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Clinical research

Contract Research Services

CRO services in Europe for medical devices, in vitro diagnostic systems and drug-device combinations

Medextens CRO services cover the complete clinical study lifecycle according to Good Clinical Practices. We have experience in all clinical phases of product development in order to generate evidence of product safety and clinical effectiveness:

  • First-in-man experience,
  • Assessing conformity with the requirements defined in the European Directive applicable to the product (93/42/EEC, 90/385/EEC, 98/79/EC), thus warranting the CE Marking,
  • Addressing questions of clinicians, scientific societies, Health Technology Assessment workgroups, payers and purchasers.
CE Marking

Clinical investigations

scope

Clinical investigation plan and appendices

Medextens ensures protocol completeness and consistency: Purpose, objectives, target population, study design, methods, endpoints, statistical plan, sample size and planning.

We develop the case report forms, patient information and consent document, the investigator brochure, investigator/site agreements. We apply for insurance policy according to national regulations.

Regulatory compliance

Medextens submits all local and national regulatory notifications and requests for authorizations.

Study conduct

Medextens ensures study conduct in compliance with GCPs defined in ISO 14155:2011, as well as national regulations. We compile the study master files and provide long-term archiving.

Clinical database management and Biostatistical analysis

Medextens enables remote data captures through web-based eCRFs as well as hard copy CRF with offline data entry.

Statistical script development and execution according to statistical plan and CRF. Statistical analysis conducted in STATA, R, SAS, SPSS on demand.

Statistical reports trace to script execution log and annotated CRF. Study reports, presentations and article manuscripts are written to need.

Observational studies

These studies are conducted according to specific methods, standards and regulations.

Product-specific studies

Invsetigator

Post-marketing comparative studies document differences between treatments or diagnostic systems in large numbers of patients during routine practice. Comparison is bias can be minimized using matching techniques such as propensity score matching (PSM).

Cohort studies gather evidence about product use and safety in clinical indications that reflect real life conditions. They can identify factors that influence outcomes.

Epidemiological studies

Prospective epidemiological or pharmaco-epidemiological studies are conducted when incidence, prevalence and their determinants, in specific populations cannot be accurately derived from available databases.