Project management & monitoring

Project management

We support your trial success from the opening of the first site to the closing of the last one, providing local, regional, and global project management.

Experience: Our experienced project managers coordinate all activities related to the study, manage study timelines and budget and maintain close communication with sponsor, project team, and sites.
Timing: Project management group works on keeping each project on time and within the planned budget.
Knowledge: Each project team is motivated and integrated, with local expertise and therapeutic experience and knowledge.

Regardless of the size and scope of the project, we provide personalized service that caters to your project requirements.

Monitoring

We provide field monitoring, site management, and administration services. Routine monitoring is performed according to ICH GCP rules, 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 EDC studies
CRF review
Documentation maintenance and update
Regular contact with sites between onsite visits
Drug inventory and accountability
Safety review
Source Data Verification (100%)

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, principles and standards of good clinical practice (GCP). We take care of creation and maintenance of TMFs for ensuring compliance of the study.
Expert CRAs

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 specialized 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 to include various 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 the site staff has a focus on open, effective communication. The CRAs strive to provide training and support for ensuring patient safety, data quality and maximizing patient enrolment.

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CRO services for pharma & biotech

We conduct multinational clinical trials for pharma, biotech, and medical device companies in across Europe.

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Our Experience

Whether you are experiencing a challenging pharmaceutical trial, a project is slow to progress, or your trial has come to a standstill, we can get it back on track with our knowledge of site, vendor and trial management, operations, and regulatory affairs.

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Clinical operations

Your clinical trial will be run by local project managers across 10+ countries and clinical research associates (CRA) with an in-depth knowledge of local cultural and regulatory environments.