Ozempic® (semaglutide) is a glucagon-like peptide (GLP-1) receptor agonist indicated for the treatment of Type 2 diabetes in adults.
ikfe CRO provides a wide range of services to pharmaceutical and biotechnology companies across the world. As a German-based full service contract research organisation, our pharmaceutical product development business ensures that clients benefit from our in-depth understanding of the international regulatory environment and our ability to professionally manage development projects and clinical trials.
We help clients to get their products to market quickly and cost effectively. Our flexibility gives clients the support they need and the freedom to scale their requirements at any time.
Drug development programme support
With our associated partners, ikfe clinic and phase I unit, ikfe laboratory and ikfe academy, we can provide expert help at every stage of the development programme.
Whether our clients require long-term support for complete development programmes, or specific capabilities for one-off projects, we offer the experience and expertise needed.
Diabetes and cardiovascular research
ikfe has broad experience in many different therapeutic areas. By providing strategic consulting at all stages of the development process we help our clients to efficiently move from bench to bedside.
Our involvement can start at the preclinical stage or at any point in the drug development process. We have performed diabetes studies at the highest scientific level in all departments for more than ten years, and we are the experts for diabetes and cardiovascular research in Germany.
Drug development consultancy, regulatory affairs and clinical operations services
ikfe CRO offers a range of services throughout the drug development process, including:
- Consultancy: registration strategies, trial design, medical monitoring and publication strategies
- Data management: database / CRF design, data capture (paper and electronic), data processing, query management, medical coding and statistics
- Regulatory affairs: submission and communication with competent authorities for IRB / IEC approval, and ad hoc safety reporting to competent authorities and IRB / IEC
- Medical writing: protocol writing, IB preparation, annual safety report, final and clinical expert reports, and presentation and publishing of trial results at congress and events
- Clinical operations: project and site management, site selection / feasibility, investigator meetings, monitoring and supply logistics
- Study drug / medical device: import / export, QP release, storage, labelling and logistics
Laboratory, metabolism and in-vitro diagnostics services
The ikfe research / central laboratory is CAP-accredited and ISO-certified. In addition to offering central laboratory services, the laboratory specialises in:
- Diabetes-associated auto-antibodies
- Glucose metabolism
- Bone metabolism
- Lipid metabolism
- Inflammatory markers
- Cardiovascular markers
- On-demand research in genetics, cell biology and proteomics
- Production of in-vitro diagnostics (e.g. RT-PCR, chip array, ELISA, HPLC and rapid tests)
Pk and Pd, dose finding, first-in-man and interaction studies
The ikfe clinic deals with a particular patient population, namely diabetes, cardiovascular and obesitas. The phase I unit handles Pk and Pd studies, dose finding studies, first-in-man studies and interaction studies. The outpatient unit is specialised in long-term studies and phase II-IV.
Medical, GCP and CRA training
The ikfe academy offers medical, GCP and CRA training, as well as marketing support, market research and event management.
Quality assurance audits
ikfe CRO offers a range of quality assurance services, including internal audits, on-site audits, system audits and randomisation.
Tresiba (insulin degludec) is the first, long-acting, human insulin indicated for the treatment of Type 1 and Type 2 diabetes. The drug was discovered and developed by Novo Nordisk.
Durlaza (aspirin) is a non steroidal anti-inflammatory drug indicated for the prevention of thrombotic events in patients with cardiovascular disease (CVD).