Clinical Trials Management
Our Clinical Trials Management is aimed at driving predictable and effective delivery of the clinical value assessment pertaining to food supplements, functional foods, novel foods, nutraceuticals, cosmetics and medical devices. We select professional partners, organize and directly accomplish all activities to design, develop and carry out a Clinical Investigation to fulfill the Clients’ requests.

To ensure the scientific validity and reproducibility of results, all members of our Scientific Committee are internationally recognized Opinion Leader Scientists, from primary Italian and international Academic Institutions. The Clinical Investigations are conducted in collaboration with the most important Universities in Italy, and throughout academic collaborations in USA, UK, and Switzerland, in accordance with the worldwide requirements, in primis with the provisions of the Declaration of Helsinki (current version), the Good Clinical Practice Standards from the ICH, the Federal Data Protection Act and the Italian Personal Data Protection Code.

BLYMUM carries out Clinical Trials Design & Project Management activities, throughout all key phases:

Experimental Design
Organizational planning, regulatory affairs, quality assurance, database management, patient information and consent set up, pre-study visits, Sponsor management;

Dossier Set-up
Ethics Committee interaction, trial registration;

Participant Enrollment
Assessment & compliance, enrollment;

Treatment & Monitoring Support
Logistic management, handling of SAE/AE, support for Sponsor’s QA auditing, customer care, monitoring, visits close-out;

Clinical Data Management
Data entry, CRF and EHR database management, Clinical Investigation Survey delivery.

The application of laws, regulations, mandatory standards and commendations is guaranteed. Safety and risk are constantly monitored and managed throughout the clinical trials execution.