Cromos Pharma can manage both single- and multi-center phase I-IV trials in a wide range of therapeutic indications. We also support the conduct of bioequivalence studies.
Our project management team is proactive with effective communication across the spectrum. Responsibilities, processes, and reporting lines are clearly defined early on in each project. These procedures are approved in a stepwise manner to ensure complete transparency.
With every study that we conduct, we appoint a Project Manager with experience in the respective field of research, who acts as a primary liaison for the Sponsor and gives your study absolute priority. This ensures that timelines are met, quality is maintained, appropriate training is delivered, and the budget is adhered to.
We employ only experienced physicians to monitor our clinical trials. They are citizens of their respective countries, fluent in English and have unique knowledge of the local medical community and its medical practices and standards. Our CRAs have undergone extensive training to ensure complete ICH GCP compliance, have industry-related experience of 5+ years, and have research experience of at least 3 years.
While working with us you can be assured that the lead CRA assigned to your study will not be replaced (except for force majeure situations). It is our policy to keep the same CRA for the lifetime of your study.
We also have dedicated staff available 24/7 to reply to your study inquiries and to provide support to the clinical trial sites.
Cromos Pharma has dedicated procedures and an experienced team for unblinded monitoring, including project managers who manage the parts of trials related to unblinded drug management, and CRAs with vast experience in both onsite and remote unblinded monitoring. Our unblinded team has successfully participated in EMA inspections with no significant findings.
It is well known how important feasibility studies are to estimate recruitment projections and to the successful conduct of a study. Our dedicated Feasibility Team evaluates all aspects of your proposed study and uses local knowledge and expertise in its diligent site selection process. This includes epidemiological analysis, regulatory issues, enrollment, competitive landscape, challenges with logistics, support with clinical trial logistics, and timelines for approval by regulatory authorities.
To obtain reliable perspectives on the study, our feasibility approach builds on personal relationships and communication with Principal Investigators (PIs) and Key Opinion Leaders (KOLs), rather than on the generic distribution of questionnaires. We have excellent personal relationships with a significant number of KOLs and scientific experts who are willing to act as PIs and/or as members of Scientific Advisory Boards, and Data Safety Monitoring Boards, for our clinical trials. Our well-established relationships with local medical communities give us direct access to key scientists at principal clinical research centers across our jurisdictions.
Cromos Pharma’s team has experience in the organization of protocol draft reviews by local KOLs, which allows our clients to obtain independent feedback from scientific and practical points of view at an early stage of protocol development.
Additionally, we use a closed cycle approach for the start-up process: on a regular basis we involve our Clinical Operation teams, Regulatory Managers and Medical Writers to assist in comprehensive capability/feasibility assessments. Gathering early and in-depth feedback from all our departments in the process of protocol development adds significant value to the success of the proposed clinical programs.
We strongly believe that careful selection and evaluation of Investigators is critical to successful enrollment and the quality of our studies. Consequently, we have created a sophisticated database of potential Investigators with a built-in proprietary system, to evaluate and grade their performance at the end of each study.
Cromos Pharma manages both single- and multi-center phase I-IV trials, regional, multi-country, and global studies, as well as bioequivalence studies, in a wide range of therapeutic indications.
For global studies, there is generally one central PM, (often US-based, for US clients), with additional PM(s) for local country venues. They report to the global PM so that our Sponsors have one point of contact that speaks their native language and is located in their time zone.
When running multi-national trials, we employ the most experienced physicians as PMs and CRAs. They are citizens of their respective countries, fluent in English, have exceptional 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 5 years industry-related experience.
With Cromos Pharma 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.
Whenever possible, we employ a regional site cluster strategy 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 of the trial, from Site Selection to Site Closeout.
Cromos has dedicated staff available 24/7 to reply to study inquiries and provide support to our Sponsors and research sites.
Cromos Pharma has over 18 years of experience in managing all aspects of clinical trials across a range of therapeutic areas. With operations in the US, Central and Eastern Europe we combine global expertise with profound local market knowledge to deliver end to end solutions supporting our pharma and biotech clients.
