Services Clinical Development Early Stage
Drug Safety
and Pharmacovigilance
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Patient Safety at the Forefront: Our Unwavering Commitment
At Accelsiors, we embrace a steadfast approach toward patient safety – it’s our absolute priority. Our proficient team, enriched with expansive experience in medical management and pharmacovigilance, meticulously monitors and reviews safety parameters. Together, we navigate the rigorous terrain of international regulatory requirements with unwavering focus and dedication.
We believe in the power of collaboration and this is reflected in our dynamic approach. Partnering with our clients and pertinent DSMBs, we engage in regular reviews and verification of safety parameters. Our team also plays a crucial role in providing comprehensive training to our staff and Investigators.
To provide seamless service and establish clear expectations, we curate study-specific plans at the beginning of each trial. These plans outline the precise roles and responsibilities of all involved parties – Accelsiors, our clients, Investigators, and third parties (when applicable). They serve as tangible reflections of contractual agreements and obligations, defining the applicable regulatory requirements and the SOPs to be adhered to.
Building enduring, trust-based relationships, we deliver personalized safety-centric clinical trial services tailored to your needs
Our Safety Imperatives:
- Enrollment of Eligible Subjects: We implement a thorough Eligibility Verification-Confirmation Process to minimize the risk of enrolling subjects who do not meet all protocol-defined eligibility criteria.
- Ongoing Patient Safety: Continuous and periodic reviews of safety data ensure early identification and appropriate handling of potential safety signals. Our medical and pharmacovigilance staff are at the ready 24/7, prioritizing patient safety and offering invaluable support to Investigators.
- Compliance Adherence: We operate in full accordance with local, national, and international guidelines, including Good Clinical Practice (ICH-GCP), as well as regulatory requirements. We navigate the intricacies of local and national regulations pertaining to clinical trial safety monitoring and reporting, ensuring transparency and compliance at every level.
At Accelsiors, our goal is to build enduring, trust-based relationships, delivering personalized services tailored to your specific needs. Our study-specific plans serve as the guiding beacon, illuminating the path to successful, safety-centric clinical trials. Trust Accelsiors, where patient safety is not just a priority, but our core mission.
Trust Accelsiors to navigate the intricacies of clinical trial safety with unwavering dedication and expertise
We are a truly scientifically and quality-driven CRO. We not only monitor a study, but we ensure that our subject matter experts are optimally driving the study from design to execution.
Allow us to maximize the value of your clinical development program. We will ensure that your study is performed based on the scientific understanding, medical knowledge, regulatory compliance, and experience of our team.
Here at Accelsiors, we strive to build long-term, trusting relationships and provide personalized services tailored to your needs. Study specific plans are prepared at the beginning of the study, in close collaboration with the Sponsor, in order to define the exact roles and responsibilities of Accelsiors, our Customers, Investigators and third parties (if applicable). These plans reflect contractual obligations and agreements, and define the applicable regulatory obligations, applicable SOPs and procedures to be followed.
Safety and Medical Management Services
Medical Management
- Eligibility Verification-Confirmation process
- Medical consultations (e.g. eligibility criteria, protocol design, requirements and restrictions)
- Review and analysis of safety listings and tables
- Safety signal detection and analysis
- Medical coding
Data Safety Monitoring Board (DSMB) management
- Member selection
- Charter development
- Meeting support and coordination
Pharmacovigilance
- 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
Management of endpoint adjudication committees
Management of diagnostic confirmation Panels
For further details please visit: Accelerant™
