistants conduct on-site visits and manage study participant-related activities. This includes planning, coordination, and adherence to study protocols for all types of clinical research, particularly clinical trials and cohort studies.

We offer a flexible approach to meet your study needs: engage our on-site management team for the entire duration of the study conduct, choose a modular engagement, or bring your research team to our premises.

Located in the sitem-insel building, adjacent to the Inselspital, we foster close collaboration with Investigators and research teams. We offer clinical services within a dedicated, patient-friendly environment where clinical studies are our entire business, so attention to detail is front of mind.

Our six large dedicated patient rooms, each with its own bathroom, are ideal to run dedicated trial clinics, providing efficient and flexible spaces for screening, patient consenting, and study visits. Our laboratory is equipped with centrifuges, storage, fridges and -20 and -80 freezers, allowing easy transfer of biospecimens to Inselspital and external laboratories.

Our Services

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Study Planning and Set-Up
  • We assist in obtaining approvals
  • We support your internal study registration
  • We prepare and create study documents

Budgets
  • We prepare costings for the conduct of academic studies and support or take care of budget and budget-negotiations for industry studies.
  • We perform up-to-date controlling of our studies so that any necessary budget renegotiations can be carried out promptly.
  • We ensure that the budget negotiated with the industry covers our costs.

Patientmanagement
  • We assist in screening and enrolling suitable participants for your study, conducting pre-screening and eligibility checks.
  • We coordinate and schedule all study visits, including follow-up, ensuring punctual appointments for participants.

Study Visits
  • We handle the organization, coordination, and execution of all study visits, overseeing both 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, lung function tests, and others.
  • Administering surveys, whether paper-based, online, or conducted via telephone.
  • Collecting, processing, storage, and shipment of biological samples
  • Dispensing and administering investigational medicinal products and assisting study participants with the use of medical devices.
  • Documenting study data in Case Report Forms

Safety Management
  • Identifying, documenting, and reporting adverse events
  • Timely identification and documentation of Adverse Events.
  • Maintaining communication channels with investigators to address any safety concerns promptly.

Drug Accountability
  • Dispensing investigational drugs according to the protocol.
  • Managing inventory, including storage and monitoring expiry dates.
  • Documenting drug administration details.
  • Monitoring participant compliance and addressing non-compliance.

Management of Biological Samples
  • Collecting biological samples from study participants according to the trial protocol and standard operating procedures (SOPs)
  • Handling and processing biological samples in a laboratory setting
  • Ensuring proper 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.
  • Maintenance of the Investigator Site File