Project management and monitoring services
Cromos Pharma manages both single- and multi-center phase I-IV trials, regional, multi-country, and global studies and bioequivalence studies in a wide range of therapeutic areas.
Our project management teams are proactive, with efficient communication across the spectrum. Responsibilities, processes and reporting lines are clearly defined at a very early stage of each project. With every study, we appoint an experienced Project Manager (PM) with in-depth knowledgein the study field and this PM acts as a primary liaison for the Sponsor ensuring your study receives absolute priority, that all timelines are managed to schedule, quality is maintained, appropriate training is delivered and the budget is adhered to. For global studies, there is generally one central PM, (often in the US, for US clients), and there may be more than one PM for local country venues. These local PMs, are, in some cases, also country managers and responsible for overseeing the regulatory and clinical aspects of the study in their home country. They report to the global PM so that our sponsors have one point of contact, and in their native language and time zone.
When running multinational trials we employ only experienced physicians to monitor our clinical trials. They are citizens of respective countries, fluent in English, have intricate knowledge of the local medical community and intricate knowledge of its medical practices and standards.
Our CRAs have undergone extensive training to ensure comprehensive adherence to ICH GCP standards and have at least 3 years industry-related experience.
While working with us you can be assured that the lead CRA assigned to your study will manage all site-related activities from initial RFP through to close out. It is extremely rare in Cromos Pharma for a CRA to be replaced once the study starts, an industry metric that we are very proud of. A keystone policy within Cromos Pharma is to keep the same CRA for the lifetime of the study which ultimately benefits the Sponsor and the study.
In the US, we employ a regional site cluster strategy if possible, and are nearly always able to use a local CRA, well experienced in the given therapeutic area, to monitor a group of sites. This saves money and time by reducing travel, and it also generally guarantees that a CRA will stay with his or her sites for the entire duration, from Site Selection to Site Closeout. Our CRAs in the US are also generally involved in, or responsible for, the feasibility of site enrollment for their assigned sites. This creates strong collaboration between CRA and site, and enhances enrollment performance considerably, as the collaboration is determined to achieve what they promised.
Cromos has dedicated staff available 24/7 to reply to study inquiries and to support our Sponsors and Investigators. If you are interested in any of our clinical research or regulatory services, please feel free to contact our Business Development team.