Project management

Monitoring

We provide field monitoring, site management, and administration services. Routine monitoring is performed according to ICH-GCP standards, FDA guidelines, and local regulatory requirements.

Monitoring activities include:

• Site staff training – ICH-GCP training
• Regulatory requirements compliance control
• Protocol compliance control
• Remote monitoring in Electronic Data Capture (EDC) studies
• Case Report Form (CRF) review
• Documentation maintenance and updates
• Regular contact with sites between onsite visits
• Drug inventory and accountability
• Safety review
• Source Data Verification (SDV)

Trial Master File (TMF)

A complete Trial Master File (TMF) is crucial for compliance, as it collects all the essential documents used by sponsors, CROs, and investigators for managing the trial. Monitors, auditors, and inspectors can use it to review and verify that the study has been conducted in line with the applicable regulatory requirements, including the principles and standards of Good Clinical Practice (GCP). We take care of creation and maintenance of TMFs, and we also have experience with electronic TMFs (eTMFs).  

We provide sponsors with highly qualified Clinical Research Associates (CRAs), which substantially reduces the overall cost of the project and ensures its timely completion. In addition to on-site responsibilities, each CRA is responsible for site management, documentation and follow-up activities to ensure that site staff remains motivated and focused. With backgrounds in life sciences, medicine, or pharmaceuticals, all CRAs undergo regular intensive training designed exclusively for their expertise. Clinical development training programs are prepared in cooperation with specialised training providers.

With a focus on the patient, we value:

• Safety
• Patient rights
• Timely patient recruitment
• Data integrity

Our CRAs perform comprehensive site management and monitoring activities, covering a range of different types of monitoring visits:

• Pre-study qualification visits
• Interim monitoring visits
• Initiation visits
• Close out visits

All activities are performed in accordance with ICH-GCP to ensure all investigational sites are compliant with all applicable regulations and protocol requirements. We also provide ICH-GCP training. 

Our CRAs play a major role in the successful conduct of a study. The relationship between the CRA and site staff focuses on open, effective communication. The CRAs strive to provide training and support for the staff to ensure patient safety, data quality, and maximising patient enrolment.