A special department within Ergomed, Ergomed Late Phase, is responsible for late phase studies set up and management; including study design, regulatory submission, patient outcome assessments, pharmacovigilance, and publication planning and medical writing support. In addition, our sister company PrimeVigilance specializes in the supply of product related pharmacovigilance services and links with Ergomed Late Phase as required by our clients to provide a comprehensive late phase service.
At Ergomed we understand the range of issues needing consideration in the conduct of late phase clinical trials and observational registries. Our approach to post approval research studies is to shift the focus to the site and patient needs. If appropriate, we work with Sponsors to gain input from physicians/patients/patient groups on additional data elements which would provide useful information to the physician or patient community in relation to the disease management. Investigators in late phase research programs are often not the most experienced clinical researchers and we place a lot of emphasis on ensuring the sites are trained.
We invest significant time upfront ensuring that the selected operational strategy is fit for purpose for each late phase activity we perform. Our Project Work plan includes a Risk Management plan, Communication protocols and Site Management plan. Local regulatory, ethical, data protection and contracting expertise is essential and our teams have specific late phase experience in project management, safety management, site monitoring, Site Management and other supportive services.
Ergomed Late Phase apply a ‘fit for purpose’ operational strategy, focusing on the specific late phase regulatory requirements and utilizing late phase experienced project teams. We can offer flexible structures such as on-site/remote monitoring and Site Management services and also assist sites and investigators by using call centre and web enabled site support tools to enhance recruitment and retention and to reduce administrative problems.
Based on the type of a late phase project we can offer a customized Site Management model. The main goal of the Site Management Model in observational study designs and disease management programs is to assist in the retention of patients in the study by improving logistics at the site level as well.