Call Center
Site Assistance
The Call Center acts as the primary interface with investigational sites and answers questions concerning the following:
- Protocol-related questions
- Inclusion/exclusion criteria
- SAE reporting
- CRF completion
- Query resolution
- Protocol amendment updates
In Europe, the increasing involvement and influence of patients and recognition of patient-generated data, together with reduced availability of doctors for evaluation studies, prompted our creation of a separate division dedicated to direct management of patients in studies. To accommodate European regulations, the group was specially set up as an independent unit, with a thorough knowledge of and compliance with regard to all legal aspects of this area. This enables REGISTRAT-MAPI to include this type of service in its projects, without sacrificing regulatory, ethical or methodological demands.
Our Medical Logistics Assistance Center is uniquely equipped to facilitate and optimize conduct of European studies of all types. The advantages are both methodological and operational:
- Rapid, proactive data collection at source of patient-generated information, the natural historians of their condition
- Reinforcement of patient compliance with the protocol (information, training, health care management, reminders, paraclinical treatment and tests)
- Reduction in the work of Investigators through centralized assistance and local support (on-site or at patient's home)
Specializing in contact with patients and logistics, this group uses its know-how and experience to define and coordinate the combination of human and technological resources best adapted to the project.
Quality of Life Assessments and Diary Data Collection
The Call Center provides personal attention to study participants without injecting data bias while collecting data for:
- Patient reported outcomes
- Health economic information
- Performance assessments
- Patient diary collection
- Scripted questionnaires for online data capture
Services
Project-specific toll-free numbers may be established for your project for one or more of the following available services:
- General project-related call support
- Registration and regulatory document collection and processing
- Initial and ongoing training support
- Data query follow-up and resolution
- Tracking distribution of study materials and patient kits
- Monitoring study metrics (site and patient)
- Assisting with collection of safety documentation