Our Services:

​Design, planning and management of clinical trials:

• Study Feasibilities and Strategy Consultation

• Projects coordination, all monitoring activities

• Development of the patient enrollment strategies

• Regulatory and Ethics Submissions

• Site and Investigator contract negotiations

• All monitoring and study oversight

• Clinical Study Supplies provisioning

• Site/Investigator payments

• Investigator Meeting organization

• Study design and statistical data analysis

• GCP training of the investigators

What can we offer:

• Access to a vast spectra of patients in different therapeutic areas

• attractable costs and fast recruitment of patients, which is possible because of the centralized healthcare system in Moldova

• Study feasibility, site qualification and selection

• Drafting and negotiating contracts with principal investigators and institutions

• Drafting contracts with the laboratory for safety investigations services

• Submission to the Independent Ethics Committee

• Collection, translations and review of site-specific essential documents

• Applying the documentation to the Regulatory Authorities for review, acceptance and approval in accordance with the applicable regulatory and legal requirements

• Local project management

• Organising on a local level Study-specific meetings of Investigators teams

• Management of sample collection and shipment to local or central laboratories

• CRF and DCF processing

• Trial monitoring according to ICH GCP guidelines

• Timely reports to the Sponsor to provide regular up-dates on the trial conducted

• Total local accounting and financial services for the purposes of the ongoing trials

• Cover of main therapeutic areas like oncology, cardiology, neurology, infectious, psychiatry, dermatology, gynecology, etc.

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