Crossover Clinical Research Units (CRUs) are purpose-built, dedicated and exclusive clinical research facilities located at healthcare institutions. Each unit is a "one-stop shop" designed to provide sponsors and CROs with an exemplary service in clinical trials. Each CRU is:

• a true partnership between Crossover and a centre of healthcare excellence, utilising Crossover's unparalleled expertise in running and delivering clinical trials
• staffed by experienced and trained Crossover clinical research personnel whose ONLY responsibilities in the healthcare institutions are directed at optimising clinical trial management and delivering high quality clinical trial data
• the only facility in the institution in which trials are performed, thus concentrating expertise and ensuring consistency of operations across all the clinical/therapeutic disciplines engaged in clinical research
• equipped with state-of-the-art facilities for ensuring that full compliance with ICH-GCP and IND regulations is maintained managed and led by an internationally experienced senior clinical research management team

Structure of CRUs
Each CRU is headed by a CRU manager who provides support, training, mentoring, quality control and technical expertise to a team of professional staff with skill sets in:

• Clinical trials site management and co-ordination
• Pharmacy and drug supplies management
• Regulatory affairs
• Use of clinical trial technologies
• Document management and archiving
• Quality assurance
• Good clinical practice (GCP) training

Responsibilities and activities of the CRU
As the dedicated clinical research facility at the healthcare institution, each CRU deals with all aspects of the clinical trial that are not directly concerned with immediate clinical management of the individual patients. Specifically:

Initial contacts with sponsor/CRO
Feasibility – Rapid assessment and feedback of the ability of the healthcare institution to conduct a clinical protocol. This is objectively corroborated in collaboration with study investigators and hospital technical and facilities staff.

Protocol review and assessment – Medical and scientific review is, of course the prerogative of the Principal Investigator and other clinicians; CRU personnel assess the technical and operational tasks and challenges and work with the sponsor/CRO to ensure that the study "flows" and operational tasks are organised ahead of time.

Financial management – Including provision of costing, negotiation of budgets and contracts, reporting, invoicing and tracking of out-of-pocket expenses.

Study preparation

• Preparation of all documentation to the Ethics Committees/IRBs, including translations and submissions (via the principal investigator).
• Attendance at Investigators’ Meetings
• Preparing study logistics task charts/workflow
• Working with IT to ensure optimal functioning of EDC
• Detailed review of the CRF/electronic data capture (EDC) systems
• Arrangements for the receipt, storage, disposition, accountability and destruction of clinical drug supplies; liaison with healthcare institution pharmacy
• Contacting referral centres alerting them to the study and patient entry criteria
• Establishing courier services for transport of samples, case report forms (CRFs), study materials, etc.
• Establishing and maintaining site files and providing pre-study documentation to sponsor/CRO

Study conduct

• Contacting patients (for prevalence studies)
• Setting up patient appointments, issuing letters and following up with calls, organising patient transport and expenses (where appropriate)
• Ensuring that the principal investigator, other staff, facilities, equipment, records and CRFs are available for each patient visit
• Liaison with healthcare institution laboratories, external laboratories and other clinical departments for routine and study specific investigations
• Completing lab forms for principal investigator sign-off, liaising with the lab, ensuring results come back, are reviewed and added to the records
• Completion of reporting forms; obtaining principal investigator sign-off per sponsor and regulatory requirements
• Transcribing data to the CRF or EDC; obtaining principal investigator sign-off as per sponsor needs, copying and shipping to sponsor/CRO
• Review of healthcare institution records for serious adverse events (SAEs)
• Ensuring all data are recorded/retained in the records
• Checking drug and other supplies for the patients, liaising with healthcare institution pharmacy
• Preparing for and attending sponsor/CRO routine monitoring and medical management visits, dealing with and resolving issues
• Updating sponsor/CRO by phone, email, fax and via project management systems on status of study
• Regular reminders sent to referring departments and physicians

Study closure

• Receipt and resolution of data clarification queries and return to sponsor/CRO
• Handling all aspects of study close-out, shipment of CRFs/data clarification forms (DCFs)/study files, archiving/disposition and accountability, destruction of clinical supplies/liaison and updating of Ethics Committee/IRB)
• Preparing for and attending sponsor/CRO quality assurance audits and visits, dealing with and resolving issues
• Preparing for and attending regulatory inspections and visits, dealing with and resolving issues