What We Offer

As every clinical study is unique, we offer flexible and customizable services designed to meet your specific requirements.

MAIN SERVICES

1. Study Coordination & Feasibility

Global oversight & operational alignment

Project coordination (Clinical Trial Manager), planning, tracking of patient enrollment, interactions with investigators and sponsors.
Key benefits: clear visibility, adherence to timelines, reduced operational risks.

2. Regulatory Submissions

Management of your submissions to competent authorities

Preparation and submission of regulatory packages, including through the CTIS (Clinical Trial Information System), management of amendments, follow-up, and regulatory compliance.
Key benefits: guaranteed compliance, significant time savings.

3. Monitoring Activities

From site selection to site closure

Feasibility assessment: evaluation of potential patient recruitment per site, logistics.
Site selection, study initiation, monitoring visits, source data verification, protocol and procedure compliance review.
Key benefits: quality assurance, reliable data, regulatory compliance, identification of deviations and support for corrective actions.

4. Operational Support to Sites

On-site assistance, training, logistics

GCP training for investigators and site staff, on-site support for study setup and conduct, logistical assistance, resolution of operational issues.
Key benefits: faster site readiness, improved patient recruitment, enhanced communication.

5. Clinical Research Technician (TEC) / Study Coordinator Missions

Clinical data management

Entry of data in e-CRFs, data checks, consistency review, management of patient visits/evaluations, processing of questionnaires, source data follow-up.
Key benefits: data quality, fast processing, adherence to timelines.

6. Clinical Research Nurse (IRC) / Study Nurse Missions

Technical support, patient assessments, biological procedures

Blood draws (with or without centrifugation), sample transport, ECGs, vital signs monitoring, administration of questionnaires according to protocol, technical support.
Key benefits: comprehensive management of clinical procedures, reduced workload for investigators, strengthened team coordination.