PSP & Post Marketing Services
PSP (Patient Support Program)
In an ever-evolving healthcare environment, Patient Support Programs (PSPs) have become critically important to better manage the diagnostic/therapeutic pathway.
PSPs help to improve the quality of life of both the Patient and family members through a set of personalized services delivered at home or remotely, including with the help of professional and validated technological solutions.
Designing and managing PSPs becomes critical to support the patient to follow treatment correctly, reduce patient travel from home, use health care resources more properly
PSP is an articulated system of services involving direct interaction with patients and/or caregivers with the purpose of:
adherence to treatment
Helping to manage drugs intake and/or disease consequences (affecting adherence to prescribed therapy, education, and awareness)
support
Emotional support and clarifying information for the best management of one's condition (counseling)
home nursing
Providing patients with the support of home health workers
automated processes
Support through reminder actions and automated processes the adherence to therapy
co-operation
Assist Center Medicians in maximizing the engagement of their Patients and Caregivers in the treatment pathway
materials management
Facilitate the reordering and delivery of materials
call center
Support via Call Center (also 24h, 7/7)
GB PHARMA acts as a partner in needs analysis and subsequent definition and management of PSPs by guaranteeing:
- Proper cost-effectiveness ratio
- Total compliance with pharmacovigilance requirements required by local legislation
- Protection of personal data and privacy
The Sponsor wishing to promote the PSP service can achieve its goals of supporting the Patient simply by contracting GB PHARMA, which will directly manage the various actors involved.
OUR PLUS
GB PHARMA‘s established experience in Pharmacovigilance and Clinical Trial management (including Drug Accountability and its management) and Patient Association management makes GB PHARMA a reliable and highly qualified provider of Patient Support Programs.
GB Pharma offers the necessary expertise to directly fulfill GVP activities associated with PSP, such as collection of ADRs, special situations, PQCs and any other relevant safety information.
As Adverse Events are “Solicited Reports”, GB PHARMA has the requirements and experience to fulfill the necessary GVP activities when needed and in accordance with the current legislation “ON SPONSOR BEHALF”.
Collection of ADRs, special situations, PQCs and any other information relevant to safety and managed through:
- Expedited reporting
- Reconciliation
- Final Report
Survey
Market research is increasingly a priority: in-depth knowledge of one’s target market is a necessary tool for facilitating business decision making, creating a healthcare development plan, and of course ensuring better patient care, which remains the heart of the healthcare industry.
Improving the Patient Experience and Organizing Market Choices Based on Reliable Data.
GB Pharma ‘s experience in Survey and market research activities began in 2010 with drugs and medical devices. We have been entrusted with drug surveys related to:
- Osteoporosis
- Pain
- Rheumatology
- Cardiology and cardiovascular disease
- Parkinson’s disease
Experience with medical devices before the enactment of MDR 745/746:
- Stents
- Implantable defibrillators
- Wearable defibrillators
- Pace makers
- Hip and knee replacements
Following the ‘European-wide enactment of MDR 745/746, the demand for surveys and our activity has drastically increased in the Medical device sector.
In this context, the purpose of the Survey is also addressed to the generation and collection of additional data to support the clinical evaluation of the device, within the PMCF plans.
Our most recent experience in SURVEY with Medical Devices for evaluation of the device itself as reliability , acceptability, performance:
- MD spirometry
- Spinal prostheses
- Medical gases
- MD for the administration of inhalation drugs
WHAT OUR SERVICE INCLUDES
Comprehensive Survey development and management
We develop and bring YOUR SURVEY to success by:
- Identification of the audience and target groups
- Preparation of the questionnaire (*) and its distribution through an ad hoc platform
- Drawing up contracts with the medical specialists involved and their management
- Data collection in the database
- Review of results and descriptive statistics
(*) The questionnaire may include various stages of evaluation in terms of:
- Functionality
- Acceptability
- Usability