Celerion deploys a regionally-based monitoring staff to minimize travel and maximize time on site. Our CRAs are commonly from a life-science background with over 10 years’ experience in the field as a CRA. With a focus on quality and data integrity, Celerion CRAs complete a rigorous training curriculum assuring compliance with ICH GCP, as well as all state and local regulations.
Our clinical monitors oversee the progress of your study to ensure that progress is conducted, recorded, and reported in accordance with your protocol, keeping in mind a variety of considerations such as objective, purpose, design, complexity, blinding, size, and endpoints of the study. Celerion employs a CORE Monitoring approach which consists of a compliance-oriented monitoring process and is designed to take into account each particular project and each study site. Every monitoring plan is tailored to the specific study. The Project Manager works with you to determine the most effective and cost-efficient monitoring plan including, standard onsite monitoring, central monitoring, risk-based monitoring or a hybrid to meet your project objectives.
Celerion develops a flexible clinical monitoring plan that includes the proposed frequency and duration of the Routine Monitoring Visits (RMVs) and your data entry expectations, but allows for adjustments in visit frequency dependent on the needs of the study. We systematically evaluate the compliance of the conduct of the study to the protocol, perform Source Data Verification (SDV), ensure the safety and welfare of the subject has been protected, and that the conduct of the study has complied with applicable GCPs and local/national regulations and guidelines. Acting as an extension of your team, our monitors seeks to establish true partnerships between study sponsors, research sites and the project team.
Highly qualified and experienced monitors will be added to the project team to ensure compliance, training and support of the clinical site(s). Sponsor requirements can be integrated into the detailed Site Management Plan and monitoring expectations defined in the Clinical Monitoring Plan allowing for touchpoints and documented oversight. Prior to study initiation Protocol and Therapeutic training will be completed and documented. On-site and remote monitoring activities, issue escalations, deviation management, training, and follow-up will be documented in monitoring reports. As part of the risk management strategy site Initiation will focus on training the site to conduct the protocol with special emphasis on procedures not routinely completed at the site. All queries, issues, deviations, and files will be closed prior to site closure.
Our experienced monitors are held to a consistent, high level of training including GCP, electronic data capture (EDC), and Celerion’s very stringent SOP curriculum. Our clinical monitoring team is experienced in many different EDC platforms and utilizes our CTMS to facilitate greater tracking and accountability The monitoring management team meets weekly to review projects and follows-up on outstanding items.
Full Service Global Clinical Development
Celerion, a full-service, early clinical CRO, is the leader in accelerating development for Phase I-IIb. Our unique combination of medical expertise, clinical operations experience and scientific excellence, enables you to make timely decisions with expert advice and high-quality data. Our leadership in clinical pharmacology through Proof-of-Concept is focused on helping you translate your science to medicine.
