LINK combines a dedicated team of experienced and highly educated clinical trial experts with the local regulatory and scientific expertise needed to move your clinical project swiftly towards regulatory approval.
We are flexible and prepared to meet our customers' needs in any aspect of clinical trials that might be needed, including phase I-IV protocol development, feasibility, trial execution, project management for phase I-IV, data management, drug safety monitoring, statistical analysis and medical writing.
We can also perform services within selected parts of the clinical development process such as:
- Project management
- Feasibility
- Trial design
- Protocol development
- Case Report Form (CRF) design
- Site evaluation and selection
- Investigator meetings
- Clinical trial applications to regulatory authorities including preparation of IMPD/IB: the Norwegian Medicines Agency, medical research ethics committees, Biobank, the Data Inspectorate
- Monitoring of clinical trials
- Pharmacovigilance (drug safety)
- Document management
- Trial close-out
- Clinical trial reports
- Data management
- Biostatistics
- Health economics analysis
- Scientific articles
- "Proof of concept" studies
- Bioavailability and bioequivalence studies
- Outsourcing of clinical trial professionals
- Training and coaching of clinical trial professionals
- Training of investigators and other site personnel