Committed to profesionalism, our CRAs are Bachelors in life sciences and biology or PhD, all mastered in Clinical Trials education.
Heads of Department are always on the loop, providing support to ensure the highest quality.
The Monitoring Services cover:
Developed to answer clients requirements, using appropriates SOPs and following Project´specific parameters. The Monitoring Plan is aimed at improving timelines while keeping quality of data.
Initiation visits aim at training and providing the research team with updated and accurate information to guarantee a smooth and efficient start of the Project.
The objective is to oversee the study and to ensure the following principles:
- Protection of rights and well-being of the study subjects.
- Accurate, exact and verifiable data.
- Compliance with GCP.
- Monitoring report thoughfully prepared after each visit.
- Issues resolution.
- Remote visits.
We will ensure that all study documents, relevant correspondence and materials are properly managed according to sponsor instructions and regulatory requirements.
- Drug management: destruction, return, counting.
- Compliance applicable to biological samples.
- Study Files.
- Managing security reports and notificacion of adverse effects according to local regulation.
- Study material preparation and revisión: posters, triptychs and nurse procedures and so on.