Ergomed services
Site Support Services
Ergomed`s patient-centric site support services are the cornerstone of high recruitment and retention. Almost 40% of sites miss enrollment targets, while 11% do not recruit a single patient. These are difficult statistics to accept when you need your trial finished on time and within budget. Clinical trials are labor-intensive for the highly skilled medical staff who are involved in them at the sites. Ergomed’s site support services revolve around the patients, offering support with project management, study monitoring, site management and study physician support.
Project Management Services
Ergomed offers project management services for clinical research that you can trust. We are proud that more than 75% of our business is repeat or referral, so driven by high satisfaction among our customers. This is a testament to the unrivaled expertise, professionalism, and global experience of our project management teams, which have performed clinical research studies in more than 60 countries worldwide. Our project management teams combine experience with robust, data-driven processes, offering you the confidence you need in patient recruitment and retention, financial control, and the quality of the data. More than 40% of our clinical research project management department have earned Ph.D., MD, or advanced degree qualifications. Our clinical project managers are passionate about bringing new therapies to patients while also proactively managing finances and timelines.
Clinical Monitoring Services
Effective clinical monitoring is essential to a successful trial and expediting a drug’s successful launch onto the market. Setting up the first site in a trial is a major milestone but the last site is just as important, maximizing the potential for patient recruitment. Our highly trained, expert and safety-oriented clinical research professionals provide clinical trial monitoring services that are tailor-made to your protocol. Working together with site management and study physician support, the clinical monitoring team embodies Ergomed’s patient-centric approach to help you navigate all stages of a clinical trial. Our clinical trial monitoring team has a minimum of an undergraduate degree in life science or equivalent education and experience, and an average of four years of clinical research experience, with experience across all phases of trials.
Study Start-Up and Activation Services
Ergomed delivers agile, data-driven and fast study start-up. A well-defined study start-up and activation strategy can significantly shorten your overall clinical trial, giving you a competitive advantage and improved chances of success. At Ergomed, we begin study start-up and activation planning as early as the request for information (RFI) stage, developing a study start-up plan that will be enhanced throughout the bidding process so that it is ready when needed. Our global coverage and data-driven approach also ensure we can identify rapid start-up sites with the best patient population to deliver the ‘first patient in’ (FPI) milestone. Led by a dedicated study start-up manager, we mobilize and synchronize our feasibility, site management and regulatory affairs resources to achieve even the most aggressive timelines.
Regulatory Affairs Services
Global regulatory framework assessment tool. This heat-map assesses the suitability of the country`s regulatory framework based on your protocol. Simply enter details of your trial design to see which countries will facilitate fast approval and which ones will be more challenging. The fastest countries will be colored the darkest, more challenging the lightest and white where it`s not possible. These are estimated based on a number of variable factors. Each project is unique and we would be happy to provide you with tailored analysis based on more specific project details and milestones.
