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.
Skill and experience are only the start; then the intangibles take over; flexibility, innovation, integrity. We apply these principals to our project management services around the globe and across a wide range of therapeutic indications. Integrating our deep scientific capability and our project management expertise, our goal is your success.
Celerion’s highly experienced project managers will help to successfully navigate the landscape of clinical development. Our project managers are skilled at leading, monitoring and analyzing all aspects of your trial – operations, timeline, budget and quality. They will provide expert advice and leadership of multidisciplinary drug development teams, integrating nonclinical, clinical, medical, and regulatory disciplines. We work with you from study start-up through submission of the integrated clinical study report. We become a seamless extension of your organization to execute your studies, making your R&D spend more productive.
We help you make strategy and prioritization decisions sooner and smarter, and with better information. Celerion project managers are experienced with early risk identification, which is crucial to the success of a development program. We identify those issues that are likely to be obstacles during the development process and can get you from first-in-human through proof of concept as fast as possible.
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.
At the heart of your study is the medicine. With an average of more than 25 years of academic, clinical and industry experience, our medical monitors have deep therapeutic knowledge and clinical experience. We provide both strategic and specific advice to sponsors, the sites and project teams throughout the life of your study.
Prior to the study, we provide:
During and after study conduct:
Our medical monitor will develop a comprehensive medical plan, with your approval, that covers such elements as:
All of this is executed with full transparency and cooperation with the sponsor, through study meetings, conference calls, etc.
We apply our depth of knowledge and experience to ensure your study is safe and accurate.
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