Project management & monitoring

Project management

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

Experience: Our experienced Clinical Project Managers (CPMs) coordinate all activities related to the study, including managing study timelines and budget, as well as maintaining close communication with the sponsor, project team, and study sites.
Timing: The project management group works on keeping each project on time and within the planned budget.
Knowledge: Each project team is highly skilled and motivated, with local expertise, therapeutic experience and knowledge.

Clinical Project Managers (CPMs)

A Clinical Project Manager (CPM) is a person who has the overall responsibility for the successful initiation, planning, design, execution, monitoring, and closure of a project. The CPM can be appointed for the entire project, or for selected parts of the project. As a sponsor, it’s crucial to have one point of contact for our entire team and have the support of an experienced CPM with the expertise to offer insightful solutions to challenges and obstacles, while ensuring that your project is delivered on time with quality.

Project management activities include:

Development of clinical project plans and timelines
Establishing the necessary documentation for regulatory and ethics committee approvals
Coordinating the preparation of study documents such as the study protocol, informed consent and patient information, case report forms, and study files.
Ensuring all parties are well-informed throughout the study
Site selection, investigator meetings, as well as site training and documentation
Proactive risk management
Vendor oversight
Implementation of the Electronic Data Capture (EDC) system
Development of clean file, study closure activities, and the clinical study report.

CRO services for pharma & biotech

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

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Our experience

Whether you are experiencing a challenging pharmaceutical trial, a project that 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 & trial management, clincal operations, and regulatory affairs.

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Clinical operations

Your clinical trial will be run by local Clinical Project Managers (CPMs) across 10+ countries and Clinical Research Associates (CRAs) with an in-depth knowledge of local cultural and regulatory environments.