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Services Offered

Clinical Trials Management
Management of Clinical Projects from A to Z. Entire projects or various components can be delivered. This includes (but is not limited to):

project management
protocol writing
feasibility studies
site selection
applications to authorities
financial agreements
recruitment plans
risk managment plans
investigator's meetings
site activation
study conduct
monitoring
data management
statistical analyses
closing
reporting

Non-Interventional Studies (NIS)
Providing the right level of monitoring and quality assurance.

Quality Compliance Projects
Follow-up of care programs, investigations, treatment regimens for health care providers or others.

Medical Writing
Authoring of Clinical Protocols, Clinical Study Reports, Study Summaries, Expert Reports, Abstracts, and Publications.

Medical Devices
Planning and accomplishment of literature searches and writing of literature search protocols and reports as well as clinical evaluation reports according to MEDDEV 2.7.1 rev 3. This is done in close collaboration with the client for use in updates or the approval process of Notified Bodies in the CE marking of the products.

Monitoring
Monitoring of all types of projects; Clinical Studies phase I-IV, Non-Interventional Studies, Quality Compliance Projects etc.

Auditing
Audits according to relevant Company Standard Operating Procedures (SOPs) or International Committee on Harmonisation (ICH) guidelines as specified by the client.

Advice
Advice and support on Clinical Projects Management e.g. in Investigator Initiated Studies, Academic Research Studies that are not sponsored by the pharmaceutical industry etc.