Simbec-Orion is a leading CRO experienced in site management and clinical monitoring, with an extensive team of compassionate CRAs. We run trials from phase I to phase III and understand that effective clinical site management and monitoring is pivotal to the success of a clinical research study. We’re dedicated to providing you with high quality, reliable study data.
Clinical trial site management
Our clinical trial site management services include:
- Site selection
- Feasibility and risk assessments, tailored to country-specific requirements
- Contract and budget management
- Preparation of site documentation
- Ethics Committee and Regulatory documentation submissions
- Patient recruitment and retention
- Training for site staff
- Dedicated, de-centralised CRAs
- Clinical monitoring through every stage of the clinical trial
- Site communication strategy
- Drug accountability
- Transparent reporting
Planning to close-out
Clinical trial site management is essential to the success of the clinical research trial. From planning and execution to close-out, every step must be carefully managed both for patient safety and for the product’s development.
Our team of CRAs are experts in communication between investigator site staff, Project Managers and sponsors. Their goal is to ensure patient safety, while providing the highest quality data that meets current regulations. They drive the focus of the clinical trial at site management level.
Site management is most often incorporated into our full clinical trial management services, but can be provided as a stand-alone service.
Our Clinical Research Associates (CRAs) are dedicated, compassionate and effective individuals with experience managing investigator sites and delivering clinical monitoring services. Each study will also have a dedicated Project Manager.
The CRA team at Simbec-Orion is decentralised – meaning each individual is located close to the site to facilitate the strongest lines of communication, driving patient recruitment and retention, and are on-hand for all site management.
They are regularly trained in clinical trial monitoring procedures, country-specific regulatory guidelines, ICH-GCP and trial-specific information to ensure they follow the most up-to-date practices and provide an unparalleled level of service.
Hear from one of our CRAs in our blog: A day in the life of a CRA.
Each CRA is trained in country-specific regulatory requirements and is experienced with ICH-GCP. They ensure patient safety and the integrity of the trial by assessing that site staff are performing the study according to Good Clinical Practice and all appropriate regulatory guidelines.
They are familiar with creating and maintaining documentation, as well as producing submission documents.
They can also train site personnel and adapt training according to the specific trial and site needs.
Clients Say About Us
The people working at Simbec Orion are dedicated, very professional and they cover all aspects of clinical research. A team will be set up for your project, who will have a strong focus on your study in a very open minded and friendly atmosphere. The studies I have outsourced to Simbec Orion, have been successfully managed and performed. I will use Simbec Orion in the future and I can strongly recommend them to other pharmaceutical companies.
Tina Lidén Mascher, Head of Clinical Operations