We provide a set of services that guarantee quality, transparency and compliance with established regulatory standards of a clinical study.
At all times, we guarantee that, depending on type and stage of study, and needs of our clients, the best management is defined and developed to promote optimal implementation of the study. In addition, we have a network of expert partners in Clinical Research, guaranteeing that all needs are covered.
Depending on your needs, our activities may include:
- Management of multicenter, non-interventional and interventional studies, with medicines or medical devices;
- Management of both academic projects (investigator driven studies) and promoted by Industry;
- Feasibility: site identification, assessment and selection;
- Study Full Regulatory Submission (Local & Central);
- Clinical Monitoring.
- Site/Investigator Contract Negotiation;
- Contracts and payments management;
- Vendors’ management;
- Training of research personnel;
- Communication plan;
- Risk management and contingency plans;
- Data entry: developing methods to improve data quality in medical records;
- Project reports and metrics.
For further information or to get a quote this service, contact us.