clinical management
Managing early access to medicines
These programs are expected to benefit seriously patients with life-threatening, long lasting or seriously disabling illnesses who currently need to be treated with a drug under research, need to have access to medicines under other conditions than those authorized, or who have a disease for which no medicine has yet been authorized in Spain but is authorized in other countries. The compassionate use route may be a way for patients who cannot enroll in an ongoing clinical trial to obtain treatment with a potentially life-saving medicine.
- The benefits of implementing Managed Early Access Programs are important, not just for patients and healthcare professionals who have run out of treatment options, also for the pharmaceutical companies that hold the products that could help.
- ebers understands that while a Managed Early Access Program may be one of the important mechanisms your company is employing to support patient access, your main focus will always be to get a product to market as effectively and efficiently as possible.
- We develop ethical and regulatory compliant strategic solutions for pharmaceutical companies enabling a fast and efficient response to patient demand outside of traditional access routes.
- We offer a broad experience in management of Early Access Programs and direct knowledge of requirements. With our experienced and dedication you’ll have effective management.
Improving patient´s health
When patients have a serious or life-threatening diseases and they have exhausted all commercially available treatment options they would like to know that the treatment needed will be available and if there may still be medicines that are otherwise unavailable which could help. If there’s a drug that could benefit the patient and which is currently unavailable for whatever reason, we can help. We want patients get the treatment that they need. We are dedicated to improving patient care and quality of life.
Project management and monitoring activities
Ebers is committed to highest quality. Our team ensures that your study runs smoothly and on a continuous basis over its entire duration. The team facilitates the design process and performance, ensuring achievement of the established goals.
Outsourcing of Project Coordinators, Study Coordinators/Data Managers, Renting CRAs that provide special support to the study team when needed (deadlines, maternity leaves, sick leaves, etc).
The tasks we cover within project management area are:
- Start Up. - Feasibilities. Selection of sites and investigators. - Project coordination. - Project management plans, communication and risk management. - Setting out monitoring and monitoring milestones. - Periodic follow-up meetings to assess project compliance. - Leadership of all tasks affecting project development. - Coordination and support for the entire Project Team designated to the study. - Investigator Meetings. - Site agreements management. - Development of protocols, case report forms and needed documents. - Ammendments submission and updated reports. - Inititiation, monitoring and close out visits. - Pharmacovigilance. - Biological Samples management. - Patient Randomization. - Updated periodic status of the study progress and status. - Verification of source documents and case report forms. - Remote monitoring. - Resolving of queries.