Services Consultancy in product development
Medical and PV Support
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Elevating Your Product Lifecycle with Our Comprehensive Medical and Pharmacovigilance Services
Custom-tailored Medical Strategies for Your Clinical Trials
At Accelsiors, we take pride in offering high-quality pharmacovigilance and purposeful medical services in support of the entire lifecycle of your products. Our dedicated Medical and Pharmacovigilance (PV) Team devises fit-for-purpose medical strategies tailored to meet the needs of your clinical trials. Whether you require assistance for a single clinical trial or comprehensive oversight for executing critical medical strategies throughout your product’s lifecycle, we have you covered. Moreover, our Medical and Pharmacovigilance Consulting team provides a full spectrum of consulting services, bridging any gaps that may emerge during any phase of your product lifecycle.
Compliance and Innovation: Pillars of Our Service
Our medical and PV services comply fully with major regulatory requirements. Coupling the expertise of our medical and PV teams with state-of-the-art clinical research technologies, we offer a new experience in medical management or PV support across all stages of your clinical development programs.
Your Medical Team Expansion Partner
Our experienced Medical Team is ideally positioned to provide a broad range of fit-for-purpose services. Should you need to expand your medical team, Accelsiors is ready to support you until your new members are fully onboarded. If you’re looking to establish a quality management system for your new Medical Department, we can assist with the creation of crucial quality documents such as SOPs, Management Plans, and more.
Navigating Your Medical Management Strategies
We offer guidance in developing your medical management strategies and more. We can also assist in the selection and qualification of key vendors with potential significant impact on your study outcome, such as central readers and analytical labs.
Taking Full Charge of Your Medical Management Needs
Ready to take full responsibility for medical management and monitoring services, Accelsiors stands at the ready. We can oversee DSMB and adjudication committee management, eligibility verification, and many other essential services. Partner with us and experience the benefits of seamless, comprehensive medical and pharmacovigilance services.
Medical & PV Consultancy MEDICAL SERVICES
We provide a broad range of services, from simple technical to strategic medical support for the entire lifecycle of your product(s).
Our Medical Services
Strategic Support
- Quality Management System set up for Medical Department
- Central monitoring system development and technology support
- KPI set up and maintenance
- Staff training
- Temporary substitution of key medical staff
- Medical presentation at investigators meetings
- Medical Information to health care providers
- Publications and Conference Strategy
- Budget Planning and support in investor meetings
- Development of Medical Master Slide Deck Formation
- Medical Information Strategy and support
Medical Monitoring
- Build up the system and support of eligibility verification of the patients
- Standard medical monitoring services
- Signal detection
Data Safety Monitoring Board (DSMB) and Adjudication Committees Management
- Member selection
- Charter development
- Meeting support and coordination
Scientific Inputs
- Medical input to protocol
- Medical input to IDB
- Medical Input to Final Integrated Study Report
- Medical input and review of MeDRA and other coding
Medical & PV Consultancy PV SERVICES
Accelsiors PV team provides pharmacovigilance support over the entire lifecycle of your product, from early input in the study design to post marketing activities.
Our Pharmacovigilance Services
Strategic Support
- PV system set up
- PV SOP development
- Updates on major and country specific PV regulatory requirements
- PV system auditing
- Set up of PV compliance monitoring
- Pharmacovigilance Management Plan development
Focused PV Activities and Services
- Periodic Safety Reporting (DSUR and periodic line listings)
- SAE/AE/ADR handling (collection, database entry and evaluation)
- Identification of AEs of special interest and appropriate handling
- Provision of CIOMS and/or MedWatch forms for all SAE reports within expected timelines
- Registration with EudraVigilance
- Overdose handling (collection, database entry and evaluation)
- Pregnancy handling (collection, database entry and evaluation)
- 24/7 safety surveillance – available to Investigators for all PV related questions
- Peri-marketing PV services
