Our Research Unit
City Site is situated in the heart of Stockholm at Hötorget. Studies that can be performed via outpatient clinics or primary care centres can with advantage be run from the centre. Flexible opening house guarantee study subjects a high degree of accessibility.
Staff
City Site is staffed by experienced research nurses with a solid understanding of GCP. Operations are regulated by the steering document – Standard Operating Procedures (SOP). Regular quality audits are performed by the QA section at A+ Science.
Principle Investigators / Co-Investigators are engaged on a consultancy basis as and when required, according to the type of assignment.
Equipment
The following is standard at the site. When necessary to meet clients’ requirements, additional equipment can be made available.
- Sphygmomanometers.
- ECG.
- Blood testing equipment including cool and cold (-20°) storage. A primary blood bank has been set-up for the unit. Local analyses are performed at Karolinska University Laboratory.
- Cold storage for pharmaceuticals.
The Case Records System
At City Site we use the electronic case record system ErgoMed. ErgoMed fulfils all the requirements set out by the authorities for a case record system (personal login, audit trail and back-up). In addition, since the monitor is given access to patients included in the study at hand only, the case record system makes it possible to carry out Source Data Verification (SVD) directly via a computer screen.
Safety
The clinic has a fully equipped emergency bag and a defibrillator. All our research nurses are trained in Cardiopulmonary resuscitation (CPR). All patients/study subjects are covered by our patient insurance policy.
Archiving
During a study, all study documentation is kept in locked filing cabinets. For long-term storage, documents are sent to an authorised records management company and stored in accordance with the client’s wishes.