In this blog, we will explore an important part of a CRO’s service portfolio which is to have a strong study management capability. Your study depends greatly on the CRO’s Project Manager (PM) and his/her experience. Whether you're a pharmaceutical company, medical device manufacturer or a biotech startup, this resource will be your short guide in choosing the right CRO for outsourcing study management tasks of your clinical trial.

The CRO’s project management services or the PM should be capable of the following critical aspects, including:

• Regulatory knowledge and compliance, i.e., profound knowledge of Good Clinical Practice (GCP), and the current legislation.
• Being a strong team leader with the ability to clearly communicate with not only the CRO internal team but also the sponsor and potential third-party vendors.
• Long-standing experience as a study (project) manager keeping budget, timelines and quality in a well-balanced triangle and never losing sight of the project goals.
• Ability to effectively steer a clinical study based on risk-management considerations and under the overview of the study sponsor.

A positive sponsor-CRO relationship is largely due to the CRO's project management team. Project Managers steer your clinical study through risky waters, ensuring regulatory compliance, leading the team, and making sure the study stays on time and within budget. Let’s have a look at some critical points on which you need to focus when selecting a CRO for outsourcing project management tasks.

As A Sponsor, you should consider the following key success factors:

The CRO’s expertise in study management based on the above-mentioned key capabilities is essential.

The CRO’s ability to tailor the study management strategies to your specific objectives and requirements, ensuring a customized approach taking potential risks into account.

A study-specific, effective communication plan with the CRO regarding study progress and issue escalation.

Transparent and concise description of processes and functions-specific tasks in the company’s quality management system.

Need operational support? Contact us to get to know our highly experienced study managers who will be eager to help you.

Autor: Dr. Christoph Ortland, October 2023