Services

Our monitoring services are designed to ensure the highest standards of quality and compliance throughout your clinical trials. We understand the critical role of accurate and ethical monitoring to a clinical trial being successful and achieving its desired outcomes. With Caligeo Clinical, you can rest assured knowing that the following will be carried out in a timely and thorough manner:

• Site Qualification Visits
• Site Initiation Visits
• Interim Monitoring Visits
• Site Close Out Visits

Our Regulatory/Essential Document Preparation and Reviews are designed to ensure that your clinical trial meets the necessary regulatory requirements and standards. We understand the complexities and attention to details that is required to ensure regulatory compliance. We have a dedicated team of regulatory document/TMF experts who will work meticulously to prepare, review, and manage all essential documents ensuring regulatory compliance.

We recognize every client, study, and team have unique dynamics. Based on your specific needs, we carefully select customized leadership from a highly experienced team of professionals. We identify potential risks specific to your study and manage them proactively with pre-agreed Quality/Risk Management Plans (Incorporated into an overall Project Management Plan).

At Caligeo Clinical, we understand that protocol review is imperative to ensuring that your clinical trial is conducted successfully, and the integrity is never questioned. We recognize that a well-designed protocol is essential to achieving accurate and reliable trial outcomes.

Our team of experts will thoroughly review your protocol to ensure that it has a scientific rationale, ethically sound, and complies with all regulatory requirements.

Our Informed consent review services at Caligeo Clinical are designed to ensure the highest ethical standards and legal requirements are met. We understand that obtaining proper informed consent is a fundamental aspect of conducting ethical research.

At Caligeo Clinical, we understand that our CRF design and review service is integral to the collection of accurate and reliable clinical trial data. So much so that our team of experts will work closely with members of the client’s team to create customized CRFs that fit your specific study needs.

We understand Site Auditing & Inspections are essential components to the success and integrity of your clinical trials. At Caligeo Clinical, we specialize in conducting thorough audits and preparing designated clinical sites to meet all regulatory requirements and protocol specifications.

Our experienced team members will dedicate themselves to optimizing site performance and ensuring sites are compliant with requirements and following guidelines throughout the lifecycle of your study.

At Caligeo Clinical, we possess the expertise, resources, and methodologies to deliver high quality training programs tailored to meet study specific needs. Our team members will partner with your team to provide training in the following areas:

• Clinical Research Fundamental Training
• Computer Skills Training
• Clinical Trial Staff Training
• Clinical Trial Staffing/Recruitment
• Mentorship “Train the Trainer” Program