CRO SERVICES

CRO SERVICES

We Bring Science to

LIFE

We provide clinical trial management services for the pharmaceutical, biotechnology and medical device industries.

The management of a clinical trial is more complicated than it might seem, as many actors are involved (manufacturers, sponsors, ethics committees, competent authorities, centres, foundations, researchers, legal departments, patients…). In addition, we will work under the standards of Good Clinical Practice and Harmonisation Guidelines (GCP-ICH Guidelines) to ensure the quality of the study. Being able to count on us as a partner in which to entrust the management of the study is the best choice. We act as a bridge between the sponsor, your company, and the other actors involved in the conduct of the clinical study.

Throughout the study, work is carried out in accordance with Good Clinical Practice (GCP) to ensure the quality of the study.

Preparation

Our first phase includes the development and review of protocols, adaptation of the necessary documentation to legislation, obtaining the necessary approvals from clinical research ethics committees and regulatory authorities, design and preparation of data collection notebooks, sample determination, selection of the best investigators and research sites, and final contract negotiation.

Monitoring

Once the trial has been approved, we at Geistek Pharma offer our services for monitoring, this includes control of compliance with the protocol and with the procedures established for the development of the study. Likewise, our pharmacovigilance services include the detection and action in case of the appearance of any Adverse Event.

Data

The final steps to ensure the success of your clinical study are data management, reporting and documentation control and storage.